Details of the Drug Formulations

General Information of Drug (ID: DMHP21E)

• Drug Name: Hydromorphone Drug Info
• Synonyms: hydromorphone; Dihydromorphinone; Dimorphone; Idromorfone; Hydromorphon; Dihydromorfinon; Hydromorfona; Laudacon; DiMo; Hydromorphonum; 7,8-Dihydromorphinone; Novolaudon; Hidromorfona; Dilaudid; Dilaudid Oros; Hydromorfona [Spanish]; Dihydromorfinon [Czech]; 466-99-9; Hydromorphonum [INN-Latin]; Hidromorfona [INN-Spanish]; Palladone; 6-Deoxy-7,8-dihydro-6-oxomorphine; Morphinone, dihydro-; Idromorfone [DCIT]; Laudicon; Hydromorphone [INN:BAN]; Dilaudid-hp; 4,5-Epoxy-3-hydroxy-17-methylmorphinan-6-one; DiMo; Hydromorphone HCL; Dilaudid (TN); Hydromorphone (INN); Palladone (TN); Palladone SR (TN); Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-(8CI); (-)-(5R)-4,5-Epoxy-3-hydroxy-9alpha-methylmorphinan-6-one; (-)-Hydromorphone; (5alpha)-3-hydroxy-17-methyl-4,5-epoxymorphinan-6-one; 3-hydroxy-17-methyl-4,5alpha-epoxymorphinan-6-one; 4,5alpha-Epoxy-3-hydroxy-17-methyl-6-morphinanone; Hydromorphone prodrug

Indication

Disease Entry	ICD 11	Status	REF
Back pain	ME84.Z	Approved	[1]
Common cold	CA00	Approved	[1]
Cough	MD12	Approved	[1]
Pain	MG30-MG3Z	Approved	[2]
Chronic pain	MG30	Phase 3	[3]

• Therapeutic Class: Analgesics
• Cross-matching ID:
  PubChem CID: 5284570
  ChEBI ID: CHEBI:5790
  CAS Number: 466-99-9
  TTD ID: D04JHN
  INTEDE ID: DR0833
  ACDINA ID: D00315

Full List of Drug Formulations Containing This Drug

Hydromorphone 12 mg tablet

Company	Formulation ID	FDA Description
Paddock Laboratories,	F09823	Lactose monohydrate; Fd&c blue no. 1; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Titanium dioxide; Triethyl citrate; Polyethylene glycol 400; Polysorbate 80; Povidone k30; Silicon dioxide; Ammonio methacrylate copolymer type a; Cellulose, microcrystalline; Ethylcellulose (100 mpa.s); Hypromellose 2910 (3 mpa.s); Hypromellose 2910 (6 mpa.s)
Mallinckrodt	F09818	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Polyethylene glycol 3350; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Povidone, unspecified
Mallinckrodt	F09819	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycol, unspecified; Povidone, unspecified
Lake Eire Medical & Surgical Supply DBA Quality Care Products	F09820	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycols; Povidones
Actavis Pharma	F09821	Lactose monohydrate; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Sodium chloride; Talc; Titanium dioxide; Cellulose acetate; Copovidone; Hypromelloses; Polyethylene glycols
Trigen Laboratories	F09822	Lactose monohydrate; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Silicon dioxide; Cellulose acetate; Hypromellose 2208 (100 mpa.s); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 7000000; Polyethylene glycols; Polyethylene oxide 200000

Hydromorphone 32 mg tablet

Company	Formulation ID	FDA Description
Paddock Laboratories,	F09841	Fd&c blue no. 1; Magnesium stearate; Mannitol; Ferric oxide red; Propylene glycol; Talc; Titanium dioxide; Triethyl citrate; Polyethylene glycol 400; Povidone k30; Silicon dioxide; Ammonio methacrylate copolymer type a; Cellulose, microcrystalline; Ethylcellulose (100 mpa.s); Hypromellose 2910 (3 mpa.s); Hypromellose 2910 (6 mpa.s)
Mallinckrodt	F09837	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Polyethylene glycol 3350; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Povidone, unspecified
Mallinckrodt	F09838	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycol, unspecified; Povidone, unspecified
Actavis Pharma	F09839	Lactose monohydrate; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Sodium chloride; Talc; Titanium dioxide; Cellulose acetate; Copovidone; Hypromelloses; Polyethylene glycols
Trigen Laboratories	F09840	Lactose monohydrate; Magnesium stearate; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Silicon dioxide; Cellulose acetate; Hypromellose 2208 (100 mpa.s); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 7000000; Polyethylene glycols; Polyethylene oxide 200000

Hydromorphone 8 mg tablet

Company	Formulation ID	FDA Description
Paddock Laboratories,	F09856	Lactose monohydrate; Fd&c blue no. 1; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Talc; Titanium dioxide; Triethyl citrate; Polyethylene glycol 400; Povidone k30; Silicon dioxide; Ammonio methacrylate copolymer type a; Cellulose, microcrystalline; Ethylcellulose (100 mpa.s); Hypromellose 2910 (3 mpa.s); Hypromellose 2910 (6 mpa.s)
Mallinckrodt	F09850	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Polyethylene glycol 3350; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Povidone, unspecified
Stat Rx USA	F09853	Lactose monohydrate; Lactose, anhydrous; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Povidone; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycol
Trigen Laboratories	F09855	Lactose monohydrate; Fd&c red no. 40; Magnesium stearate; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Silicon dioxide; Cellulose acetate; Hypromellose 2208 (100 mpa.s); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 7000000; Polyethylene glycols; Polyethylene oxide 200000
Mallinckrodt	F09851	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycol, unspecified; Povidone, unspecified
Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care	F09852	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycols; Povidones
Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care	F09858	Stearic acid; Lactose monohydrate; Magnesium stearate; Cellulose, microcrystalline
SpecGx	F09859	Stearic acid; Lactose monohydrate; Magnesium stearate; Microcrystalline cellulose
Actavis Pharma	F09854	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Propylene glycol; Sodium chloride; Talc; Titanium dioxide; Cellulose acetate; Copovidone; Hypromelloses; Polyethylene glycols; Polyvinyl alcohol, unspecified
Aurolife Pharma	F09861	Anhydrous lactose; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
Precision Dose	F09863	Anhydrous lactose; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline
TAGI Pharma	F09864	Anhydrous lactose; Magnesium stearate; Silicon dioxide; Microcrystalline cellulose
Physicians Total Care	F09817	Anhydrous lactose; Magnesium stearate; Sodium metabisulfite
American Health Packaging; Lannett Company	F09857	Anhydrous lactose; Lactose monohydrate; Magnesium stearate
Rhodes Pharmaceuticals; Stat Rx USA	F09862	Lactose; Magnesium stearate; Sodium metabisulfite
Purdue Pharma	F09865	Anhydrous lactose; Magnesium stearate; Sodium metabisulfite
Bryant Ranch Prepack; West-Ward Pharmaceticals	F09860	Anhydrous lactose; Magnesium stearate

Hydromorphone 16 mg tablet

Company	Formulation ID	FDA Description
Paddock Laboratories,	F09829	Lactose monohydrate; Fd&c blue no. 1; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Propylene glycol; Talc; Titanium dioxide; Triethyl citrate; Polyethylene glycol 400; Povidone k30; Silicon dioxide; Ammonio methacrylate copolymer type a; Cellulose, microcrystalline; Ethylcellulose (100 mpa.s); Hypromellose 2910 (3 mpa.s); Hypromellose 2910 (6 mpa.s)
Trigen Laboratories	F09828	Lactose monohydrate; D&c yellow no. 10; Fd&c yellow no. 6; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Silicon dioxide; Cellulose acetate; Hypromellose 2208 (100 mpa.s); Hypromellose 2910 (5 mpa.s); Polyethylene glycol 7000000; Polyethylene glycols; Polyethylene oxide 200000
Mallinckrodt	F09824	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Polyethylene glycol 3350; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Povidone, unspecified
Lake Eire Medical & Surgical Supply DBA Quality Care Products; Mallinckrodt	F09825	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycol, unspecified; Povidone, unspecified
Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care	F09826	Anhydrous lactose; Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Sodium chloride; Titanium dioxide; Triacetin; Cellulose acetate; Hypromellose 2910 (5 mpa.s); Polyethylene glycols; Povidones
Actavis Pharma	F09827	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Sodium chloride; Talc; Titanium dioxide; Cellulose acetate; Copovidone; Hypromelloses; Polyethylene glycols; Polyvinyl alcohol, unspecified

Hydromorphone 2 mg tablet

Company	Formulation ID	FDA Description
Aurolife Pharma	F09833	Anhydrous lactose; D&c red no. 30; D&c yellow no. 10; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
Physicians Total Care	F09815	Anhydrous lactose; D&c red no. 30; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Rhodes Pharmaceuticals	F09834	Lactose; D&c red no. 30; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Bryant Ranch Prepack	F09835	Lactose, unspecified form; D&c red no. 30; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Lake Eire Medical & Surgical Supply DBA Quality Care Products; Purdue Pharma	F09836	Anhydrous lactose; D&c red no. 30; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care; Stat Rx USA	F09831	Stearic acid; Lactose monohydrate; Magnesium stearate; Cellulose, microcrystalline
SpecGx	F09832	Stearic acid; Lactose monohydrate; Magnesium stearate; Microcrystalline cellulose
American Health Packaging; Lannett Company; PD-Rx Pharmaceuticals	F09830	Anhydrous lactose; Lactose monohydrate; Magnesium stearate

Hydromorphone 4 mg tablet

Company	Formulation ID	FDA Description
Aurolife Pharma	F09846	Anhydrous lactose; D&c yellow no. 10; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
Physicians Total Care	F09816	Anhydrous lactose; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Rhodes Pharmaceuticals	F09847	Lactose; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Bryant Ranch Prepack	F09848	Lactose, unspecified form; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Cardinal Health; Lake Eire Medical & Surgical Supply DBA Quality Care Products; McKesson; Purdue Pharma	F09849	Anhydrous lactose; D&c yellow no. 10; Magnesium stearate; Sodium metabisulfite
Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care; Stat Rx USA	F09843	Stearic acid; Lactose monohydrate; Magnesium stearate; Cellulose, microcrystalline
SpecGx	F09844	Stearic acid; Lactose monohydrate; Magnesium stearate; Microcrystalline cellulose
American Health Packaging; Lannett Company	F09842	Anhydrous lactose; Lactose monohydrate; Magnesium stearate
West-Ward Pharmaceticals	F09845	Anhydrous lactose; Magnesium stearate

Hydromorphone 24 mg capsule

Company	Formulation ID	FDA Description
Purdue Pharma	F09868	Fd&c blue no. 2; Titanium dioxide; Synthetic black iron oxide; Ammonio methacrylate copolymer type b; Ethylcellulose; Steryl alcohol

Hydromorphone 12 mg capsule

Company	Formulation ID	FDA Description
Purdue Pharma	F09866	Titanium dioxide; Synthetic black iron oxide; Ammonio methacrylate copolymer type b; Ethylcellulose; Gelatin; Red iron oxide; Steryl alcohol

Hydromorphone 16 mg capsule

Company	Formulation ID	FDA Description
Purdue Pharma	F09867	Titanium dioxide; Synthetic black iron oxide; Ammonio methacrylate copolymer type b; Ethylcellulose; Gelatin; Red iron oxide; Steryl alcohol

Hydromorphone 32 mg capsule

Company	Formulation ID	FDA Description
Purdue Pharma	F09869	Titanium dioxide; Synthetic black iron oxide; Ammonio methacrylate copolymer type b; Ethylcellulose; Steryl alcohol

References

• [1] Hydromorphone FDA Label
• [2] Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health & Human Services. 2015
• [3] Clinical pipeline report, company report or official report of the Pharmaceutical Research and Manufacturers of America (PhRMA)