Details of the Drug Formulations

General Information of Drug (ID: DMZEPFJ)

• Drug Name: Demeclocycline Drug Info
• Synonyms: Bioterciclin; Clortetrin; DMCT; DMCTC; Declomycin; Deganol; Demeclociclina; Demeclocyclinum; Demeclor; Demethylchlorotetracycline; Demethylchlortetracyclin; Demethylchlortetracycline; Demethylchlortetracyclinum; Demetraclin; Diuciclin; Ledermycin; Methylchlorotetracycline; Mexocine; Novotriclina; Perciclina; Sumaclina; Demeclocycline Monohydrochloride; Demethylchlortetracycline base; Ledermycin hydrochloride; RP 10192; DMCT (antibiotic); Declomycin (TN); Declostatin (TN); Demeclociclina [INN-Spanish]; Demeclocycline (USP); Demeclocycline [USAN:BAN]; Demeclocyclinum [INN-Latin]; Demethylchlortetracycline (JAN); Ledermycin (TN); Tri-demethylchlortetracycline; [4S-(4alpha,4aalpha,5aalpha,6beta,12aalpha)]-7-chloro-4-(dimethylamino)1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide; (2E)-2-[amino(hydroxy)methylidene]-7-chloro-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; (2E,4S,4aS,5aS,6R,12aR)-2-[amino(hydroxy)methylidene]-7-chloro-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; (2E,4S,4aS,5aS,6S,12aS)-2-[amino(hydroxy)methylidene]-7-chloro-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; (2Z,4S,4aS,5aS,6S,12aS)-2-[amino(hydroxy)methylidene]-7-chloro-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; (4S,4aS,5aS,6S,12aS)-7-chloro-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide; 2-[amino(hydroxy)methylidene]-7-chloro-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; 6-Demethyl-7-chlorotetracycline; 6-Demethyl-7-chlortetracycline; 6-Demethylchlorotetracycline; 6-Demethylchlortetracycline; 6-Demetil-7-clorotetraciclina; 6-Demetil-7-clorotetraciclina [Italian]; 7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide; 7-Chloro-4-dimethylamino-3,6,10,12,12a-pentahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-naphthacene-2-carboxylic acid amide; 7-Chloro-6-demethyltetracycline

Indication

Disease Entry	ICD 11	Status	REF
Acne vulgaris	ED80	Approved	[1]
Actinomycosis		Approved	[2]
Acute gonococcal cervicitis		Approved	[2]
Bronchitis	CA20	Approved	[1]
Brucellosis		Approved	[2]
Chancroid		Approved	[2]
Lyme disease	1C1G	Approved	[1]
Lymphogranuloma venereum		Approved	[2]
Ornithosis		Approved	[2]
Pneumonia	CA40	Approved	[2]
Q fever		Approved	[2]
Relapsing fever		Approved	[2]
Rickettsialpox		Approved	[2]
Rocky mountain spotted fever		Approved	[2]
Staphylococcus aureus infection		Approved	[2]
Syphilis		Approved	[2]
Trachoma		Approved	[2]
Typhus		Approved	[2]
Urinary tract infection	GC08	Approved	[2]
Yaws		Approved	[2]
Sinusitis	CA0A.Z	Investigative	[2]

• Therapeutic Class: Antibiotics
• Cross-matching ID:
  PubChem CID: 54680690
  ChEBI ID: CHEBI:4392
  CAS Number: 127-33-3
  TTD ID: D0R9WP
  ACDINA ID: D00178

Full List of Drug Formulations Containing This Drug

Demeclocycline 150 mg tablet

Company	Formulation ID	FDA Description
Epic Pharma; Marlex Pharmaceuticals; PuraCap Laboratories	F05314	D&c red no. 30; Fd&c red no. 40; D&c red no. 27; Fd&c blue no. 1; Fd&c yellow no. 6; Magnesium stearate; Talc; Titanium dioxide; Triacetin; Crospovidone; Silicon dioxide; Carnauba wax; Cellulose, microcrystalline; Hydroxypropyl cellulose (type l); Hypromellose 2910 (10000 mpa.s); Polydextrose; Polyethylene glycol 8000; Starch, corn
Golden State Medical Supply	F05312	D&c red no. 30; Fd&c red no. 40; D&c red no. 27; Fd&c blue no. 1; Fd&c yellow no. 6; Magnesium stearate; Talc; Titanium dioxide; Triacetin; Silicon dioxide; Carnauba wax; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hydroxypropyl cellulose (type l); Hypromellose 2910 (10000 mpa.s); Polydextrose; Polyethylene glycol 8000; Starch, corn
Teva Pharmaceuticals	F05313	Fd&c red no. 40; Sodium stearyl fumarate; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hypromellose 2910 (3 mpa.s); Hypromellose 2910 (6 mpa.s); Povidone k29/32
Global Pharmaceuticals	F05310	Lactose monohydrate; Fd&c red no. 40; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Povidone; Silicon dioxide; Alginic acid; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols
American Health Packaging; Amneal Pharmaceuticals; AvKARE; Carilion Materials Management	F05309	Sodium lauryl sulfate; Fd&c red no. 40; D&c red no. 27; Magnesium stearate; Talc; Titanium dioxide; Polyvinyl alcohol; Alginic acid; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycols; Starch, corn
VersaPharm	F05311	Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Silicon dioxide; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polydextrose; Polyethylene glycols
Major Pharmaceuticals	F05308	Sodium lauryl sulfate; Fd&c red no. 40; D&c red no. 27; Magnesium stearate; Talc; Titanium dioxide; Alginic acid; Ethylcellulose, unspecified; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Polyvinyl alcohol, unspecified; Starch, corn
CorePharma	F05307	Sodium lauryl sulfate; D&c yellow no. 10; D&c red no. 7; Magnesium stearate; Sorbitol; Titanium dioxide; Alginic acid; Ethylcelluloses; Hypromelloses; Light mineral oil; Mineral oil; Starch, corn

Demeclocycline 300 mg tablet

Company	Formulation ID	FDA Description
Epic Pharma; Marlex Pharmaceuticals; PuraCap Laboratories	F05322	D&c red no. 30; Fd&c red no. 40; D&c red no. 27; Fd&c blue no. 1; Fd&c yellow no. 6; Magnesium stearate; Talc; Titanium dioxide; Triacetin; Crospovidone; Silicon dioxide; Carnauba wax; Cellulose, microcrystalline; Hydroxypropyl cellulose (type l); Hypromellose 2910 (10000 mpa.s); Polydextrose; Polyethylene glycol 8000; Starch, corn
Golden State Medical Supply	F05320	D&c red no. 30; Fd&c red no. 40; D&c red no. 27; Fd&c blue no. 1; Fd&c yellow no. 6; Magnesium stearate; Talc; Titanium dioxide; Triacetin; Silicon dioxide; Carnauba wax; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hydroxypropyl cellulose (type l); Hypromellose 2910 (10000 mpa.s); Polydextrose; Polyethylene glycol 8000; Starch, corn
Teva Pharmaceuticals	F05321	Fd&c red no. 40; Sodium stearyl fumarate; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hypromellose 2910 (3 mpa.s); Hypromellose 2910 (6 mpa.s); Povidone k29/32
Global Pharmaceuticals	F05318	Lactose monohydrate; Fd&c red no. 40; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Povidone; Silicon dioxide; Alginic acid; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols
VersaPharm	F05319	Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Silicon dioxide; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polydextrose; Polyethylene glycols
American Health Packaging; Amneal Pharmaceuticals; AvKARE; Major Pharmaceuticals	F05317	Sodium lauryl sulfate; Fd&c red no. 40; Magnesium stearate; Talc; Titanium dioxide; Polyvinyl alcohol; Alginic acid; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycols; Starch, corn
CorePharma	F05315	Sodium lauryl sulfate; D&c yellow no. 10; D&c red no. 7; Magnesium stearate; Sorbitol; Titanium dioxide; Alginic acid; Ethylcelluloses; Hypromelloses; Light mineral oil; Mineral oil; Starch, corn
Major Pharmaceuticals	F05316	Sodium lauryl sulfate; Fd&c red no. 40; Magnesium stearate; Talc; Titanium dioxide; Alginic acid; Ethylcellulose, unspecified; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Polyvinyl alcohol, unspecified; Starch, corn

References

• [1] Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health & Human Services. 2015
• [2] Demeclocycline FDA Label