Details of the Drug Formulations

General Information of Drug (ID: DMZ7XNQ)

• Drug Name: Tacrolimus Drug Info
• Synonyms: Advagraf; Fujimycin; Graceptor; Modigraf; Prograf; Protopic; Protopy; Tacarolimus; Tsukubaenolide; Tacrolimus anhydrous; FK 506; FK5; FK506; FR 900506; FR900506; K506; L 679934; Advagraf (TN); FR-900506; Fk-506; L-679934; LCP-Tacro; Prograf (TN); Protopic (TN); Tacrolimus (INN); Tacrolimus (Prograf); Tacrolimus (anhydrous); (-)-FK 506; 15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(23H)-tetrone; 8-DEETHYL-8-[BUT-3-ENYL]-ASCOMYCIN

Indication

Disease Entry	ICD 11	Status	REF
Graft-versus-host disease	4B24	Approved	[1]
Hepatosplenic T-cell lymphoma		Approved	[1]
Kidney transplant rejection	NE84	Approved	[1]
Large granular lymphocytic leukemia	2A90.1	Approved	[1]
Leukemia		Approved	[1]
Lupus nephritis	4A40.0Y	Approved	[1]
MALT lymphoma		Approved	[1]
Myeloproliferative neoplasm	2A20	Approved	[1]
Nodal marginal zone lymphoma	2A85.0	Approved	[1]
Organ transplant rejection	NE84	Approved	[2]
Primary cutaneous peripheral T-cell lymphoma not otherwise specified		Approved	[1]
Recurrent adult burkitt lymphoma	2A85.6	Approved	[1]
Small intestine lymphoma		Approved	[1]
Splenic marginal zone lymphoma		Approved	[1]
Testicular lymphoma		Approved	[1]
Ocular allergy	4A81	Phase 3	[2]
Classic Hodgkin lymphoma		Investigative	[1]

• Therapeutic Class: Immunosuppressive Agents
• Cross-matching ID:
  PubChem CID: 445643
  ChEBI ID: CHEBI:61049
  CAS Number: 104987-11-3
  TTD ID: D06OMK
  VARIDT ID: DR00406
  INTEDE ID: DR1524
  ACDINA ID: D00648

Full List of Drug Formulations Containing This Drug

Tacrolimus 5 mg capsule

Company	Formulation ID	FDA Description
Mylan Pharamceuticals	F20610	Anhydrous lactose; D&c red no. 28; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; D&c red no. 33; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Gelatin; Hypromelloses; Shellac
Golden State Medical Supply	F20611	Anhydrous lactose; D&c red no. 28; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; D&c red no. 33; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Gelatin, unspecified; Hypromellose, unspecified; Shellac
Watson Laboratories	F20609	Anhydrous lactose; Fd&c red no. 40; Fd&c blue no. 1; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Fd&c red no. 3; Gelatin; Hypromelloses
Strides Shasun	F20616	D&c red no. 28; Lactose monohydrate; D&c yellow no. 10; Fd&c blue no. 1; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (5 mpa.s)
Accord Healthcare	F20614	Lactose monohydrate; Sodium lauryl sulfate; Magnesium stearate; Ferric oxide red; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (5 mpa.s)
Novartis Pharmaceuticals Corporation	F20612	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2208 (100 mpa.s); Shellac
Sandoz	F20613	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2208 (100 mpa.s); Shellac
American Health Packaging	F20615	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Titanium dioxide; Croscarmellose sodium; Gelatin, unspecified
Dr Reddy's Laboratories; Major Pharmaceuticals	F20617	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Titanium dioxide; Croscarmellose sodium; Gelatin
Bionpharma; Kremers Urban Pharmaceuticals Inc.; Panacea Biotec	F20607	Anhydrous lactose; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (5 mpa.s)
Ingenus Pharmaceuticals	F20608	Lactose monohydrate; Magnesium stearate; Croscarmellose sodium; Hypromellose 2910 (50 mpa.s)

Tacrolimus 0.5 mg capsule

Company	Formulation ID	FDA Description
Mylan Pharamceuticals	F20578	Anhydrous lactose; D&c red no. 28; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Gelatin; Hypromelloses; Shellac
Golden State Medical Supply	F20579	Anhydrous lactose; D&c red no. 28; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Gelatin, unspecified; Hypromellose, unspecified; Shellac
Strides Shasun	F20580	Lactose monohydrate; Fd&c red no. 40; Fd&c blue no. 1; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (5 mpa.s)
Accord Healthcare	F20583	Lactose monohydrate; Sodium lauryl sulfate; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (5 mpa.s)
Cardinal Health	F20585	Lactose monohydrate; Sodium lauryl sulfate; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromelloses
Novartis Pharmaceuticals Corporation	F20581	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2208 (100 mpa.s); Shellac
Sandoz	F20582	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2208 (100 mpa.s); Shellac
American Health Packaging	F20584	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin, unspecified
Dr Reddy's Laboratories; Major Pharmaceuticals	F20586	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin
Bionpharma; Kremers Urban Pharmaceuticals Inc.; Panacea Biotec	F20576	Anhydrous lactose; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (5 mpa.s)
Ingenus Pharmaceuticals	F20577	Lactose monohydrate; Magnesium stearate; Croscarmellose sodium; Hypromellose 2910 (50 mpa.s)

Tacrolimus 1 mg capsule

Company	Formulation ID	FDA Description
Aphena Pharma Solutions-Tennessee; Mylan Pharamceuticals	F20591	Anhydrous lactose; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Fd&c red no. 3; Silicon dioxide; Gelatin; Hypromelloses; Shellac
Cardinal Health; Golden State Medical Supply	F20592	Anhydrous lactose; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Fd&c red no. 3; Silicon dioxide; Gelatin, unspecified; Hypromellose, unspecified; Shellac
Strides Shasun	F20594	Lactose monohydrate; Fd&c blue no. 1; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (5 mpa.s)
A-S Medication Solutions; Accord Healthcare	F20597	Lactose monohydrate; Sodium lauryl sulfate; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (5 mpa.s)
Cardinal Health	F20604	Lactose monohydrate; Sodium lauryl sulfate; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromelloses
Major Pharmaceuticals	F20603	Lactose monohydrate; Sodium lauryl sulfate; Magnesium stearate; Titanium dioxide; Gelatin, unspecified; Hypromellose 2910 (5 mpa.s)
Novartis Pharmaceuticals Corporation	F20595	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2208 (100 mpa.s); Shellac
Sandoz	F20596	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2208 (100 mpa.s); Shellac
Cardinal Health; Kaiser Foundation Hospitals	F20601	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromelloses; Shellac
Cardinal Health	F20602	Lactose monohydrate; Butyl alcohol; Magnesium stearate; Ammonia; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2208 (100 mpa.s); Shellac
Bryant Ranch Prepack	F20589	Anhydrous lactose; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (5 mpa.s)
Bionpharma; Kremers Urban Pharmaceuticals Inc.; Panacea Biotec	F20593	Anhydrous lactose; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (5 mpa.s)
Rebel Distributors	F20598	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromelloses
American Health Packaging	F20599	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin, unspecified
Cardinal Health	F20600	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin; Hypromellose 2910 (6 mpa.s)
Cardinal Health; Dr Reddy's Laboratories	F20605	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Croscarmellose sodium; Gelatin
Ingenus Pharmaceuticals	F20590	Lactose monohydrate; Magnesium stearate; Croscarmellose sodium; Hypromellose 2910 (50 mpa.s)

Tacrolimus 0.75 mg tablet

Company	Formulation ID	FDA Description
Veloxis Pharmaceuticals	F20587	Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Tartaric acid; Poloxamer 188; Polyethylene glycol 6000; Dimethicone; Hypromelloses

Tacrolimus 1 mg tablet

Company	Formulation ID	FDA Description
Veloxis Pharmaceuticals	F20588	Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Tartaric acid; Poloxamer 188; Polyethylene glycol 6000; Dimethicone; Hypromelloses

Tacrolimus 4 mg tablet

Company	Formulation ID	FDA Description
Veloxis Pharmaceuticals	F20606	Lactose monohydrate; Butylated hydroxytoluene; Magnesium stearate; Tartaric acid; Poloxamer 188; Polyethylene glycol 6000; Dimethicone; Hypromelloses

References

• [1] Tacrolimus FDA Label
• [2] URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 6784).