MedPath
FDA Product

Tacrolimus

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Tacrolimus

63629-8723

Regulatory Information

63629-8723

ANDA065461

C73584

June 20, 2019

USA

These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral useInitial U.S. Approval: 1994

HUMAN PRESCRIPTION DRUG LABEL

103

Company Information

171714327

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2208 (100 MPA.S)

Code: B1QE5P712K

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

TACROLIMUS

Quantity: 1 mg in 1 1

Code: WM0HAQ4WNM

Class Code: ACTIM

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

TACROLIMUS ANHYDROUS

Code: Y5L2157C4J

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