Tacrolimus

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 use Initial U.S. Approval: 1994

Approved

Approval ID

5f742224-618e-4f4c-bdec-7693be99c697

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2023

Manufacturers

FDA

Mylan Institutional Inc.

DUNS: 039615992

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tacrolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51079-028

Application NumberANDA090596

Product Classification

Marketing Category

C73584

Generic Name

Tacrolimus

Product Specifications

Route of AdministrationORAL

Effective DateDecember 27, 2023

FDA Product Classification

INGREDIENTS (20)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

D&C RED NO. 33Inactive

Code: 9DBA0SBB0L

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

TACROLIMUSActive

Quantity: 5 mg in 1 1

Code: WM0HAQ4WNM

Classification: ACTIM

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Tacrolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51079-817

Application NumberANDA090596

Product Classification

Marketing Category

C73584

Generic Name

Tacrolimus

Product Specifications

Route of AdministrationORAL

Effective DateDecember 27, 2023

FDA Product Classification

INGREDIENTS (19)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

TACROLIMUSActive

Quantity: 0.5 mg in 1 1

Code: WM0HAQ4WNM

Classification: ACTIM

Tacrolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51079-818

Application NumberANDA090596

Product Classification

Marketing Category

C73584

Generic Name

Tacrolimus

Product Specifications

Route of AdministrationORAL

Effective DateDecember 27, 2023

FDA Product Classification

INGREDIENTS (19)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

TACROLIMUSActive

Quantity: 1 mg in 1 1

Code: WM0HAQ4WNM

Classification: ACTIM

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

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Tacrolimus

Products 3

Tacrolimus

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Tacrolimus

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Tacrolimus

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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