Tacrolimus
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . TACROLIMUS capsules, for oral useInitial U.S. Approval: 1994
Approved
Approval ID
0a557ca9-b1a1-cf8f-a317-e4d8d4d6e60f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2021
Manufacturers
FDA
Biocon Pharma Inc.
DUNS: 080000063
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 Code70377-014
Application NumberANDA212297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (13)
TACROLIMUSActive
Quantity: 0.5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Tacrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-015
Application NumberANDA212297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (12)
TACROLIMUSActive
Quantity: 1 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Tacrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-016
Application NumberANDA212297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (12)
TACROLIMUSActive
Quantity: 5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Hypromellose 2910 (6 Mpa.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Potassium HydroxideInactive
Code: WZH3C48M4T
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT