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
NDC Product Code70377-014
Application NumberANDA212297
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 7, 2021
Generic NameTacrolimus
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
NDC Product Code70377-015
Application NumberANDA212297
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 7, 2021
Generic NameTacrolimus
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
NDC Product Code70377-016
Application NumberANDA212297
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 7, 2021
Generic NameTacrolimus
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