Tacrolimus
Tacrolimus Ointment, 0.03% and 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE
Approved
Approval ID
80e6817a-9b1e-4f0f-e053-2a91aa0a3d15
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2021
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tacrolimus
PRODUCT DETAILS
NDC Product Code16729-422
Application NumberANDA211688
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 17, 2021
Generic NameTacrolimus
INGREDIENTS (6)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PROPYLENE CARBONATEInactive
Code: 8D08K3S51E
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
TACROLIMUSActive
Quantity: 1 mg in 1 g
Code: WM0HAQ4WNM
Classification: ACTIM
Tacrolimus
PRODUCT DETAILS
NDC Product Code16729-421
Application NumberANDA211688
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 17, 2021
Generic NameTacrolimus
INGREDIENTS (6)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PROPYLENE CARBONATEInactive
Code: 8D08K3S51E
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
TACROLIMUSActive
Quantity: 0.3 mg in 1 g
Code: WM0HAQ4WNM
Classification: ACTIM