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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-422
Application NumberANDA211688
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 17, 2021
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-421
Application NumberANDA211688
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 17, 2021
FDA Product Classification
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