Protopic
Protopic(tacrolimus) Ointment 0.03%Ointment 0.1% FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USE
Approved
Approval ID
51218de3-dabc-4972-9c5b-750c8b1d8083
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2022
Manufacturers
FDA
LEO Pharma Inc
DUNS: 832692615
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 Code50222-211
Application NumberNDA050777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (2)
TACROLIMUSActive
Quantity: 1 mg in 1 g
Code: WM0HAQ4WNM
Classification: ACTIM
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
Tacrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50222-203
Application NumberNDA050777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (8)
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PROPYLENE CARBONATEInactive
Code: 8D08K3S51E
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
TACROLIMUSActive
Quantity: 0.3 mg in 1 g
Code: WM0HAQ4WNM
Classification: ACTIM