Pimecrolimus
These highlights do not include all the information needed to use PIMECROLIMUS safely and effectively. See full prescribing information for PIMECROLIMUS.PIMECROLIMUS cream, for topical useInitial U.S. Approval: 2001
Approved
Approval ID
6601e43e-ce7d-446a-8568-8e7b24b86f06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2020
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pimecrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-112
Application NumberNDA021302
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pimecrolimus
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (11)
PimecrolimusActive
Quantity: 10 mg in 1 g
Code: 7KYV510875
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CETOSTEARYL SULFATEInactive
Code: 7ZBS06BH4B
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Pimecrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-111
Application NumberNDA021302
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pimecrolimus
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (11)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CETOSTEARYL SULFATEInactive
Code: 7ZBS06BH4B
Classification: IACT
PimecrolimusActive
Quantity: 10 mg in 1 g
Code: 7KYV510875
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
Pimecrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-110
Application NumberNDA021302
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pimecrolimus
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (11)
PimecrolimusActive
Quantity: 10 mg in 1 g
Code: 7KYV510875
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
SODIUM CETOSTEARYL SULFATEInactive
Code: 7ZBS06BH4B
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT