PROMETHEGAN
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only
Approved
Approval ID
5f079815-f48b-8b21-2130-7f791d967c9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0526
Application NumberANDA040428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationRECTAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
FAT, HARDInactive
Code: 8334LX7S21
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB
promethazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0536
Application NumberANDA040428
Product Classification
M
Marketing Category
C73584
G
Generic Name
promethazine hydrochloride
Product Specifications
Route of AdministrationRECTAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
FAT, HARDInactive
Code: 8334LX7S21
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB