CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride Tablets, USP
Approved
Approval ID
ccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CYPROHEPTADINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1076
Application NumberANDA208938
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYPROHEPTADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2022
FDA Product Classification
INGREDIENTS (5)
CYPROHEPTADINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NJ82J0F8QC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT