Cyproheptadine Hydrochloride
CYPROHEPTADINE HYDROCHLORIDE TABLETS USPRx only
Approved
Approval ID
99fb821a-fe33-4468-9026-9729a8deff08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Bayshore Pharmaceuticals LLC
DUNS: 968737416
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 Code76385-130
Application NumberANDA206676
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyproheptadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2020
FDA Product Classification
INGREDIENTS (5)
CYPROHEPTADINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NJ82J0F8QC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT