CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride Tablets, USP
Approved
Approval ID
d7d778a4-f016-4e42-85b3-b3fc0c578106
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
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 Code55700-700
Application NumberANDA208938
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYPROHEPTADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2018
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CYPROHEPTADINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NJ82J0F8QC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT