MedPath

Cyproheptadine Hydrochloride

Approved
Approval ID

76f11fdd-6089-47a1-b1a1-ee1bf490dc97

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 30, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-1332
Application NumberANDA040537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyproheptadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2011
FDA Product Classification

INGREDIENTS (5)

CYPROHEPTADINE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NJ82J0F8QC
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Cyproheptadine Hydrochloride - FDA Drug Approval Details