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CYPROHEPTADINE HYDROCHLORIDE

Cyproheptadine Hydrochloride Tablets, USP Rx only

Approved
Approval ID

1bfb14ad-b522-4ad6-8c9f-2d99dd0dce64

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 15, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code72162-2066
Application NumberANDA212491
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYPROHEPTADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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CYPROHEPTADINE HYDROCHLORIDE - FDA Drug Approval Details