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CYPROHEPTADINE HYDROCHLORIDE

ANDA

CYPROHEPTADINE HYDROCHLORIDE | A040537 | MOUNTAIN LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from CorePharma, LLC FDA-2002-P-0001 · 6 docket documents CorePharma LLC requests that the FDA assign reference listed drug status to a currently marketed and approved Cyproheptadine Hydrochloride Tablets 4 mg product, asserting that Merck's Periactin, the existing RLD, is no longer available in the market as evidenced by Merck's discontinuation notice.	Other	2014-09-29	Denied	CorePharma, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.0662

per ea

Lowest NADAC/Unit

$0.0662

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00115175701CYPROHEPTADINE 4 MG TABLET	$0.0662	EA	Generic	—	2026-06-17
50268020115CYPROHEPTADINE 4 MG TABLET	$0.0662	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPACYPROHEPTADINE HYDROCHLORIDE

DMF 32931978

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveCYPROHEPTADINE HYDROCHLORIDE

DMF 173642004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 4MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 30, 2003

No patent or exclusivity listings for this strength.