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NORETHINDRONE ACETATE

ANDA

NORETHINDRONE ACETATE | A075951 | BARR LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Warner Chilcott - Citizen Petition FDA-2008-P-0587 · 3 docket documents Warner Chilcott Company, Inc. submitted this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any ANDA relying on Loestrin 24 Fe Tablets (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg with ferrous fumarate, NDA 21-871) as the re	505(q)	2008-12-11	Granted	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.2988

per ea

Lowest NADAC/Unit

$0.2988

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00555021110NORETHINDRONE 5 MG TABLET	$0.2988	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 NC)

Lowest Price

$34.10

Highest Price

$88.51

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
51407-0599-50NORETHINDRONE ACETATE 5MG TAB	$34.10	NC	Golden State Medical Supply, Inc.	02/19/2027
00555-0211-10NORETHINDRONE ACETATE 5MG TAB	$88.51	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs4 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGNORETHINDRONE ACETATE

DMF 20331972

ASPEN OSS BVNORETHINDRONE ACETATE

DMF 101851993

LUPIN LTDNORETHINDRONE ACETATE USP

DMF 225072009

VALDEPHARMNORETHINDRONE ACETATE

DMF 249132011

NAARI PTE LTDNORETHINDRONE ACETATE

DMF 360632021

STEROID SPANORETHINDRONE ACETATE

DMF 434722026

SYNTEX USA INCInactiveNORETHINDRONE ACETATE

DMF 10841967

ROUSSEL CORPInactiveNORETHINDRONE ACETATE

DMF 18461971

MITSUBISHI CHEMICAL INDUSTRIES LTDInactiveNORETHINDRONE ACETATE, BULK

DMF 29841977

NOVO NORDISK ASInactiveNORETHINDRONE ACETATE

DMF 63531986

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 25, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 25, 2001

No patent or exclusivity listings for this strength.