Aygestin

Product NDC: 51285-424
Requested package NDC: 51285-424-10
11-digit product format: 512850424
Labeler code: 51285
Product ID: 51285-424_66c98489-8489-4b74-970a-cf86da8110b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norethindrone Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Teva Women's Health, Inc.
Application: ANDA075951
Marketing category: ANDA
Marketing start: 2003-06-12
Marketing end: 0000-00-00
Substance: NORETHINDRONE ACETATE
Active strength: 5 mg/1
Pharmacologic classes: Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51285-424	51285-424-10	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075951-001	NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075951-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075951-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	RS	2001-05-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075951-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075951-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075951-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075951-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075951-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075951-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075951-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075951-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075951-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075951-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075951-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075951-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075951-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075951-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075951-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075951-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075951-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075951-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075951-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075951-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075951-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075951-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075951-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075951-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075951-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075951-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075951-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075951-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075951-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075951-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075951-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075951-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075951-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075951-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075951-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075951-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075951-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075951-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075951-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075951-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51285-424-10	EA - Each	51285-424	014ea00c-51f0-43b4-a950-e2cd8fbd110a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NORETHINDRONE ACETATE	ACTIVE INGREDIENT	9S44LIC7OJ	AYGESTIN (NORETHINDRONE ACETATE) TABLET [TEVA WOMEN'S HEALTH, INC.]	5
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	AYGESTIN (NORETHINDRONE ACETATE) TABLET [TEVA WOMEN'S HEALTH, INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	AYGESTIN (NORETHINDRONE ACETATE) TABLET [TEVA WOMEN'S HEALTH, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AYGESTIN (NORETHINDRONE ACETATE) TABLET [TEVA WOMEN'S HEALTH, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AYGESTIN (NORETHINDRONE ACETATE) TABLET [TEVA WOMEN'S HEALTH, INC.]	5

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norethindrone Acetate	NORETHINDRONE ACETATE	Golden State Medical Supply, Inc.	2bb29135-6e9b-a9e2-e063-6394a90ae9e4	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075951 application number: ANDA075951
Norethindrone Acetate	NORETHINDRONE ACETATE	Teva Pharmaceuticals USA, Inc.	f73f9807-4af6-4faa-ba9a-656a47a4c5e0	2022-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075951 application number: ANDA075951

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9S44LIC7OJ	NORETHINDRONE ACETATE	51-98-9	NORETHINDRONE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51285-424-10	51285042410	50 TABLET in 1 BOTTLE (51285-424-10)	50 tablet	2003-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AYGESTIN ® (norethindrone acetate tablets, USP)	Teva Women's Health LLC	2015-10-31	HUMAN PRESCRIPTION DRUG LABEL	11