norethindrone acetate and ethinyl estradiol and ferrous fumarate

Product NDC: 0430-0539
11-digit product format: 004300539
Labeler code: 0430
Product ID: 0430-0539_185f3a87-1c64-4025-877d-4f4aad6f774f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Dosage form: KIT
Labeler: Warner Chilcott (US), LLC
Application: NDA204426
Marketing category: NDA
Marketing start: 2016-05-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0430-0539		D	Discontinued by firm	2026-08-17
excluded package	package	0430-0539	0430-0539-50	D	Discontinued by firm	2026-08-17
excluded package	package	0430-0539	0430-0539-95	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0430-0539-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0430-0539-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0430-0539-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0430-0539-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0430-0539-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0430-0539-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0430-0539-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0430-0539-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0430-0539-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0430-0539-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0430-0539-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0430-0539-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0430-0539-95	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0430-0539-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0430-0539-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0430-0539-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0430-0539-95	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0430-0539-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0430-0539-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0430-0539-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0430-0539-95	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0430-0539-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0430-0539-95	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0430-0539-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N204426-001	TAYTULLA	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204426-001	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	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL		RLD, RS	2013-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL		RLD, RS	2013-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL		RLD, RS	2013-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL		RLD, RS	2013-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL		RLD, RS	2013-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204426-001	TAYTULLA	0.02MG;1MG	CAPSULE / ORAL	AB	RLD, RS	2013-04-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N204426-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204426-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204426-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204426-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204426-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204426-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204426-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204426-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204426-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204426-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204426-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204426-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204426-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204426-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204426-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204426-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204426-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204426-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204426-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204426-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204426-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204426-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204426-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204426-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204426-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204426-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204426-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204426-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204426-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204426-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204426-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204426-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204426-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204426-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204426-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204426-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204426-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204426-001	6652880	2020-03-29	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204426-001	6652880	2020-03-29	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204426-001	6652880	2020-03-29	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204426-001	6652880	2020-03-29	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204426-001	6652880	2020-03-29	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204426-001	6652880	2020-03-29	Drug product	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Taytulla	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE	Allergan, Inc.	2fa8e8dc-f7b0-429a-b554-0e3c4291c92c	2024-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204426 application number: NDA204426

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
norethindrone acetate and ethinyl estradiol and ferrous fumarate	Warner Chilcott (US), LLC \| Catalent Pharma Solutions	2013-05-30	HUMAN PRESCRIPTION DRUG LABEL	2