Loestrin

Product NDC: 51285-126
11-digit product format: 512850126
Labeler code: 51285
Product ID: 51285-126_966ca14a-7af3-40d1-9859-466784a6fd81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Dosage form: KIT
Labeler: Teva Women's Health, Inc.
Application: ANDA076081
Marketing category: ANDA
Marketing start: 2015-07-22
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51285-126		D	Discontinued by firm		2026-09-14
excluded package	package	51285-126	51285-126-98	D	Discontinued by firm		2026-09-14

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 · 24 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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`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	51285-126-98	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076081-001	JUNEL FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET / ORAL-28	AB		2003-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076081-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076081-001	JUNEL FE 1/20	0.02MG;1MG	TABLET / ORAL-28	AB	2003-09-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076081-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076081-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076081-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076081-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076081-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076081-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076081-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076081-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076081-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076081-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076081-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076081-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076081-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076081-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076081-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076081-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076081-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076081-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076081-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076081-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076081-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076081-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076081-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076081-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076081-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076081-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076081-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076081-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076081-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076081-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076081-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076081-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076081-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076081-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076081-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076081-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076081-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076081-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076081-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076081-001	AB	1	`f41ea6bd6efb…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51285-126-98	EA - Each	51285-126	7807f8a0-f3d4-4933-a136-f2740b09ef14	1	2015-03-03

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Junel Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	PD-Rx Pharmaceuticals, Inc.	93a2f8c9-3550-42ec-8f76-3ac9badf4bb2	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081
Junel Fe 1/20	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE	Preferred Pharmaceuticals Inc.	75bb0024-8f1a-4036-9acd-006ea430f3b7	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081
Junel Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Bryant Ranch Prepack	13d7768b-ee41-46b0-93f4-5e8170dd338d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081
Junel 21 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8b82ad14-580c-4145-b825-dce849f95363	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081
Loestrin Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Teva Women's Health LLC	f29ebcb5-7e65-4092-bfaa-f5ec026fc255	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081
Junel Fe 28 Day	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	A-S Medication Solutions	421b8cf7-119f-495a-b10a-bd864e87ab5a	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076081 application number: ANDA076081