Necon

Product NDC: 51862-318
Requested package NDC: 51862-318-03
11-digit product format: 518620318
Labeler code: 51862
Product ID: 51862-318_ae1416de-d609-437c-ab05-e2f574f8e155
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norethindrone and Ethinyl Estradiol
Dosage form: KIT
Labeler: Mayne Pharma Inc.
Application: ANDA072695
Marketing category: ANDA
Marketing start: 2016-07-18
Marketing end: 2022-04-30
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
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	51862-318	51862-318-03	D	Discontinued by firm		2026-08-03

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 · 12 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A072695-001	NORTREL 0.5/35-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET / ORAL-28	AB		1992-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072695-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072695-001	NORTREL 0.5/35-28	0.035MG;0.5MG	TABLET / ORAL-28	AB	1992-02-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072695-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072695-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072695-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072695-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072695-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072695-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072695-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072695-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072695-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072695-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072695-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072695-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072695-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072695-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072695-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072695-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072695-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072695-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072695-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072695-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072695-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072695-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072695-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072695-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072695-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072695-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072695-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072695-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072695-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072695-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072695-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072695-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072695-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072695-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072695-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072695-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072695-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072695-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072695-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072695-001	AB	1	`cb3db0bc1861…`

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
Nortrel 28 Day	NORETHINDRONE AND ETHINYL ESTRADIOL	A-S Medication Solutions	33b895e4-b467-41b1-a812-8068cc5bb93e	2024-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072695 application number: ANDA072695
Nortrel 28 Day	NORETHINDRONE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	140c50d6-c931-423a-9aa0-526eae7ab93c	2021-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072695 application number: ANDA072695

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-318-03	51862031803	3 POUCH in 1 CARTON (51862-318-03) > 1 BLISTER PACK in 1 POUCH (51862-318-01) > 1 KIT in 1 BLISTER PACK	3 pouch	2016-07-18	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Necon ® (norethindrone and ethinyl estradiol tablets USP)	Mayne Pharma Inc. \| Teva Pharmaceuticals USA, Inc.	2017-09-30	HUMAN PRESCRIPTION DRUG LABEL	8