Necon

Product NDC: 51862-318
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	51862-318		D	Discontinued by firm		2026-08-03
excluded package	package	51862-318	51862-318-03	D	Discontinued by firm		2026-08-03

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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