ALYACEN 1/35

Product NDC: 70518-1212
11-digit product format: 705181212
Labeler code: 70518
Product ID: 70518-1212_6cbe3c0b-b35f-1b3e-e053-2a91aa0a2e25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone and ethinyl estradiol
Dosage form: KIT
Labeler: REMEDYREPACK INC.
Application: ANDA091634
Marketing category: ANDA
Marketing start: 2018-05-16
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#

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	70518-1212		D	Discontinued by firm		2026-08-03
excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 18 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	70518-1212		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1212	70518-1212-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`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
A091634-001	ALYACEN 1/35	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET / ORAL-28	AB		2012-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091634-001	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	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091634-001	ALYACEN 1/35	0.035MG;1MG	TABLET / ORAL-28	AB	2012-01-19	`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	A091634-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091634-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091634-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091634-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091634-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091634-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091634-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091634-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091634-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091634-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091634-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091634-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091634-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091634-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091634-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091634-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091634-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091634-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091634-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091634-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091634-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091634-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091634-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091634-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091634-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091634-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091634-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091634-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091634-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091634-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091634-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091634-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091634-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091634-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091634-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091634-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091634-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091634-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091634-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091634-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALYACEN 1/35	NORETHINDRONE AND ETHINYL ESTRADIOL	Glenmark Pharmaceuticals Inc., USA	5c02b4d3-1e2f-439a-ae45-02304ee190d1	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091634 application number: ANDA091634
ALYACEN 1/35	NORETHINDRONE AND ETHINYL ESTRADIOL	Proficient Rx LP	fa32e05b-c86d-4743-aee5-be3fc515152b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091634 application number: ANDA091634
ALYACEN 1/35	NORETHINDRONE AND ETHINYL ESTRADIOL	A-S Medication Solutions	a45ee86e-69ca-49a5-8990-5dde52d4a522	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091634 application number: ANDA091634

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-1212-0	2020-03-26	C162847	48780-1	9d75b9d0-5224-f424-e053-dadaa90a57ce	ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg)
70518-1212-0	2020-01-31	C162847	48780-1	9d75b9d0-5224-f424-e053-dadaa90a57ce	ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg)