ALYACEN 1/35

Product NDC: 53002-1780
11-digit product format: 530021780
Labeler code: 53002
Product ID: 53002-1780_543ba0d2-618a-4784-bfa1-0a88cd996b17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone and ethinyl estradiol
Dosage form: KIT
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA091634
Marketing category: ANDA
Marketing start: 2012-01-19
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-1780		I	Inactivated by FDA	2026-08-03
excluded package	package	53002-1780	53002-1780-1	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-1780	53002-1780-3	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-1780	53002-1780-6	I	Inactivated by FDA	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 · 8 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
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	53002-1780		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1780	53002-1780-6	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1780	53002-1780-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1780	53002-1780-1	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	53002-1780		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1780	53002-1780-6	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1780	53002-1780-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1780	53002-1780-1	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
f6ac5560-6d3b-d281-41d2-adc50d283c20	Product name	3	20170228
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-1780-1	2025-01-30	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-3	2025-01-30	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-6	2025-01-30	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-1	2023-06-07	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-3	2023-06-07	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-6	2023-06-07	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-1	2023-01-30	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-3	2023-01-30	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)
53002-1780-6	2023-01-30	C162847	48780-1	f386c64a-4529-0266-e053-dadaa90a7c1a	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)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1780-1	ALYACEN 1/35	1 in 1 BLISTER PACK	KIT	1	4
53002-1780-3	ALYACEN 1/35	1 in 1 BLISTER PACK	KIT	1	4
53002-1780-3	ALYACEN 1/35	3 in 1 POUCH	KIT	3	4
53002-1780-6	ALYACEN 1/35	6 in 1 POUCH	KIT	6	4
53002-1780-6	ALYACEN 1/35	1 in 1 BLISTER PACK	KIT	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1780	ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.]	4	Legacy NDC, 5 package rows	20230609_5c4c8517-b81a-4716-be70-1b2b7e7dd146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1242786	{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 1/35]	BPCK	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
749858	{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
1242786	ALYACEN 1/35 28 Day Pack	PSN	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
749858	Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
748797	inert 1 MG Oral Tablet	PSN	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
312033	norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet	PSN	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
312033	ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet	SCD	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
748797	inert ingredients 1 MG Oral Tablet	SCD	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
1242786	Alyacen 1/35 28-Day Kit	SY	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4
312033	ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet	SY	5c4c8517-b81a-4716-be70-1b2b7e7dd146	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1780-1	53002178001	1 KIT in 1 BLISTER PACK (53002-1780-1)	1 kit	2019-01-01	0000-00-00	No	No	Current
53002-1780-3	53002178003	3 BLISTER PACK in 1 POUCH (53002-1780-3) > 1 KIT in 1 BLISTER PACK	3 blister pack	2019-01-01	0000-00-00	No	No	Current
53002-1780-6	53002178006	6 BLISTER PACK in 1 POUCH (53002-1780-6) > 1 KIT in 1 BLISTER PACK	6 blister pack	2019-01-01	0000-00-00	No	No	Current