ALYACEN 1/35

Product NDC: 68462-394
11-digit product format: 684620394
Labeler code: 68462
Product ID: 68462-394_9d4967e6-42df-4468-99a6-9b57499497d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone and ethinyl estradiol
Dosage form: KIT
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA091634
Marketing category: ANDA
Marketing start: 2012-01-19
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 ndc (product): 68462-394
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

Additional Listing Data#

Finished product: Yes
Brand name base: ALYACEN 1/35
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310463	Internal RxNorm lookup
312033	Internal RxNorm lookup
392662	Internal RxNorm lookup
748797	Internal RxNorm lookup
749852	Internal RxNorm lookup
749858	Internal RxNorm lookup
1242786	Internal RxNorm lookup
1242787	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5c02b4d3-1e2f-439a-ae45-02304ee190d1	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-394-29	ALYACEN 1/35	3 in 1 CARTON	KIT	3		10
68462-394-84	ALYACEN 1/35	1 in 1 BLISTER PACK	KIT	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-394-29	EA - Each	68462-394	e3a65ebb-1bc5-457a-a6fc-f63c58485975	1	2012-07-24
68462-394-84	EA - Each	68462-394	eed416a9-37f7-49d0-8490-46c2821f5cfa	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
NORETHINDRONE	ACTIVE INGREDIENT	T18F433X4S	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-394	ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]	9	Current NDC, Legacy NDC, 2 package rows	20240104_5c02b4d3-1e2f-439a-ae45-02304ee190d1.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	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
749858	{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
1242786	ALYACEN 1/35 28 Day Pack	PSN	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
749858	Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
748797	inert 1 MG Oral Tablet	PSN	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
312033	norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet	PSN	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
312033	ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet	SCD	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
748797	inert ingredients 1 MG Oral Tablet	SCD	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
1242786	Alyacen 1/35 28-Day Kit	SY	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
312033	ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet	SY	a45ee86e-69ca-49a5-8990-5dde52d4a522	14
1242786	{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 1/35]	BPCK	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
1242787	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 7/7/7]	BPCK	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
749858	{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
749852	{7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
1242786	ALYACEN 1/35 28 Day Pack	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
1242787	ALYACEN 7/7/7 28 Day Pack	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
749852	Eth estra-Noreth 0.035-0.5 MG (7) Oral Tablet / Eth estra-Noreth 0.035-0.75 MG (7) Oral Tablet / Eth estra-Noreth 0.035-1 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
749858	Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
748797	inert 1 MG Oral Tablet	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
310463	norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
392662	norethindrone 0.75 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
312033	norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet	PSN	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
310463	ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet	SCD	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
392662	ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet	SCD	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
312033	ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet	SCD	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
748797	inert ingredients 1 MG Oral Tablet	SCD	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
1242786	Alyacen 1/35 28-Day Kit	SY	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
1242787	Alyacen 7/7/7 28-Day Kit	SY	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
1242787	Alyacen 7/7/7 Kit	SY	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
310463	ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet	SY	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
392662	ethinyl estradiol 35 MCG / norethindrone 0.75 MG Oral Tablet	SY	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
312033	ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet	SY	5c02b4d3-1e2f-439a-ae45-02304ee190d1	10
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
1242786	{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Alyacen 1/35]	BPCK	fa32e05b-c86d-4743-aee5-be3fc515152b	2
749858	{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	fa32e05b-c86d-4743-aee5-be3fc515152b	2
1242786	ALYACEN 1/35 28 Day Pack	PSN	fa32e05b-c86d-4743-aee5-be3fc515152b	2
749858	Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	fa32e05b-c86d-4743-aee5-be3fc515152b	2
748797	inert 1 MG Oral Tablet	PSN	fa32e05b-c86d-4743-aee5-be3fc515152b	2
312033	norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet	PSN	fa32e05b-c86d-4743-aee5-be3fc515152b	2
312033	ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet	SCD	fa32e05b-c86d-4743-aee5-be3fc515152b	2
748797	inert ingredients 1 MG Oral Tablet	SCD	fa32e05b-c86d-4743-aee5-be3fc515152b	2
1242786	Alyacen 1/35 28-Day Kit	SY	fa32e05b-c86d-4743-aee5-be3fc515152b	2
312033	ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet	SY	fa32e05b-c86d-4743-aee5-be3fc515152b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-394-29	68462039429	3 BLISTER PACK in 1 CARTON (68462-394-29) / 1 KIT in 1 BLISTER PACK (68462-394-84)	3 blister pack	2012-01-19	0000-00-00	No	No	Current
68462-394-84	68462039484	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALYACEN 7/7/7	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-31	HUMAN PRESCRIPTION DRUG LABEL	10
ALYACEN 1/35(Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg)	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
ALYACEN 1/35	A-S Medication Solutions	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	14
ALYACEN 1/35	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	4
ALYACEN 1/35	REMEDYREPACK INC.	2018-05-21	HUMAN PRESCRIPTION DRUG LABEL	1