Norgestimate and Ethinyl Estradiol

Product NDC: 53002-1733
Requested package NDC: 53002-1733-3
11-digit product format: 530021733
Labeler code: 53002
Product ID: 53002-1733_c986a93e-72e7-4cd1-aa61-c29df95d7f58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norgestimate and Ethinyl Estradiol
Dosage form: KIT
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA200494
Marketing category: ANDA
Marketing start: 2011-06-17
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1733	53002-1733-3	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 · 6 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
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1733	53002-1733-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1733	53002-1733-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1733	53002-1733-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1733	53002-1733-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1733	53002-1733-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1733	53002-1733-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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
A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200494-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2011-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2011-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2011-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2011-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200494-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	RS	2011-06-17	`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	A200494-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200494-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200494-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200494-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200494-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200494-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200494-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200494-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200494-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200494-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200494-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200494-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200494-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200494-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200494-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200494-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200494-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200494-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200494-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200494-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200494-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200494-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200494-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200494-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200494-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200494-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200494-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200494-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200494-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200494-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200494-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200494-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200494-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200494-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200494-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200494-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200494-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200494-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200494-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200494-001	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
Norgestimate and Ethinyl Estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	Glenmark Pharmaceuticals Inc., USA	8b247e46-203e-4f5b-b5a7-cbd57341c735	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200494 application number: ANDA200494
Norgestimate and Ethinyl Estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	A-S Medication Solutions	6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600	2023-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200494 application number: ANDA200494
Norgestimate and Ethinyl Estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	Proficient Rx LP	4a159dcd-8af4-4e59-8f46-7b0fe5c22807	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200494 application number: ANDA200494

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
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
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
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
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
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
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
53002-1733-1	2025-01-30	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-3	2025-01-30	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-6	2025-01-30	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-1	2023-06-07	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-3	2023-06-07	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-6	2023-06-07	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-1	2023-01-30	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-3	2023-01-30	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-6	2023-01-30	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-1	2020-12-15	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-3	2020-12-15	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-6	2020-12-15	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-1	2020-01-31	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-3	2020-01-31	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1733-6	2020-01-31	C162847	48780-1	9d75b9cf-e10b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1733-1	Norgestimate and Ethinyl Estradiol	1 in 1 PACKAGE	KIT	1	3
53002-1733-1	Norgestimate and Ethinyl Estradiol	1 in 1 BLISTER PACK	KIT	1	3
53002-1733-3	Norgestimate and Ethinyl Estradiol	1 in 1 BLISTER PACK	KIT	1	3
53002-1733-3	Norgestimate and Ethinyl Estradiol	3 in 1 PACKAGE	KIT	3	3
53002-1733-6	Norgestimate and Ethinyl Estradiol	1 in 1 BLISTER PACK	KIT	1	3
53002-1733-6	Norgestimate and Ethinyl Estradiol	6 in 1 PACKAGE	KIT	6	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1733	NORGESTIMATE AND ETHINYL ESTRADIOL KIT [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 6 package rows	20230609_63e95a36-47e5-4f62-b390-65937744f7f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
406396	norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet	PSN	63e95a36-47e5-4f62-b390-65937744f7f5	3
406396	ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet	SCD	63e95a36-47e5-4f62-b390-65937744f7f5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1733-3	53002173303	3 BLISTER PACK in 1 PACKAGE (53002-1733-3) > 1 KIT in 1 BLISTER PACK	3 blister pack	2017-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Norgestimate and Ethinyl Estradiol	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	3