Previfem

Product NDC: 53002-2191
Requested package NDC: 53002-2191-1
11-digit product format: 530022191
Labeler code: 53002
Product ID: 53002-2191_96aecc0d-ee78-474b-8c14-46bc51011167
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norgestimate and ethinyl estradiol
Dosage form: KIT
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA090794
Marketing category: ANDA
Marketing start: 2019-01-02
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	53002-2191	53002-2191-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53002-2191	53002-2191-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53002-2191	53002-2191-1	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
A090794-001	ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET / ORAL-28	AB		2013-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090794-001	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	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB	2013-01-30	`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	A090794-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090794-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090794-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090794-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090794-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090794-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090794-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090794-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090794-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090794-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090794-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090794-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090794-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090794-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090794-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090794-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090794-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090794-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090794-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090794-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090794-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090794-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090794-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090794-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090794-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090794-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090794-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090794-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090794-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090794-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090794-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090794-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090794-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090794-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090794-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090794-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090794-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090794-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090794-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090794-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Proficient Rx LP	7acde5ef-f457-4c47-897b-d048194c7d7e	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794
Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	e0b07fb6-8dbd-4e5d-b589-5191a1dc02ae	2024-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794
Norgestimate and Ethinyl Estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	AvKARE	a3c0c983-7ec7-244a-e053-2995a90adbe4	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794
Estarylla	NORGESTIMATE AND ETHINYL ESTRADIOL	Xiromed, LLC.	7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f8	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090794 application number: ANDA090794

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2191-1	53002219101	1 KIT in 1 BLISTER PACK (53002-2191-1)	1 kit	2019-01-02	0000-00-00	No	No	Current