Previfem

Product NDC: 70518-2010
11-digit product format: 705182010
Labeler code: 70518
Product ID: 70518-2010_c59a4beb-796b-2cac-e053-2a95a90a5ae3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norgestimate and ethinyl estradiol
Dosage form: KIT
Labeler: REMEDYREPACK INC.
Application: ANDA090794
Marketing category: ANDA
Marketing start: 2019-04-11
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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	70518-2010		D	Discontinued by firm		2026-07-31
excluded package	package	70518-2010	70518-2010-0	D	Discontinued by firm		2026-07-31

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.

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
2026-08-01 22:54:32	2026-06	A090794-001	ESTARYLLA	0.035MG;0.25MG	TABLET / ORAL-28	AB		2013-01-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090794-001	AB	1	`a50c72e98297…`

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 · 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2010-0	2023-03-08	C162847	48780-1	f386c649-c008-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Previfem ® safely and effectively. See full prescribing information for Previfem ® . Previfem ® (NORGESTIMATE and ETHINYL ESTRADIOL tablets) for oral use Initial U.S. Approval: 1989
70518-2010-0	2023-01-30	C162847	48780-1	f386c649-c008-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Previfem ® safely and effectively. See full prescribing information for Previfem ® . Previfem ® (NORGESTIMATE and ETHINYL ESTRADIOL tablets) for oral use Initial U.S. Approval: 1989

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2010-0	70518201000	6 CARTON in 1 CARTON (70518-2010-0) > 1 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK	6 carton	2019-04-11	0000-00-00	No	No	Current