Previfem

Product NDC: 53002-2191
Requested package NDC: 53002-2191-6
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#

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	53002-2191	53002-2191-6	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2191-6	53002219106	6 BLISTER PACK in 1 POUCH (53002-2191-6) > 1 KIT in 1 BLISTER PACK	6 blister pack	2019-01-02	0000-00-00	No	No	Current