Vyfemla

Product NDC: 57297-875
11-digit product format: 572970875
Labeler code: 57297
Product ID: 57297-875_acb1dea2-0653-45fa-bf1f-38cab18a81bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone and ethinyl estradiol
Dosage form: KIT
Labeler: LUPIN LIMITED
Application: ANDA201886
Marketing category: ANDA
Marketing start: 2013-12-23
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2017-12-31
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	57297-875		D	Discontinued by firm		2026-07-31
excluded package	package	57297-875	57297-875-13	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
A201886-001	VYFEMLA	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET / ORAL-28	AB		2013-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201886-001	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	A201886-001	VYFEMLA	0.035MG;0.4MG	TABLET / ORAL-28	AB		2013-09-26	`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	A201886-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vyfemla	NORETHINDRONE AND ETHINYL ESTRADIOL	Lupin Pharmaceuticals, Inc.	175ce5c4-d332-4c97-a0b8-10821dc813ef	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201886 application number: ANDA201886

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57297-875-13	2024-12-09	C162847	48780-1	9d75b9d0-6d9f-f424-e053-dadaa90a57ce	Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg
57297-875-13	2020-01-31	C162847	48780-1	9d75b9d0-6d9f-f424-e053-dadaa90a57ce	Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg	LUPIN LIMITED	2016-05-12	HUMAN PRESCRIPTION DRUG LABEL	1