Norgestimate and Ethinyl Estradiol

Product NDC: 71205-170
11-digit product format: 712050170
Labeler code: 71205
Product ID: 71205-170_fc4f50b4-4325-477f-93b6-41c76cb1d67f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norgestimate and Ethinyl Estradiol
Dosage form: KIT
Labeler: Proficient Rx LP
Application: ANDA200383
Marketing category: ANDA
Marketing start: 2016-11-15
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
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	71205-170		D	Discontinued by firm		2026-07-31
excluded package	package	71205-170	71205-170-28	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
A200383-001	NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2015-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200383-001	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	A200383-001	NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2015-04-07	`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	A200383-001	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
Norgestimate and ethinyl estradiol	NORGESTIMATE AND ETHINYL ESTRADIOL	Naari Pte Limited	b936a6fb-27ed-44de-9199-8c656bcd366e	2024-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200383 application number: ANDA200383

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-170-28	EA - Each	71205-170	028b8f3b-853c-4d4b-9a26-dccdb72490c3	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-170	NORGESTIMATE AND ETHINYL ESTRADIOL KIT [PROFICIENT RX LP]	2	Legacy NDC	20191016_4c5034e5-f247-4961-870d-60c67149d51a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-170-28	71205017028	1 BLISTER PACK in 1 CARTON (71205-170-28) > 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK	1 blister pack	2018-12-01	0000-00-00	No	No	Current