Home NDC 17478-261-06 Norgestimate and Ethinyl Estradiol
Product NDC 17478-261
Requested package NDC 17478-261-06
11-digit product format 174780261
Labeler code 17478
Product ID 17478-261_4abe9d31-c125-427d-b056-9bb321eb19fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norgestimate and Ethinyl Estradiol
Dosage form KIT
Route ORAL
Labeler Akorn
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 2023-12-31
Current FDA listing Historical FDA.report record 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17478-261-06 17478026106 6 CARTON in 1 CARTON (17478-261-06) > 1 BLISTER PACK in 1 CARTON (17478-261-28) > 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 6 carton 2016-11-15 0000-00-00 No No Current