Home NDC 79929-009 Norgestimate and ethinyl estradiol
Product NDC 79929-009
11-digit product format 799290009
Labeler code 79929
Product ID 79929-009_16bd96e5-1150-09e4-e063-6294a90a138d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norgestimate and ethinyl estradiol
Dosage form KIT
Labeler Naari Pte Limited
Application ANDA200383
Marketing category ANDA
Marketing start 2022-12-31
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Norgestimate and ethinyl estradiol
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240128 Internal RxNorm lookup 406396 Internal RxNorm lookup 687424 Internal RxNorm lookup 748797 Internal RxNorm lookup 749784 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79929-009-07 Norgestimate and ethinyl estradiol 3 in 1 CARTON KIT 3 5 79929-009-07 Norgestimate and ethinyl estradiol 1 in 1 CARTON KIT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79929-009 NORGESTIMATE AND ETHINYL ESTRADIOL KIT [NAARI PTE LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20240516_b936a6fb-27ed-44de-9199-8c656bcd366e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 79929-009-07 79929000907 3 CARTON in 1 CARTON (79929-009-07) / 1 KIT in 1 CARTON 3 carton 2022-12-31 0000-00-00 No No Current