Home NDC 79929-019 DROSPIRENONE AND ETHINYL ESTRADIOL
Product NDC 79929-019
11-digit product format 799290019
Labeler code 79929
Product ID 79929-019_16ab0359-9249-a092-e063-6394a90af576
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DROSPIRENONE AND ETHINYL ESTRADIOL
Dosage form KIT
Labeler Naari Pte. Limited
Application ANDA207245
Marketing category ANDA
Marketing start 2023-04-05
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 A207245-001 DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 AB 2016-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207245-001 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 A207245-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 AB 2016-11-22 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 A207245-001 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base DROSPIRENONE AND ETHINYL ESTRADIOL
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284207 Internal RxNorm lookup 748797 Internal RxNorm lookup 748800 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 79929-019-07 DROSPIRENONE AND ETHINYL ESTRADIOL 3 in 1 POUCH KIT 3 3 79929-019-07 DROSPIRENONE AND ETHINYL ESTRADIOL 1 in 1 BLISTER PACK KIT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79929-019 DROSPIRENONE AND ETHINYL ESTRADIOL KIT [NAARI PTE. LIMITED] 3 Current NDC, 2 package rows 20240424_d96f0dd8-4eb9-42f7-ab5e-b5515dcf73d6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 79929-019-07 79929001907 3 BLISTER PACK in 1 POUCH (79929-019-07) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK 3 blister pack 2023-04-05 No No Current