Home NDC 50090-1477 ALYACEN 1/35
Product NDC 50090-1477
11-digit product format 500901477
Labeler code 50090
Product ID 50090-1477_0d2b87a8-0799-4985-af1d-1aab0085e39d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone and ethinyl estradiol
Dosage form KIT
Labeler A-S Medication Solutions
Application ANDA091634
Marketing category ANDA
Marketing start 2012-01-19
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 A091634-001 ALYACEN 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET / ORAL-28 AB 2012-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091634-001 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 A091634-001 ALYACEN 1/35 0.035MG;1MG TABLET / ORAL-28 AB 2012-01-19 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 A091634-001 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ALYACEN 1/35
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312033 Internal RxNorm lookup 748797 Internal RxNorm lookup 749858 Internal RxNorm lookup 1242786 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-1477-0 ALYACEN 1/35 1 in 1 KIT KIT 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1477 ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] 14 Current NDC, Legacy NDC, 1 package rows 20240511_a45ee86e-69ca-49a5-8990-5dde52d4a522.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 50090-1477-0 50090147700 1 KIT in 1 KIT (50090-1477-0) 1 kit 2014-11-28 0000-00-00 No No Current