Home NDC 50090-1478 ALYACEN 7/7/7
Product NDC 50090-1478
11-digit product format 500901478
Labeler code 50090
Product ID 50090-1478_77e539de-3fb5-4da2-bdc3-79ccbd4232da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone and ethinyl estradiol
Dosage form KIT
Labeler A-S Medication Solutions
Application ANDA091636
Marketing category ANDA
Marketing start 2012-01-19
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2022-12-31
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 A091636-001 ALYACEN 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,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 A091636-001 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 A091636-001 ALYACEN 7/7/7 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,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 A091636-001 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 ALYACEN 1/35 NORETHINDRONE AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA 5c02b4d3-1e2f-439a-ae45-02304ee190d1 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091636 application number: ANDA091636
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-1478-0 2023-02-07 C162847 48780-1 f386c649-ab98-0266-e053-dadaa90a7c1a ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) 50090-1478-0 2023-01-30 C162847 48780-1 f386c649-ab98-0266-e053-dadaa90a7c1a ALYACEN 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg)
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-1478-0 50090147800 1 KIT in 1 KIT (50090-1478-0) 1 kit 2014-11-28 0000-00-00 No No Current