Home NDC 65862-935 Aurovela 1.5/30
Product NDC 65862-935
11-digit product format 658620935
Labeler code 65862
Product ID 65862-935_07926174-446c-43dc-9db1-db8b78432645
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA207581
Marketing category ANDA
Marketing start 2017-06-26
Substance ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength 30; 1.5 ug/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 A207581-001 AUROVELA 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET / ORAL-21 AB 2017-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207581-001 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 A207581-001 AUROVELA 1.5/30 0.03MG;1.5MG TABLET / ORAL-21 AB 2017-06-26 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 A207581-001 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 Aurovela 1.5/30 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Aurobindo Pharma Limited b146e49c-a0fc-4f3d-9ad6-99e8257fa139 2023-11-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207581 application number: ANDA207581 ndc (product): 65862-935
Additional Listing Data#
Finished product Yes
Brand name base Aurovela 1.5/30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE ACETATE 30 ug/1 ETHINYL ESTRADIOL 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9S44LIC7OJ Internal UNII lookup 423D2T571U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359022 Internal RxNorm lookup 1359028 Internal RxNorm lookup 1928007 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 65862-935-54 Aurovela 1.5/30 1 in 1 POUCH TABLET 1 12 65862-935-54 Aurovela 1.5/30 5 in 1 CARTON TABLET 5 12 65862-935-74 Aurovela 1.5/30 1 in 1 POUCH TABLET 1 12 65862-935-74 Aurovela 1.5/30 3 in 1 CARTON TABLET 3 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-935 AUROVELA 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [AUROBINDO PHARMA LIMITED] 12 Current NDC, Legacy NDC, 4 package rows 20231123_b146e49c-a0fc-4f3d-9ad6-99e8257fa139.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 65862-935-54 65862093554 5 POUCH in 1 CARTON (65862-935-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK 5 pouch 2017-06-26 0000-00-00 No No Current 65862-935-74 65862093574 3 POUCH in 1 CARTON (65862-935-74) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK 3 pouch 2017-06-26 0000-00-00 No No Current