Home NDC 50090-2097 Ashlyna
Product NDC 50090-2097
11-digit product format 500902097
Labeler code 50090
Product ID 50090-2097_17d299fd-e568-4f6f-989a-cbf0e47c3bf6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol
Dosage form KIT
Labeler A-S Medication Solutions
Application ANDA203163
Marketing category ANDA
Marketing start 2015-02-23
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 A203163-001 ASHLYNA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203163-001 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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ashlyna LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL A-S Medication Solutions 2004a53d-3f62-4c33-813a-94b1567fe465 2026-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203163 application number: ANDA203163 ndc (product): 50090-2097 Ashlyna LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA 407a9f63-9abf-4886-864a-d3dd0e429762 2026-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203163 application number: ANDA203163
Additional Listing Data#
Finished product Yes
Brand name base Ashlyna
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238019 Internal RxNorm lookup 248310 Internal RxNorm lookup 749761 Internal RxNorm lookup 1603861 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 50090-2097-0 Ashlyna 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 50090-2097 ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] 14 Current NDC, Legacy NDC, 1 package rows 20240110_2004a53d-3f62-4c33-813a-94b1567fe465.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 50090-2097-0 50090209700 1 KIT in 1 KIT (50090-2097-0) 1 kit 2015-10-12 0000-00-00 No No Current