Home NDC 50090-2191 Kelnor 1/35
Product NDC 50090-2191
11-digit product format 500902191
Labeler code 50090
Product ID 50090-2191_a5db2a67-56a5-4c67-a1fc-12ad662b4193
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethynodiol Diacetate and Ethinyl Estradiol
Dosage form KIT
Labeler A-S Medication Solutions
Application ANDA076785
Marketing category ANDA
Marketing start 2005-06-20
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 43 .
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 A076785-001 KELNOR ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076785-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076785-001 KELNOR 0.035MG;1MG TABLET / ORAL-28 AB 2005-05-23 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Kelnor 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 310228 Internal RxNorm lookup 748797 Internal RxNorm lookup 748804 Internal RxNorm lookup 753483 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 50090-2191-0 Kelnor 1/35 1 in 1 KIT KIT 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2191 KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] 12 Current NDC, Legacy NDC, 1 package rows 20230208_cfa297a6-1cc7-4751-b8ea-0e57965f1ca9.zip
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.
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 50090-2191-0 50090219100 1 KIT in 1 KIT (50090-2191-0) 1 kit 2015-10-26 0000-00-00 No No Current