Home NDC 50090-6374 Kurvelo
Product NDC 50090-6374
11-digit product format 500906374
Labeler code 50090
Product ID 50090-6374_1529b388-2aad-440d-8b01-a40291c834ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levonorgestrel and ethinyl estradiol
Dosage form KIT
Labeler A-S Medication Solutions
Application ANDA091408
Marketing category ANDA
Marketing start 2021-02-07
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 A091408-001 KURVELO ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091408-001 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 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091408-001 KURVELO 0.03MG;0.15MG TABLET / ORAL-28 AB 2012-10-17 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 Kurvelo
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 238019 Internal RxNorm lookup 748797 Internal RxNorm lookup 748878 Internal RxNorm lookup 1356074 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 50090-6374-0 Kurvelo 1 in 1 CARTON KIT 1 1 68180-841-74 Kurvelo 21 in 1 BLISTER PACK TABLET 21 0.15 mg 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6374 KURVELO (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] 1 Current NDC, 2 package rows 20230427_51e4270a-1b91-4ff8-9a50-ffe49204b6b4.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 Sample Exclude flag Status 50090-6374-0 50090637400 1 KIT in 1 CARTON (50090-6374-0) * 21 TABLET in 1 BLISTER PACK (68180-841-74) * 7 TABLET in 1 BLISTER PACK (68180-842-74) 1 kit 2023-02-20 No No Current 68180-841-74 68180084174 21 in 1 BLISTER PACK Historical