Home NDC 50090-1395-0 VIORELE
Product NDC 50090-1395
Requested package NDC 50090-1395-0
11-digit product format 500901395
Labeler code 50090
Product ID 50090-1395_fb1ff52e-d5ff-4ef2-9d1e-7dab6b047318
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol
Dosage form KIT
Labeler A-S Medication Solutions
Application ANDA091346
Marketing category ANDA
Marketing start 2012-04-04
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50090-1395 50090-1395-0 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A091346-001 VIORELE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091346-001 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 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base VIORELE
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248310 Internal RxNorm lookup 249357 Internal RxNorm lookup 748797 Internal RxNorm lookup 759743 Internal RxNorm lookup 1252016 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 50090-1395-0 VIORELE 1 in 1 KIT KIT 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1395 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] 16 Current NDC, Legacy NDC, 1 package rows 20240516_6422dcc3-959a-4590-9ca8-9dcb58e68253.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 50090-1395-0 50090139500 1 KIT in 1 KIT (50090-1395-0) 1 kit 2014-11-28 0000-00-00 No No Current