Home NDC 50090-3394-1 Norgestimate and Ethinyl Estradiol
Product NDC 50090-3394
Requested package NDC 50090-3394-1
11-digit product format 500903394
Labeler code 50090
Product ID 50090-3394_c15b757b-ab46-4e48-8376-4cd5adf571cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norgestimate and Ethinyl Estradiol
Dosage form KIT
Labeler A-S Medication Solutions
Application ANDA200538
Marketing category ANDA
Marketing start 2012-04-06
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200538-001 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 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200538-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2012-04-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-3394-1 2023-02-07 C162847 48780-1 f386c64a-027d-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 50090-3394-1 2023-01-30 C162847 48780-1 f386c64a-027d-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-3394-1 50090339401 1 KIT in 1 KIT (50090-3394-1) 1 kit 2021-01-11 0000-00-00 No No Current