Home NDC 17478-260-06 Norgestimate and Ethinyl Estradiol
Product NDC 17478-260
Requested package NDC 17478-260-06
11-digit product format 174780260
Labeler code 17478
Product ID 17478-260_4abe9d31-c125-427d-b056-9bb321eb19fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norgestimate and Ethinyl Estradiol
Dosage form KIT
Route ORAL
Labeler Akorn
Application ANDA200384
Marketing category ANDA
Marketing start 2016-11-15
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2023-12-31
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 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 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200384-001 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 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200384-001 NORGESTIMATE AND ETHINYL ESTRADIOL 0.035MG;0.25MG TABLET / ORAL-28 AB 2015-04-07 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.
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 · 1 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 17478-260-06 17478026006 6 CARTON in 1 CARTON (17478-260-06) > 1 BLISTER PACK in 1 CARTON (17478-260-28) > 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK 6 carton 2016-11-15 0000-00-00 No No Current