FDA.reportPublic FDA data

Norethindrone and ethinyl estradiol

Product NDC
60505-4901
11-digit product format
605054901
Labeler code
60505
Product ID
60505-4901_5cad8bf6-5bb8-5186-e063-6394a90ad158
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone and ethinyl estradiol
Dosage form
KIT
Labeler
Apotex Corp.
Application
ANDA206864
Marketing category
ANDA
Marketing start
2026-10-10
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206864-001NORETHINDRONE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE0.035MG;1MGTABLET / ORAL-28AB2017-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A206864-001AB

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28c2088c7a36db…
2026-09-14 22:38:342026-08A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-2884e616aacf4f…
2026-08-18 06:07:402026-07A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206864-001NORETHINDRONE AND ETHINYL ESTRADIOL0.035MG;1MGTABLET / ORAL-28AB2017-04-283a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-10-28 04:53 UTC2022-10A206864-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206864-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206864-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206864-001AB1a50c72e98297…

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
Norethindrone and ethinyl estradiol
Listing expiration
2027-12-31

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone and ethinyl estradiolNORETHINDRONE AND ETHINYL ESTRADIOLNaari Pte Limited9bd9119e-a874-41e2-ac58-b7f0d155d2fb2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206864
application number: ANDA206864

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4901-8605054901083 BLISTER PACK in 1 CARTON (60505-4901-8) / 1 KIT in 1 BLISTER PACK (60505-4901-2) 3 blister pack2026-10-10NoNoCurrent