Home NDC 52544-236 Jevantique Lo
Product NDC 52544-236
11-digit product format 525440236
Labeler code 52544
Product ID 52544-236_17980177-8438-4344-a928-221bd8bdef7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA021065
Marketing category NDA
Marketing start 2015-11-09
Marketing end 2019-11-30
Substance NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Active strength 1 mg/1; ug/1
Pharmacologic classes Progesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52544-236-31 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52544-236-31 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52544-236-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52544-236-31 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52544-236-31 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52544-236-31 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52544-236-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52544-236-31 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52544-236-31 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52544-236-31 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52544-236-31 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52544-236-31 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021065-001 FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-01-14 N021065-002 FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N021065-001 FEMHRT 0.0025MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021065-002 FEMHRT 0.005MG;1MG TABLET / ORAL RLD 1999-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021065-002 FEMHRT 0.005MG;1MG TABLET / ORAL RLD 1999-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL AB 2005-01-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021065-001 FEMHRT 0.0025MG;0.5MG TABLET / ORAL RLD 2005-01-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021065-002 FEMHRT 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-10-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1 NORETHINDRONE ACETATE ACTIVE INGREDIENT 9S44LIC7OJ JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1 NORETHINDRONE ACTIVE MOIETY T18F433X4S JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ JEVANTIQUE LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [ACTAVIS PHARMA, INC.] 1