Tri-Previfem

Product NDC
0603-7663
11-digit product format
006037663
Labeler code
0603
Product ID
0603-7663_407b729e-68c2-4357-82da-496470d9fe67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Par Pharmaceutical
Application
ANDA076335
Marketing category
ANDA
Marketing start
2004-03-26
Marketing end
2019-12-31
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0603-7663DDiscontinued by firm2026-10-05
excluded productproduct0603-7663DDiscontinued by firm2026-10-05
excluded packagepackage0603-76630603-7663-17DDiscontinued by firm2026-10-05
excluded packagepackage0603-76630603-7663-17DDiscontinued by firm2026-10-05

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-7663-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-7663-17d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-7663-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-7663-17f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-7663-172ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-7663-172ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-7663-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-7663-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-7663-17cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-7663-17cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-7663-17cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-7663-17cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-7663-17302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-7663-17302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-7663-17ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-7663-17ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-7663-170efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-7663-170efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-7663-17ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-7663-17ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-7663-17367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-7663-17367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-7663-17557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-7663-17557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076335-001TRI-PREVIFEMETHINYL ESTRADIOL; NORGESTIMATE0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2004-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2004-03-263f01610625f2…
2019-09-15 20:21 UTC2019-09A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2004-03-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2004-03-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076335-001TRI-PREVIFEM0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-282004-03-26f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076335-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076335-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076335-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076335-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-7663-01EA - Each0603-7663b921e1c5-b45f-4237-b210-db101f91642012015-05-05
0603-7663-17EA - Each0603-766380de8baa-301c-4ca5-bd1e-5e62a280e66d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
NORGESTIMATEACTIVE MOIETYC291HFX4DYPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12