FDA.reportPublic FDA data

Drospirenone and Ethinyl Estradiol

Product NDC
59746-763
Requested package NDC
59746-763-42
11-digit product format
597460763
Labeler code
59746
Product ID
59746-763_4219f41b-ed0d-4b19-86ee-5a5470b4d5b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Drospirenone and ethinyl estradiol
Dosage form
KIT
Labeler
Jubilant Cadista Pharmaceuticals Inc
Application
ANDA209423
Marketing category
ANDA
Marketing start
2018-11-30
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59746-76359746-763-42DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A209423-001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22

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 22:38:342026-08A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORALAB2017-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209423-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.02MGTABLET / ORAL2017-12-22f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209423-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209423-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209423-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209423-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209423-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209423-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209423-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209423-001AB1ea99ee380514…

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
59746-763-42EA - Each59746-763aca03642-bc80-4212-b53c-f6891b669e3612019-05-02
59746-763-43EA - Each59746-7631ef8e1fa-5f57-4747-938d-01aaf5592b6112019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-763-42597460763421 BLISTER PACK in 1 PACKAGE (59746-763-42) > 1 KIT in 1 BLISTER PACK1 blister pack2018-11-300000-00-00NoNoCurrent