DROSPIRENONE AND ETHINYL ESTRADIOL

Product NDC
68180-902
Requested package NDC
68180-902-73
11-digit product format
681800902
Labeler code
68180
Product ID
68180-902_8117529f-3b99-4e22-90dc-6ad5ec8e9e31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DROSPIRENONE AND ETHINYL ESTRADIOL
Dosage form
KIT
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA201663
Marketing category
ANDA
Marketing start
2021-02-07
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage68180-90268180-902-73DDiscontinued 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
A201663-001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201663-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-1884e616aacf4f…
2026-08-18 06:07:402026-07A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201663-001DROSPIRENONE AND ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28AB2012-12-18f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A201663-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A201663-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201663-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201663-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201663-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201663-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201663-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201663-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201663-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201663-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201663-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201663-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201663-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201663-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201663-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201663-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201663-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201663-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201663-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201663-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201663-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201663-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201663-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201663-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201663-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201663-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201663-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201663-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201663-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201663-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201663-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201663-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201663-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201663-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201663-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201663-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201663-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201663-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201663-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201663-001AB1f41ea6bd6efb…

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
68180-902-11EA - Each68180-90201349e23-0e95-4eda-bf2b-88e2f4208c5612013-02-13
68180-902-13EA - Each68180-9024eb06ebc-4c31-4640-b1ba-55ee397926c212013-02-13
68180-902-71EA - Each68180-90271ede554-2252-4f93-a2ff-2909607c389812021-05-05
68180-902-73EA - Each68180-9023ca32e5d-3787-4509-afed-f1fde40bc26012021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
DROSPIRENONEACTIVE MOIETYN295J34A25DROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]6

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201663
application number: ANDA201663
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201663
application number: ANDA201663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-902-73681800902733 BLISTER PACK in 1 CARTON (68180-902-73) > 1 KIT in 1 BLISTER PACK (68180-902-71) 3 blister pack2021-02-070000-00-00NoNoCurrent