DROSPIRENONE AND ETHINYL ESTRADIOL

Product NDC: 67296-2286
11-digit product format: 672962286
Labeler code: 67296
Product ID: 67296-2286_57d1d72f-b7f6-49ca-e063-6294a90a5d7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DROSPIRENONE AND ETHINYL ESTRADIOL
Dosage form: KIT
Labeler: Redpharm Drug
Application: ANDA201663
Marketing category: ANDA
Marketing start: 2022-04-15
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB		2012-12-18

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201663-001	DROSPIRENONE AND ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	2012-12-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201663-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201663-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201663-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201663-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201663-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201663-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201663-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201663-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201663-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201663-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201663-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201663-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201663-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201663-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201663-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201663-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201663-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201663-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201663-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201663-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201663-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201663-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201663-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201663-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201663-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201663-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201663-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201663-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201663-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201663-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201663-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201663-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201663-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201663-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201663-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201663-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201663-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201663-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201663-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201663-001	AB	1	`f41ea6bd6efb…`

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: DROSPIRENONE AND ETHINYL ESTRADIOL
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
284207	Internal RxNorm lookup
748797	Internal RxNorm lookup
748800	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57d1d945-9fc9-4e79-e063-6294a90a738a	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE AND ETHINYL ESTRADIOL	Redpharm Drug	57d1d945-9fc9-4e79-e063-6294a90a738a	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201663 application number: ANDA201663 ndc (product): 67296-2286
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE AND ETHINYL ESTRADIOL	Lupin Pharmaceuticals, Inc.	a8955f3b-afc9-4ef0-8946-9c97ab5b2e05	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201663 application number: ANDA201663

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2286-3	67296228603	3 POUCH in 1 CARTON (67296-2286-3) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-912-74) * 7 TABLET in 1 BLISTER PACK (68180-913-74)	3 pouch	2022-04-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DROSPIRENONE AND ETHINYL ESTRADIOL - Redpharm Drug	Redpharm Drug	2026-07-30	HUMAN PRESCRIPTION DRUG LABEL	1