Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium

Product NDC: 0781-4075
11-digit product format: 007814075
Labeler code: 0781
Product ID: 0781-4075_4f8e8c46-a43e-4b73-b4d2-63076f27113d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Dosage form: KIT
Labeler: Sandoz Inc
Application: NDA022532
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-10-12
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022532-001	BEYAZ	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022532-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022532-001	8617597	2030-02-08		Drug product	2014-01-29
N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15
N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15
N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15
N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB		2010-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022532-001	BEYAZ	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET / ORAL	AB	RLD, RS	2010-09-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022532-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022532-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022532-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022532-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022532-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022532-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022532-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022532-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022532-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022532-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022532-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022532-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022532-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022532-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022532-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022532-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022532-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022532-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022532-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022532-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022532-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022532-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022532-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022532-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022532-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022532-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022532-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022532-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022532-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022532-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022532-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022532-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022532-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022532-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022532-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022532-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022532-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022532-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022532-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022532-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 174 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022532-001	8617597	2030-02-08		Drug product	2014-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022532-001	11617751	2030-07-17	U-1	Drug product	2023-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022532-001	11617751	2030-07-17	U-3572	Drug product	2023-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022532-001	11617751	2030-07-17	U-3573	Drug product	2023-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022532-001	11617751	2030-07-17	U-3574	Drug product	2023-05-15	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1013626	Internal RxNorm lookup
1013628	Internal RxNorm lookup
1013629	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
58cd12d3-39b1-4375-b7e0-09ba2378a52b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
94cad6dc-cea3-446b-a918-06fd714373a6	Product name	1	20211018
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
89f15567-66a7-42ff-8abb-567b85d302d8	Product name	1	20190828
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-4075-15	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	3 in 1 CARTON	KIT	3		14
0781-4075-52	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	1 in 1 BLISTER PACK	KIT	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-4075-15	EA - Each	0781-4075	db0c01b5-770b-4c95-931c-d5eb9aea4154	1	2016-11-08
0781-4075-52	EA - Each	0781-4075	b1a3be2c-0e78-45ff-8fac-8dc6019b2027	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DROSPIRENONE	ACTIVE INGREDIENT	N295J34A25	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
LEVOMEFOLATE CALCIUM	ACTIVE INGREDIENT	A9R10K3F2F	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
DROSPIRENONE	ACTIVE MOIETY	N295J34A25	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
LEVOMEFOLIC ACID	ACTIVE MOIETY	8S95DH25XC	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
BETADEX	INACTIVE INGREDIENT	JV039JZZ3A	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-4075	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	14	Current NDC, Legacy NDC, 2 package rows	20241207_58cd12d3-39b1-4375-b7e0-09ba2378a52b.zip

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
Beyaz	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM	Bayer HealthCare Pharmaceuticals Inc.	8132454a-6135-4bac-b206-83a55eb8dbc6	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022532 application number: NDA022532
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM	Sandoz Inc	58cd12d3-39b1-4375-b7e0-09ba2378a52b	2023-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022532 application number: NDA022532 ndc (product): 0781-4075

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1013629	{24 (drospirenone 3 MG / ethinyl estradiol 0.02 MG / levomefolate calcium 0.451 MG Oral Tablet) / 4 (levomefolate calcium 0.451 MG Oral Tablet) } Pack	GPCK	58cd12d3-39b1-4375-b7e0-09ba2378a52b	14
1013629	Drospiren-Eth estra-Levomefol Ca 3-0.02-0.451 MG (24) Oral Tablet / Levomefol Ca 0.451 MG (4) Oral Tablet 28 Day Pack	PSN	58cd12d3-39b1-4375-b7e0-09ba2378a52b	14
1013626	drospirenone 3 MG / ethinyl estradiol 0.02 MG / levomefolate calcium 0.451 MG Oral Tablet	PSN	58cd12d3-39b1-4375-b7e0-09ba2378a52b	14
1013628	levomefolate calcium 0.451 MG Oral Tablet	PSN	58cd12d3-39b1-4375-b7e0-09ba2378a52b	14
1013626	drospirenone 3 MG / ethinyl estradiol 0.02 MG / levomefolate calcium 0.451 MG Oral Tablet	SCD	58cd12d3-39b1-4375-b7e0-09ba2378a52b	14
1013628	levomefolate calcium 0.451 MG Oral Tablet	SCD	58cd12d3-39b1-4375-b7e0-09ba2378a52b	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-4075-15	00781407515	3 BLISTER PACK in 1 CARTON (0781-4075-15) / 1 KIT in 1 BLISTER PACK (0781-4075-52)	3 blister pack	2016-10-12	0000-00-00	No	No	Current
0781-4075-52	00781407552	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Sandoz Inc \| Bayer HealthCare Pharmaceuticals Inc. \| Bayer Weimar GmbH und Co. KG \| Bayer AG \| Sharp Corporation	2023-05-19	HUMAN PRESCRIPTION DRUG LABEL	14