Rivelsa

Product NDC: 0093-6031
11-digit product format: 000936031
Labeler code: 0093
Product ID: 0093-6031_c0a84adf-aa60-4da1-be5a-6e7f9cc03df2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol
Dosage form: KIT
Labeler: Teva Pharmaceuticals USA, Inc.
Application: NDA204061
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-04-03
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
N204061-001	QUARTETTE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204061-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204061-001	8415332	2029-03-11		Drug product	2013-04-16

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204061-001	QUARTETTE	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET / ORAL	AB	RLD, RS	2013-03-28	`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	N204061-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204061-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204061-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204061-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204061-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204061-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204061-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204061-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204061-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204061-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204061-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204061-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204061-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204061-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204061-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204061-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204061-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204061-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204061-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204061-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204061-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204061-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204061-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204061-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204061-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204061-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204061-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204061-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204061-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204061-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204061-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204061-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204061-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204061-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204061-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204061-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204061-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204061-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204061-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204061-001	AB	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204061-001	8415332	2029-03-11		Drug product	2013-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204061-001	8450299	2025-10-07	U-1		2013-06-11	`782e0a99824c…`

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: Rivelsa
Listing expiration: 2027-12-31

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
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
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
f713a022-3e1c-4035-bc91-62131bc80b42	Product name	2	20190125
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
741e98f2-ac6c-4d80-9ca8-c663c171ba1d	Product name	1	20161121
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
cc765024-f257-4c67-b780-c356aadd6980	Product name	3	20150902
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
5a9b579b-8431-5b3a-2ba4-86556704f873	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d03a75af-b11b-673b-268b-318050d0b3bd	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508
e5ccd419-1745-560a-1e25-c6e3941c710a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-6031-82	Rivelsa	2 in 1 CARTON	KIT	2		13
0093-6031-91	Rivelsa	1 in 1 POUCH	KIT	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-6031-82	EA - Each	0093-6031	262db3f3-1913-4ab0-9b3d-a4c178aef32f	1	2017-05-03
0093-6031-91	EA - Each	0093-6031	44ee58ab-561a-4b25-9198-ea4021021fbb	1	2017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-6031	RIVELSA (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20241027_822e56c6-562f-4299-bf4f-eaee0c0f2b7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1876397	{7 (ethinyl estradiol 0.01 MG Oral Tablet) / 42 (ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) } Pack [Rivelsa 91 Day]	BPCK	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1373503	{7 (ethinyl estradiol 0.01 MG Oral Tablet) / 42 (ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) } Pack	GPCK	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1373503	Eth estra 0.01 MG (7) Oral Tablet / Eth estra-Levonorgest 0.02-0.15 MG (42) Oral Tablet / Eth estra-Levonorgest 0.025-0.15 MG (21) Oral Tablet / Eth estra-Levonorgest 0.03-0.15 MG (21) Oral Tablet 3 Month Pack	PSN	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
248310	ethinyl estradiol 0.01 MG Oral Tablet	PSN	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1373501	ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet	PSN	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1373502	ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet	PSN	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
238019	levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet	PSN	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1876397	Rivelsa 91 Day Pack	PSN	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
248310	ethinyl estradiol 0.01 MG Oral Tablet	SCD	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1373501	ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet	SCD	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1373502	ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet	SCD	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
238019	ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet	SCD	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
248310	ethinyl estradiol 10 MCG Oral Tablet	SY	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13
1876397	Rivelsa 91 Day Pack	SY	822e56c6-562f-4299-bf4f-eaee0c0f2b7a	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-6031-82	00093603182	2 POUCH in 1 CARTON (0093-6031-82) / 1 KIT in 1 POUCH (0093-6031-91)	2 pouch	2017-04-03	0000-00-00	No	No	Current
0093-6031-91	00093603191	1 in 1 POUCH						Historical