QUARTETTE

Product NDC: 51285-431
Requested package NDC: 51285-431-65
11-digit product format: 512850431
Labeler code: 51285
Product ID: 51285-431_978c6012-75e6-438a-af3b-67bdf1ce1a88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol
Dosage form: KIT
Labeler: Teva Women's Health, Inc.
Application: NDA204061
Marketing category: NDA
Marketing start: 2013-07-25
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51285-431	51285-431-65	D	Discontinued by firm		2026-10-05

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51285-431-65	EA - Each	51285-431	53629d1b-4e09-47a2-aad8-f942e779a6eb	1	2013-08-02
51285-431-87	EA - Each	51285-431	a5565c09-4b40-43c3-b5b3-53458132ed9e	1	2017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	QUARTETTE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51285-431-65	51285043165	1 POUCH in 1 CARTON (51285-431-65) > 1 KIT in 1 POUCH	1 pouch	2013-07-25	0000-00-00	No	No	Current