AUBRA

Product NDC: 50102-120
11-digit product format: 501020120
Labeler code: 50102
Product ID: 50102-120_406de71d-930b-4271-b1f0-95871cbcae5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levonorgestrel and Ethinyl Estradiol
Dosage form: KIT
Labeler: Afaxys Pharma, LLC
Application: ANDA200245
Marketing category: ANDA
Marketing start: 2013-10-15
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50102-120		D	Discontinued by firm	2026-10-02
excluded package	package	50102-120	50102-120-03	D	Discontinued by firm	2026-10-02
excluded package	package	50102-120	50102-120-48	D	Discontinued by firm	2026-10-02

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50102-120-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50102-120-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50102-120-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50102-120-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50102-120-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50102-120-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50102-120-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50102-120-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50102-120-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50102-120-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50102-120-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50102-120-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50102-120-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50102-120-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50102-120-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50102-120-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50102-120-48	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50102-120-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50102-120-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50102-120-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50102-120-48	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50102-120-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50102-120-48	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50102-120-03	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET / ORAL-28	AB1		2013-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200245-001	AB1

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	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200245-001	LEVONORGESTREL AND ETHINYL ESTRADIOL	0.02MG;0.1MG	TABLET / ORAL-28	AB1	2013-10-09	`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	A200245-001	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200245-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200245-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200245-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200245-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200245-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200245-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200245-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200245-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200245-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200245-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200245-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200245-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200245-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200245-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200245-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200245-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200245-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200245-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200245-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200245-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200245-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200245-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200245-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200245-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200245-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200245-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200245-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200245-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200245-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200245-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200245-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200245-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200245-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200245-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200245-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200245-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200245-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200245-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200245-001	AB1	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50102-120-03	2023-02-17	Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)
50102-120-48	2023-02-17	Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)
50102-120-03	2023-01-30	Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)
50102-120-48	2023-01-30	Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50102-120-00	EA - Each	50102-120	d9bee6d9-aa9d-4898-93de-438dae2bb869	1	2022-06-06
50102-120-01	EA - Each	50102-120	8b796782-496f-4ed0-b025-66127b0fc3f9	1	2013-11-04
50102-120-03	EA - Each	50102-120	c2265cdf-ed8f-437d-9e4b-312af0119f71	1	2017-09-11
50102-120-10	EA - Each	50102-120	5c1fb698-e254-4b92-8ed9-eb87d3604632	1	2017-09-11
50102-120-48	EA - Each	50102-120	8a66d499-33ea-4443-a859-d114a3240255	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]	4

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVONORGESTREL AND ETHINYL ESTRADIOL	LEVONORGESTREL AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	c3c00dc0-8834-45fb-9f5b-810a98cef59d	2022-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200245 application number: ANDA200245

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50102-120-03	50102012003	3 PACKAGE in 1 CARTON (50102-120-03) > 1 BLISTER PACK in 1 PACKAGE (50102-120-10) > 1 KIT in 1 BLISTER PACK (50102-120-00)	3 package	2017-08-14	0000-00-00	No	No	Current
50102-120-48	50102012048	48 CARTON in 1 CASE (50102-120-48) > 1 BLISTER PACK in 1 CARTON (50102-120-01) > 1 KIT in 1 BLISTER PACK (50102-120-00)	48 carton	2013-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)	Afaxys Pharma, LLC \| Mylan Laboratories Limited	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	12
Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	4