BionaFem

Product NDC: 69452-243
Requested package NDC: 69452-243-60
11-digit product format: 694520243
Labeler code: 69452
Product ID: 69452-243_1a5852b7-0cfc-47f0-8948-de298f91ce02
Type: HUMAN OTC DRUG
Nonproprietary name: Levonorgestrel
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA207044
Marketing category: ANDA
Marketing start: 2019-04-14
Marketing end: 0000-00-00
Substance: LEVONORGESTREL
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	69452-243	69452-243-60	D	Discontinued by firm		2026-08-10

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 · 12 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…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A207044-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2016-03-25

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207044-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2016-03-25	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SheWise	LEVONORGESTREL	GLENMARK THERAPEUTICS INC., USA	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	2026-07-15	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044
Levonorgestrel	LEVONORGESTREL	GLENMARK THERAPEUTICS INC., USA	07567b80-d8a1-41c0-95e4-33afa584bbc4	2026-07-15	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044
Levonorgestrel	LEVONORGESTREL	YYBA Corp	49008f10-8a70-3c08-e063-6294a90a44a3	2026-02-03	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044
PostDay One-Step	LEVONORGESTREL	Home Health Brands, LLC	01c8c95c-6fbe-4068-915d-74418a6bb570	2025-04-23	Warnings	Exact identifier application applno (ANDA): 207044 application number: ANDA207044

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5W7SIA7YZW	LEVONORGESTREL	797-63-7	LEVONORGESTREL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-243-60	69452024360	1 BLISTER PACK in 1 CARTON (69452-243-60) > 1 TABLET in 1 BLISTER PACK	1 blister pack	2019-04-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BionaFem - Bionpharma Inc. \| Glenmark Pharmaceuticals Limited	Bionpharma Inc. \| Glenmark Pharmaceuticals Limited	2019-04-12	HUMAN OTC DRUG LABEL	1