SheWise

Product NDC: 72657-108
11-digit product format: 726570108
Labeler code: 72657
Product ID: 72657-108_88548851-6506-4cb2-8636-a30be9ee562e
Type: HUMAN OTC DRUG
Nonproprietary name: Levonorgestrel
Dosage form: TABLET
Route: ORAL
Labeler: GLENMARK THERAPEUTICS INC., USA
Application: ANDA207044
Marketing category: ANDA
Marketing start: 2022-07-29
Substance: LEVONORGESTREL
Active strength: 1.5 mg/1
Pharmacologic classes: Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	72657-108	72657-108-11	D	Discontinued by firm		2026-08-10

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: SheWise
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVONORGESTREL	1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5W7SIA7YZW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483325	Internal RxNorm lookup
2730936	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
7be13a7e-b4ff-4fe1-82a6-f9914596d72a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
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
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1d	Product name	1	20161121
cc765024-f257-4c67-b780-c356aadd6980	Product name	3	20150902
5a9b579b-8431-5b3a-2ba4-86556704f873	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	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	SPL version
72657-108-11	SheWise	1 in 1 CARTON	TABLET	1	4
72657-108-11	SheWise	1 in 1 BLISTER PACK	TABLET	1	4
72657-108-12	SheWise	1 in 1 CARTON	TABLET	1	4
72657-108-12	SheWise	1 in 1 BLISTER PACK	TABLET	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72657-108-12	EA - Each	72657-108	a7b4f7a5-3f39-441d-960b-4a06143d23e3	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72657-108	SHEWISE (LEVONORGESTREL) TABLET [GLENMARK THERAPEUTICS INC., USA]	3	Current NDC, Legacy NDC, 4 package rows	20240104_7be13a7e-b4ff-4fe1-82a6-f9914596d72a.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 · 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 ndc (product): 72657-108
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483325	levonorgestrel 1.5 MG Oral Tablet	PSN	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	4
2730936	SheWise 1.5 MG Oral Tablet	PSN	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	4
2730936	levonorgestrel 1.5 MG Oral Tablet [Shewise]	SBD	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	4
483325	levonorgestrel 1.5 MG Oral Tablet	SCD	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	4
2730936	SheWise 1.5 MG Oral Tablet	SY	7be13a7e-b4ff-4fe1-82a6-f9914596d72a	4
483325	levonorgestrel 1.5 MG Oral Tablet	PSN	01c8c95c-6fbe-4068-915d-74418a6bb570	1
2049247	PostDay One-Step Emergency Contraceptive 1.5 MG Oral Tablet	PSN	01c8c95c-6fbe-4068-915d-74418a6bb570	1
2049247	levonorgestrel 1.5 MG Oral Tablet [PostDay One-Step]	SBD	01c8c95c-6fbe-4068-915d-74418a6bb570	1
483325	levonorgestrel 1.5 MG Oral Tablet	SCD	01c8c95c-6fbe-4068-915d-74418a6bb570	1
2049247	PostDay One-Step 1.5 MG Oral Tablet	SY	01c8c95c-6fbe-4068-915d-74418a6bb570	1
2049247	PostDay One-Step Emergency Contraceptive 1.5 MG Oral Tablet	SY	01c8c95c-6fbe-4068-915d-74418a6bb570	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72657-108-11	72657010811	1 BLISTER PACK in 1 CARTON (72657-108-11) > 1 TABLET in 1 BLISTER PACK	1 blister pack	2022-07-29	0000-00-00	No	No	Current
72657-108-12	72657010812	1 BLISTER PACK in 1 CARTON (72657-108-12) / 1 TABLET in 1 BLISTER PACK	1 blister pack	2022-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levonorgestrel Tablet	GLENMARK THERAPEUTICS INC., USA \| Glenmark Pharmaceuticals Limited	2026-07-15	HUMAN OTC DRUG LABEL	5
PostDay ® One-Step	Home Health Brands, LLC	2025-04-23	HUMAN OTC DRUG LABEL	1