Levonorgestrel

Product NDC: 51660-999
11-digit product format: 516600999
Labeler code: 51660
Product ID: 51660-999_39163ee2-78d4-3c05-e063-6294a90a1304
Type: HUMAN OTC DRUG
Nonproprietary name: Levonorgestrel
Dosage form: TABLET
Route: ORAL
Labeler: Ohm Laboratories Inc.
Application: ANDA202635
Marketing category: ANDA
Marketing start: 2017-11-01
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: 2026-12-31
Current FDA listing: Yes

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
A202635-001	OPCICON ONE-STEP	LEVONORGESTREL	1.5MG	TABLET / ORAL			2014-09-11

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	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202635-001	OPCICON ONE-STEP	1.5MG	TABLET / ORAL	2014-09-11	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levonorgestrel
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483325	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
f3f2a41a-a9af-4d63-81d8-33181d12af40	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
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
51660-999-01	Levonorgestrel	1 in 1 CARTON	TABLET	1	4
51660-999-01	Levonorgestrel	1 in 1 BLISTER PACK	TABLET	1	4
51660-999-11	Levonorgestrel	1 in 1 CARTON	TABLET	1	4
51660-999-11	Levonorgestrel	1 in 1 BLISTER PACK	TABLET	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51660-999	LEVONORGESTREL TABLET [OHM LABORATORIES INC.]	3	Current NDC, Legacy NDC, 4 package rows	20240802_f3f2a41a-a9af-4d63-81d8-33181d12af40.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER Emergency Contraceptive Levonorgestrel	LEVONORGESTREL	Cardinal Health 110, LLC. DBA Leader	d1e33615-0a98-4223-833d-843c758d9db7	2026-05-06	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635
Levonorgestrel	LEVONORGESTREL	Ohm Laboratories Inc.	f3f2a41a-a9af-4d63-81d8-33181d12af40	2025-07-04	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635 ndc (product): 51660-999
Levonorgestrel	LEVONORGESTREL	Thirty Madison Inc.	6933ae19-4c8f-49a2-96c5-9cdf37ee5824	2024-12-30	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635
Levonorgestrel	LEVONORGESTREL	Ohm Laboratories Inc.	5c509934-8c11-4d7f-8506-5971c37cfc22	2024-09-06	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635
Opcicon One-Step	LEVONORGESTREL	Sun Pharmaceutical Industries, Inc.	b67ca313-561e-471f-baf3-257b7e253c75	2023-01-13	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635
My Choice TM	LEVONORGESTREL	Proficient Rx LP	165f7270-d050-4e97-b30f-107b96940d84	2022-09-01	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635
My Choice TM	LEVONORGESTREL	SUN PHARMACEUTICAL INDUSTRIES, INC.	66753300-fb61-4f09-af74-ee498b0bd595	2022-04-21	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635
AfterPlan	LEVONORGESTREL	SUN PHARMACEUTICAL INDUSTRIES, INC.	c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a	2018-10-26	Warnings	Exact identifier application applno (ANDA): 202635 application number: ANDA202635

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	f3f2a41a-a9af-4d63-81d8-33181d12af40	4
483325	levonorgestrel 1.5 MG Oral Tablet	SCD	f3f2a41a-a9af-4d63-81d8-33181d12af40	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51660-999-01	51660099901	1 BLISTER PACK in 1 CARTON (51660-999-01) / 1 TABLET in 1 BLISTER PACK	1 blister pack	2025-08-13		No	No	Current
51660-999-11	51660099911	1 BLISTER PACK in 1 CARTON (51660-999-11) / 1 TABLET in 1 BLISTER PACK	1 blister pack	2017-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levonorgestrel	Ohm Laboratories Inc. \| Sun Pharmaceutical Industries Limited	2025-07-04	HUMAN OTC DRUG LABEL	4