Plan B One-Step

Product NDC: 51285-146
11-digit product format: 512850146
Labeler code: 51285
Product ID: 51285-146_4bf9c544-285a-414d-b156-0941595f65d4
Type: HUMAN OTC DRUG
Nonproprietary name: Levonorgestrel
Dosage form: TABLET
Route: ORAL
Labeler: Teva Women's Health, Inc.
Application: NDA021998
Marketing category: NDA
Marketing start: 2013-12-18
Marketing end: 2021-03-31
Substance: LEVONORGESTREL
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51285-146		D	Discontinued by firm		2026-08-10
excluded package	package	51285-146	51285-146-19	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 · 24 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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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	51285-146-19	`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
N021998-001	PLAN B ONE-STEP	LEVONORGESTREL	1.5MG	TABLET / ORAL		RLD, RS	2009-07-10

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021998-001	PLAN B ONE-STEP	1.5MG	TABLET / ORAL	RLD, RS	2009-07-10	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51285-146-19	EA - Each	51285-146	24d7c7e6-d739-42b5-8007-29260b04aa64	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]	2

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Plan B One-Step	LEVONORGESTREL	A-S Medication Solutions	fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064	2023-10-24	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998
Next Choice One Dose	LEVONORGESTREL	Foundation Consumer Healthcare LLC	504735bd-6af9-4588-bf85-d09dbf2a7e41	2023-02-02	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998
Take Action	LEVONORGESTREL	Foundation Consumer Healthcare LLC	78eee7c9-5ca5-45af-898f-92a2f3b2598e	2023-01-31	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998
Aftera	LEVONORGESTREL	Foundation Consumer Healthcare LLC	53ad8dff-9134-475c-90b3-8087753e17c4	2023-01-31	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998
Plan B One-Step	LEVONORGESTREL	Foundation Consumer Healthcare LLC	6ce6b40e-14ac-47bd-a648-ddf9e452e559	2023-01-31	Warnings	Exact identifier application applno (NDA): 021998 application number: NDA021998

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	5b7f49c5-8271-476d-9cbb-9f13e8a51f1d	7
858079	Plan B One-Step 1.5 MG Oral Tablet	PSN	5b7f49c5-8271-476d-9cbb-9f13e8a51f1d	7
858079	levonorgestrel 1.5 MG Oral Tablet [Plan B One-Step]	SBD	5b7f49c5-8271-476d-9cbb-9f13e8a51f1d	7
483325	levonorgestrel 1.5 MG Oral Tablet	SCD	5b7f49c5-8271-476d-9cbb-9f13e8a51f1d	7
858079	Plan B One-Step 1.5 MG Oral Tablet	SY	5b7f49c5-8271-476d-9cbb-9f13e8a51f1d	7
483325	levonorgestrel 1.5 MG Oral Tablet	PSN	716af323-e746-456a-9f74-6f46cab4b4bf	4
858079	Plan B One-Step 1.5 MG Oral Tablet	PSN	716af323-e746-456a-9f74-6f46cab4b4bf	4
858079	levonorgestrel 1.5 MG Oral Tablet [Plan B One-Step]	SBD	716af323-e746-456a-9f74-6f46cab4b4bf	4
483325	levonorgestrel 1.5 MG Oral Tablet	SCD	716af323-e746-456a-9f74-6f46cab4b4bf	4
858079	Plan B One-Step 1.5 MG Oral Tablet	SY	716af323-e746-456a-9f74-6f46cab4b4bf	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51285-146-19	51285014619	1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-146-19) > 1 TABLET in 1 BLISTER PACK	1 blister pack	2013-12-18	2021-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Plan B One-Step ®	A-S Medication Solutions	2021-02-22	HUMAN OTC DRUG LABEL	7
Plan B One-Step ®	Teva Women's Health, Inc.	2018-12-17	HUMAN OTC DRUG LABEL	5
Plan B One-Step ®	Central Texas Community Health Centers \| Travis County Healthcare District	2018-04-26	HUMAN OTC DRUG LABEL	4