Julie

Product NDC: 82791-332
11-digit product format: 827910332
Labeler code: 82791
Product ID: 82791-332_ef666371-6d7d-3f37-e053-2a95a90ace07
Type: HUMAN OTC DRUG
Nonproprietary name: Levonorgestrel
Dosage form: TABLET
Route: ORAL
Labeler: Julie Products, Inc
Application: ANDA202380
Marketing category: ANDA
Marketing start: 2022-12-27
Marketing end: 0000-00-00
Substance: LEVONORGESTREL
Active strength: 2 mg/1
Pharmacologic classes: Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	82791-332		I	Inactivated by FDA		2026-08-11
excluded package	package	82791-332	82791-332-01	I	Inactivated by FDA		2026-08-11

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82791-332-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82791-332-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82791-332-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82791-332-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82791-332-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82791-332-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82791-332-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82791-332-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82791-332-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A202380-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2015-05-29

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	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202380-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2015-05-29	`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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82791-332-01	2025-01-30	C162847	48780-1	2cef2736-a019-d83d-e063-dadaa90ab31f	Julie™ (Levonorgestrel Tablet, 1.5 mg) Emergency Contraceptive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82791-332-01	Julie	1 in 1 CARTON	TABLET	1		2
82791-332-01	Julie	1 in 1 BLISTER PACK	TABLET	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82791-332	JULIE (LEVONORGESTREL) TABLET [JULIE PRODUCTS, INC]	2	Legacy NDC, 2 package rows	20230525_42c1be8a-74dd-407a-b5b0-04e3a3ae61e2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morning After Pill	LEVONORGESTREL	Cadence Health Inc	fc5d29bb-4a4b-e61e-e053-6394a90a8a62	2025-02-14	Warnings	Exact identifier application applno (ANDA): 202380 application number: ANDA202380
Optionelle	LEVONORGESTREL TABLET, 1.5 MG	Strides Pharma Inc	1c7e849c-6392-48a6-9214-907325a012e2	2022-09-16	Warnings	Exact identifier application applno (ANDA): 202380 application number: ANDA202380
Levonorgestrel Tablet, 1.5 mg	LEVONORGESTREL TABLET, 1.5 MG	Strides Pharma Inc	98f6367e-14d2-4c7a-9418-d996f0040d22	2022-09-13	Warnings	Exact identifier application applno (ANDA): 202380 application number: ANDA202380

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
2606549	Julie 1.5 MG Oral Tablet	PSN	42c1be8a-74dd-407a-b5b0-04e3a3ae61e2	2
483325	levonorgestrel 1.5 MG Oral Tablet	PSN	42c1be8a-74dd-407a-b5b0-04e3a3ae61e2	2
2606549	levonorgestrel 1.5 MG Oral Tablet [Julie]	SBD	42c1be8a-74dd-407a-b5b0-04e3a3ae61e2	2
483325	levonorgestrel 1.5 MG Oral Tablet	SCD	42c1be8a-74dd-407a-b5b0-04e3a3ae61e2	2
2606549	Julie 1.5 MG Oral Tablet	SY	42c1be8a-74dd-407a-b5b0-04e3a3ae61e2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82791-332-01	82791033201	1 BLISTER PACK in 1 CARTON (82791-332-01) > 1 TABLET in 1 BLISTER PACK	1 blister pack	2022-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Julie™ (Levonorgestrel Tablet, 1.5 mg) Emergency Contraceptive	Julie Products, Inc \| Naari Pte. Limited \| Haupt Pharma Muenster GmbH	2023-05-24	HUMAN OTC DRUG LABEL	2