FDA.reportPublic FDA data

Julie Morning After Pill

Product NDC
82791-004
11-digit product format
827910004
Labeler code
82791
Product ID
82791-004_094d5260-3735-4122-a2ea-5b63c2e79bcb
Type
HUMAN OTC DRUG
Nonproprietary name
Levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Julie Products Inc.
Application
ANDA206867
Marketing category
ANDA
Marketing start
2026-09-17
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206867-001ATHENTIA NEXTLEVONORGESTREL1.5MGTABLET / ORAL2015-12-08

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Julie Morning After Pill
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVONORGESTREL1.5 mg/1

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevonorgestrelLEVONORGESTRELRugby Laboratories076126e4-9d76-45cd-a86b-5b35c56b620a2026-05-13WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bb96f0-d5f1-1ec3-e063-6294a90a74b12025-11-26WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bbad6f-0c54-e4ed-e063-6394a90af3ad2025-11-14WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
EContra One-StepLEVONORGESTRELAfaxys Pharma, LLC94b23c49-dfba-4a70-ada5-e5c212e703c52025-04-08WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
JulieLEVONORGESTRELJulie Products Inc.8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae82025-04-07WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
ITHAPPENZ MORNING AFTERLEVONORGESTRELAurohealth LLC5ee40793-0121-4b8f-b20d-3178bbe262e22025-04-07WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
JulieLEVONORGESTRELJulie Products Inc.8d20510f-a4e8-4d4b-a96a-f0da917858332025-04-07WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
Econ Morning AfterLEVONORGESTRELAurohealth LLC177daa65-2e7d-4ff4-887e-b927d6ed88252025-04-04WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
LevonorgestrelLEVONORGESTRELLEADER/ CARDINAL HEALTH 110, INC.c7d3a74e-37c4-4c49-861c-64ef363d5a532025-04-04WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
Fem Choice morning afterLEVONORGESTRELAurohealth LLC14051537-9d6c-4f73-a6e9-5eed554bbf652025-04-04WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
AMAZON BASIC CARE LEVONORGESTRELLEVONORGESTRELAmazon.com Services LLC10ecae6f-386f-e199-e063-6294a90a680b2025-04-04WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
Athentia NextLEVONORGESTRELAurohealth LLC34e5aa53-3943-4e2f-93aa-b5a4d779a7032025-04-04WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
After BangerLEVONORGESTRELAurohealth LLC791a2461-971c-4191-8905-5a449c600a492025-04-04WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867
Morning AfterLEVONORGESTRELRapha Pharmaceuticals, Inc.677aa953-3c30-4ce5-e053-2991aa0ab2b22018-03-15WarningsExact identifier
application applno (ANDA): 206867
application number: ANDA206867

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82791-004-01827910004011 BLISTER PACK in 1 CARTON (82791-004-01) / 1 TABLET in 1 BLISTER PACK1 blister pack2026-09-17NoNoCurrent