FDA.reportPublic FDA data

Levonorgestrel

Product NDC
70000-0675
11-digit product format
700000675
Labeler code
70000
Product ID
70000-0675_192e44e9-722c-43bd-8a70-1ff05d7d99d8
Type
HUMAN OTC DRUG
Nonproprietary name
Levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
LEADER/ CARDINAL HEALTH 110, INC.
Application
ANDA206867
Marketing category
ANDA
Marketing start
2024-07-15
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-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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206867-001ATHENTIA NEXT1.5MGTABLET / ORAL2015-12-08cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVONORGESTREL1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5W7SIA7YZWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483325Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7d3a74e-37c4-4c49-861c-64ef363d5a53Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0675-1Levonorgestrel1 in 1 CARTONTABLET14
70000-0675-1Levonorgestrel1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0675LEVONORGESTREL TABLET [LEADER/ CARDINAL HEALTH 110, INC.]4Current NDC, 2 package rows20250408_c7d3a74e-37c4-4c49-861c-64ef363d5a53.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 · 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
ndc (product): 70000-0675
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483325levonorgestrel 1.5 MG Oral TabletPSNc7d3a74e-37c4-4c49-861c-64ef363d5a534
483325levonorgestrel 1.5 MG Oral TabletSCDc7d3a74e-37c4-4c49-861c-64ef363d5a534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0675-1700000675011 BLISTER PACK in 1 CARTON (70000-0675-1) / 1 TABLET in 1 BLISTER PACK1 blister pack2024-07-15NoNoCurrent