Morning After Pill

Product NDC
73436-2859
11-digit product format
734362859
Labeler code
73436
Product ID
73436-2859_2e251776-063e-0e05-e063-6294a90a8e98
Type
HUMAN OTC DRUG
Nonproprietary name
levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Cadence Health Inc
Application
ANDA202380
Marketing category
ANDA
Marketing start
2023-10-01
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct73436-2859UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73436-285973436-2859-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202380-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2015-05-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Morning After Pill
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483325Internal RxNorm lookup
1657617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc5d29bb-4a4b-e61e-e053-6394a90a8a62Available 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
73436-2859-1Morning After Pill1 in 1 BLISTER PACKTABLET14
73436-2859-1Morning After Pill1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73436-2859MORNING AFTER PILL (LEVONORGESTREL) TABLET [CADENCE HEALTH INC]4Current NDC, 2 package rows20250217_fc5d29bb-4a4b-e61e-e053-6394a90a8a62.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morning After PillLEVONORGESTRELCadence Health Incfc5d29bb-4a4b-e61e-e053-6394a90a8a622025-02-14WarningsExact identifier
application applno (ANDA): 202380
application number: ANDA202380
ndc (product): 73436-2859
OptionelleLEVONORGESTREL TABLET, 1.5 MGStrides Pharma Inc1c7e849c-6392-48a6-9214-907325a012e22022-09-16WarningsExact identifier
application applno (ANDA): 202380
application number: ANDA202380
Levonorgestrel Tablet, 1.5 mgLEVONORGESTREL TABLET, 1.5 MGStrides Pharma Inc98f6367e-14d2-4c7a-9418-d996f0040d222022-09-13WarningsExact identifier
application applno (ANDA): 202380
application number: ANDA202380

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483325levonorgestrel 1.5 MG Oral TabletPSNfc5d29bb-4a4b-e61e-e053-6394a90a8a624
1657617Morning After 1.5 MG Oral TabletPSNfc5d29bb-4a4b-e61e-e053-6394a90a8a624
1657617levonorgestrel 1.5 MG Oral Tablet [Morning After]SBDfc5d29bb-4a4b-e61e-e053-6394a90a8a624
483325levonorgestrel 1.5 MG Oral TabletSCDfc5d29bb-4a4b-e61e-e053-6394a90a8a624
1657617Morning After 1.5 MG Oral TabletSYfc5d29bb-4a4b-e61e-e053-6394a90a8a624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73436-2859-1734362859011 BLISTER PACK in 1 CARTON (73436-2859-1) / 1 TABLET in 1 BLISTER PACK1 blister pack2023-10-01NoNoCurrent