Morning After

Product NDC
69953-514
11-digit product format
699530514
Labeler code
69953
Product ID
69953-514_9a65423c-5cdc-6aea-e053-2a95a90a919d
Type
HUMAN OTC DRUG
Nonproprietary name
Levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Rapha Pharmaceuticals, Inc.
Application
ANDA202334
Marketing category
ANDA
Marketing start
2016-08-21
Marketing end
0000-00-00
Substance
LEVONORGESTREL
Active strength
2 mg/1.5mg
NDC exclude flag
No
Listing certified through
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69953-514IInactivated by FDA2026-08-10
excluded packagepackage69953-51469953-514-01IInactivated by FDA2026-08-10

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69953-514-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69953-514-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69953-514-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69953-514-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69953-514-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69953-514-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69953-514-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69953-514-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69953-514-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69953-514-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69953-514-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69953-514-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69953-514-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69953-514-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69953-514-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69953-514-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69953-514-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69953-514-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69953-514-018dfbde2a14a4…c9ff85d89658…

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
A202334-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2014-08-20

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 UTC2026-02A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202334-001LEVONORGESTREL1.5MGTABLET / ORAL2014-08-20cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69953-514-012021-01-29C16284748780-1ba0f9c33-2162-a910-e053-dadaa90a0b851aeedfda-1686-7500-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69953-514-01Morning After1 in 1 CARTONTABLET14
69953-514-01Morning After1 mg in 1 BLISTER PACKTABLET14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69953-514MORNING AFTER (LEVONORGESTREL) TABLET [RAPHA PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20191224_1aeedfda-1686-7500-e054-00144ff88e88.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPTION 2LEVONORGESTRELL. Perrigo Company7d7b9e61-9f3d-477d-b74d-b0cc725f9bba2026-06-25WarningsExact identifier
application applno (ANDA): 202334
application number: ANDA202334
Option 2LEVONORGESTRELL. Perrigo Company9b9e9352-3e4d-4ec3-96aa-8fd58d82fe962020-07-30WarningsExact identifier
application applno (ANDA): 202334
application number: ANDA202334

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN1aeedfda-1686-7500-e054-00144ff88e884
1657617Morning After 1.5 MG Oral TabletPSN1aeedfda-1686-7500-e054-00144ff88e884
1657617levonorgestrel 1.5 MG Oral Tablet [Morning After]SBD1aeedfda-1686-7500-e054-00144ff88e884
483325levonorgestrel 1.5 MG Oral TabletSCD1aeedfda-1686-7500-e054-00144ff88e884
1657617Morning After 1.5 MG Oral TabletSY1aeedfda-1686-7500-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69953-514-01699530514011 in 1 CARTONHistorical