FDA.reportPublic FDA data

Ondansetron

Product NDC
63187-256
11-digit product format
631870256
Labeler code
63187
Product ID
63187-256_3ccb1196-6b72-478b-ba07-b05849ae83e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894, 312087

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-256-04Ondansetron4 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING411
63187-256-05Ondansetron5 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING511
63187-256-06Ondansetron6 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING611
63187-256-10Ondansetron10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1011
63187-256-12Ondansetron12 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1211
63187-256-15Ondansetron15 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1511
63187-256-20Ondansetron20 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING2011
63187-256-30Ondansetron30 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-256ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]9Current NDC, Legacy NDC, 8 package rows20240927_81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411
312087ondansetron 8 MG Disintegrating Oral TabletPSN81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411
104894ondansetron 4 MG Disintegrating Oral TabletSCD81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411
312087ondansetron 8 MG Disintegrating Oral TabletSCD81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-256-04631870256044 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-04) 2024-09-19NoNoCurrent
63187-256-05631870256055 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-05) 2022-12-280000-00-00NoNoCurrent
63187-256-06631870256066 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-06) 2024-01-24NoNoCurrent
63187-256-106318702561010 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-10) 2022-12-280000-00-00NoNoCurrent
63187-256-126318702561212 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-12) 2024-03-26NoNoCurrent
63187-256-156318702561515 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-15) 2022-12-280000-00-00NoNoCurrent
63187-256-206318702562020 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-20) 2017-06-010000-00-00NoNoCurrent
63187-256-306318702563030 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-30) 2017-06-010000-00-00NoNoCurrent