FDA.reportPublic FDA data

Ondansetron

Product NDC
70518-1551
11-digit product format
705181551
Labeler code
70518
Product ID
70518-1551_494c4438-abc4-8734-e063-6394a90a46a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2018-10-23
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1551-0Ondansetron6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING613
70518-1551-1Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1013
70518-1551-1Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING313
70518-1551-2Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1013
70518-1551-3Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING313
70518-1551-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1551ONDANSETRON TABLET, ORALLY DISINTEGRATING [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 6 package rows20250226_18063a64-a4c0-4bad-911b-00df5c7bb65d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN18063a64-a4c0-4bad-911b-00df5c7bb65d13
312087ondansetron 8 MG Disintegrating Oral TabletSCD18063a64-a4c0-4bad-911b-00df5c7bb65d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1551-0705181551006 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (70518-1551-0) 2018-10-230000-00-00NoNoCurrent
70518-1551-1705181551013 BLISTER PACK in 1 CARTON (70518-1551-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2019-05-010000-00-00NoNoCurrent
70518-1551-27051815510210 in 1 BLISTER PACKHistorical
70518-1551-3705181551033 in 1 CARTONHistorical