FDA.reportPublic FDA data

ONDANSETRON

Product NDC
63187-670
11-digit product format
631870670
Labeler code
63187
Product ID
63187-670_f302f985-2fc7-4ba8-bcc5-4ff5e4e127dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
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

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
63187-670-10ONDANSETRON10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
63187-670-15ONDANSETRON15 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING153
63187-670-20ONDANSETRON20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING203
63187-670-30ONDANSETRON30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-670-30EA - Each63187-6709792aa63-c73c-4eb3-9621-500963cdd48212016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-670ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20210112_9913ed0c-aaad-45e1-b522-98ad170c2e8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN9913ed0c-aaad-45e1-b522-98ad170c2e8a3
104894ondansetron 4 MG Disintegrating Oral TabletSCD9913ed0c-aaad-45e1-b522-98ad170c2e8a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-670-106318706701010 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-10) 2018-12-010000-00-00NoNoCurrent
63187-670-156318706701515 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-15) 2018-12-010000-00-00NoNoCurrent
63187-670-206318706702020 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-20) 2018-12-010000-00-00NoNoCurrent
63187-670-306318706703030 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-30) 2018-12-010000-00-00NoNoCurrent