FDA.reportPublic FDA data

Ondansetron

Product NDC
43063-870
11-digit product format
430630870
Labeler code
43063
Product ID
43063-870_3edb7f33-6452-d407-e063-6394a90a3977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
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
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
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
43063-870-02Ondansetron2 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING225
43063-870-04Ondansetron4 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING425
43063-870-10Ondansetron10 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-870-02EA - Each43063-8701e972e00-7bf0-4f9b-967e-b88daef6e5a912019-05-02
43063-870-04EA - Each43063-8705ba66bf3-03e7-424e-9590-bb0c20b2b7e012018-09-05
43063-870-10EA - Each43063-8705035ba8c-e4b6-4f18-a516-5234a2836e5012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-870ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 3 package rows20240704_10afd68b-877f-4819-a314-39f2d56d5db9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN10afd68b-877f-4819-a314-39f2d56d5db925
312087ondansetron 8 MG Disintegrating Oral TabletSCD10afd68b-877f-4819-a314-39f2d56d5db925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-870-02430630870022 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-02) 2019-04-010000-00-00NoNoCurrent
43063-870-04430630870044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-04) 2018-07-170000-00-00NoNoCurrent
43063-870-104306308701010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-10) 2018-07-260000-00-00NoNoCurrent