FDA.reportPublic FDA data

Ondansetron

Product NDC
83008-026
11-digit product format
830080026
Labeler code
83008
Product ID
83008-026_96d3ce0e-ecf6-4f8c-a148-89ce08e74c36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078152
Marketing category
ANDA
Marketing start
2023-05-12
Marketing end
2026-06-30
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron

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
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
83008-026-10Ondansetron10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING103
83008-026-65Ondansetron30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83008-026-10EA - Each83008-026b51a7e0f-0398-407a-bebb-20e1754c270b12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83008-026ONDANSETRON TABLET, ORALLY DISINTEGRATING [QUALITY CARE PRODUCTS, LLC]3Current NDC, 2 package rows20241222_318c2f90-d4ad-49e7-b885-cfb132b4cd17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN318c2f90-d4ad-49e7-b885-cfb132b4cd173
104894ondansetron 4 MG Disintegrating Oral TabletSCD318c2f90-d4ad-49e7-b885-cfb132b4cd173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83008-026-108300800261010 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (83008-026-10) 2023-05-122026-06-30NoNoHistorical
83008-026-658300800266530 in 1 BLISTER PACKHistorical