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Ondansetron

These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

Approved
Approval ID

889e1603-06d7-4a5e-86ed-9d758195175f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2023

Manufacturers
FDA

RPK Pharmaceuticals, Inc.

DUNS: 147096275

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ondansetron

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53002-0582
Application NumberANDA090469
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2022
FDA Product Classification

INGREDIENTS (8)

ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 12/24/2021

RECENT MAJOR CHANGES

Warnings and Precautions, Myocardial Ischemia (5.4) 10/2021

DRUG ABUSE AND DEPENDENCE SECTION

LOINC: 42227-9Updated: 12/24/2021

9 DRUG ABUSE AND DEPENDENCE

Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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Ondansetron - FDA Drug Approval Details