FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
54348-821
11-digit product format
543480821
Labeler code
54348
Product ID
54348-821_eaa58b56-e847-aab7-e053-2995a90a49c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharmpak, Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2019-08-08
Substance
ONDANSETRON HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312086

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
54348-821-00Ondansetron Hydrochloride1 in 1 BOXTABLET, FILM COATED12
54348-821-00Ondansetron Hydrochloride1 in 1 BOTTLETABLET, FILM COATED12
54348-821-02Ondansetron Hydrochloride2 in 1 BOTTLETABLET, FILM COATED22
54348-821-02Ondansetron Hydrochloride1 in 1 BOXTABLET, FILM COATED12
54348-821-04Ondansetron Hydrochloride4 in 1 BOTTLETABLET, FILM COATED42
54348-821-04Ondansetron Hydrochloride1 in 1 BOXTABLET, FILM COATED12
54348-821-05Ondansetron Hydrochloride5 in 1 BOTTLETABLET, FILM COATED52
54348-821-05Ondansetron Hydrochloride1 in 1 BOXTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-821ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHARMPAK, INC.]2Current NDC, Legacy NDC, 8 package rows20221011_e41b9469-e844-47d9-933a-4c9f4453ecc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNe41b9469-e844-47d9-933a-4c9f4453ecc72
312086ondansetron 8 MG Oral TabletSCDe41b9469-e844-47d9-933a-4c9f4453ecc72
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYe41b9469-e844-47d9-933a-4c9f4453ecc72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-821-00543480821001 BOTTLE in 1 BOX (54348-821-00) / 1 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-821-02543480821021 BOTTLE in 1 BOX (54348-821-02) / 2 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-821-04543480821041 BOTTLE in 1 BOX (54348-821-04) / 4 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-821-05543480821051 BOTTLE in 1 BOX (54348-821-05) / 5 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent