FDA.reportPublic FDA data

Ondansetron

Product NDC
54348-819
11-digit product format
543480819
Labeler code
54348
Product ID
54348-819_eaa5779b-4250-01ba-e053-2a95a90ae500
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2019-07-10
Substance
ONDANSETRON HYDROCHLORIDE
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
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052

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
54348-819-00Ondansetron1 in 1 BOXTABLET, FILM COATED14
54348-819-00Ondansetron1 in 1 BOTTLETABLET, FILM COATED14
54348-819-02Ondansetron2 in 1 BOTTLETABLET, FILM COATED24
54348-819-02Ondansetron1 in 1 BOXTABLET, FILM COATED14
54348-819-04Ondansetron1 in 1 BOXTABLET, FILM COATED14
54348-819-04Ondansetron4 in 1 BOTTLETABLET, FILM COATED44
54348-819-06Ondansetron1 in 1 BOXTABLET, FILM COATED14
54348-819-06Ondansetron6 in 1 BOTTLETABLET, FILM COATED64
54348-819-08Ondansetron8 in 1 BOTTLETABLET, FILM COATED84
54348-819-08Ondansetron1 in 1 BOXTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-819ONDANSETRON TABLET, FILM COATED [PHARMPAK, INC.]4Current NDC, Legacy NDC, 10 package rows20221011_8e289184-6046-4b55-97d2-cb276d5782d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN8e289184-6046-4b55-97d2-cb276d5782d54
198052ondansetron 4 MG Oral TabletSCD8e289184-6046-4b55-97d2-cb276d5782d54
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY8e289184-6046-4b55-97d2-cb276d5782d54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-819-00543480819001 BOTTLE in 1 BOX (54348-819-00) / 1 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-819-02543480819021 BOTTLE in 1 BOX (54348-819-02) / 2 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-819-04543480819041 BOTTLE in 1 BOX (54348-819-04) / 4 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-819-06543480819061 BOTTLE in 1 BOX (54348-819-06) / 6 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-819-08543480819081 BOTTLE in 1 BOX (54348-819-08) / 8 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent