FDA.reportPublic FDA data

ONDANSETRON

Product NDC
60505-6130
11-digit product format
605056130
Labeler code
60505
Product ID
60505-6130_96665be2-8af7-4ee7-89f4-bdceb16913a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA203711
Marketing category
ANDA
Marketing start
2016-05-26
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
2 mg/mL
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 HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui1740467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-6130-0ONDANSETRON2 mL in 1 VIAL, SINGLE-USEINJECTION212
60505-6130-5ONDANSETRON25 in 1 CARTONINJECTION2512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6130-0ML - Milliliter60505-6130e9174a08-b6b2-4437-af3f-e5bb09c5cbf412016-05-16
60505-6130-5ML - Milliliter60505-6130a5f9938f-96b9-417d-b2cc-f9f55cc2ad3512016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6130ONDANSETRON INJECTION [APOTEX CORP.]11Current NDC, Legacy NDC, 2 package rows20250216_2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSN2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a12
17404672 ML ondansetron 2 MG/ML InjectionSCD2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a12
1740467ondansetron 4 MG per 2 ML InjectionSY2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a12
1740467ondansetron 4 MG in 2 ML InjectionPSNb60074e5-8e77-4dc0-9244-4205e4adbaef11
17404672 ML ondansetron 2 MG/ML InjectionSCDb60074e5-8e77-4dc0-9244-4205e4adbaef11
1740467ondansetron 4 MG per 2 ML InjectionSYb60074e5-8e77-4dc0-9244-4205e4adbaef11
1740467ondansetron 4 MG in 2 ML InjectionPSN1a44601b-c31c-4779-a688-28cc4cc75e8b6
17404672 ML ondansetron 2 MG/ML InjectionSCD1a44601b-c31c-4779-a688-28cc4cc75e8b6
1740467ondansetron 4 MG per 2 ML InjectionSY1a44601b-c31c-4779-a688-28cc4cc75e8b6
1740467ondansetron 4 MG in 2 ML InjectionPSN677b5fc5-9471-638b-e053-2991aa0a7f973
17404672 ML ondansetron 2 MG/ML InjectionSCD677b5fc5-9471-638b-e053-2991aa0a7f973
1740467ondansetron 4 MG per 2 ML InjectionSY677b5fc5-9471-638b-e053-2991aa0a7f973
1740467ondansetron 4 MG in 2 ML InjectionPSN3d5d25eb-8711-ef8c-e063-6394a90a5e031
17404672 ML ondansetron 2 MG/ML InjectionSCD3d5d25eb-8711-ef8c-e063-6394a90a5e031
1740467ondansetron 4 MG per 2 ML InjectionSY3d5d25eb-8711-ef8c-e063-6394a90a5e031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-6130-0605056130002 mL in 1 VIAL, SINGLE-USE2 mlHistorical
60505-6130-56050561300525 VIAL, SINGLE-USE in 1 CARTON (60505-6130-5) / 2 mL in 1 VIAL, SINGLE-USE (60505-6130-0) 2016-05-260000-00-00NoNoCurrent