FDA.reportPublic FDA data

Ondansetron

Product NDC
72572-520
11-digit product format
725720520
Labeler code
72572
Product ID
72572-520_0c34b5a6-e21b-41e7-8e7b-61a9706b67e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA077541
Marketing category
ANDA
Marketing start
2019-11-18
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
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
72572-520-01Ondansetron2 mL in 1 VIALINJECTION23
72572-520-25Ondansetron25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-520-01ML - Milliliter72572-5203ca7493e-8827-46b3-83c5-7fcf2aabcad812019-12-10
72572-520-25ML - Milliliter72572-520564337fc-db4d-4bc3-ae10-9b510ed38e9312019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-520ONDANSETRON INJECTION [CIVICA, INC.]3Current NDC, Legacy NDC, 2 package rows20220525_70437694-0341-4f3b-824c-06843403443f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSN70437694-0341-4f3b-824c-06843403443f3
17404672 ML ondansetron 2 MG/ML InjectionSCD70437694-0341-4f3b-824c-06843403443f3
1740467ondansetron 4 MG per 2 ML InjectionSY70437694-0341-4f3b-824c-06843403443f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-520-01725720520012 mL in 1 VIAL2 mlHistorical
72572-520-257257205202525 VIAL in 1 CARTON (72572-520-25) / 2 mL in 1 VIAL (72572-520-01) 25 vial2019-11-180000-00-00NoNoCurrent