Ondansetron

Product NDC
0409-2271
11-digit product format
004092271
Labeler code
0409
Product ID
0409-2271_e0862c02-781f-4b10-ae50-9c9c4ca26f6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA077548
Marketing category
ANDA
Marketing start
2025-12-01
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
0409-2271-02Ondansetron2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21
0409-2271-25Ondansetron25 in 1 TRAYINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2271-02ML - Milliliter0409-2271811639be-d865-43df-8a52-97adeaed63a412026-01-08
0409-2271-25ML - Milliliter0409-22718bd78f87-4d81-4353-ab42-18a073a885db12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSNe0862c02-781f-4b10-ae50-9c9c4ca26f6d1
17404672 ML ondansetron 2 MG/ML InjectionSCDe0862c02-781f-4b10-ae50-9c9c4ca26f6d1
1740467ondansetron 4 MG per 2 ML InjectionSYe0862c02-781f-4b10-ae50-9c9c4ca26f6d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-2271-02004092271022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0409-2271-250040922712525 VIAL, SINGLE-DOSE in 1 TRAY (0409-2271-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-2271-02) 2025-12-01NoNoCurrent