FDA.reportPublic FDA data

Ondansetron

Product NDC
0409-0009
11-digit product format
004090009
Labeler code
0409
Product ID
0409-0009_2c782e5a-aea8-423f-864d-40dcdb7f5864
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA077548
Marketing category
ANDA
Marketing start
2024-12-16
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077548-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077548-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077548-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077548-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONCardinal Health 107, LLC1b9c2d9f-62a8-4d26-a041-a598bc59e3002026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077548
application number: ANDA077548
OndansetronONDANSETRONHospira, Inc.d62cd60b-f87e-4825-bead-1d18bbc4e4802026-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077548
application number: ANDA077548
ndc (product): 0409-0009
OndansetronONDANSETRONHospira, Inc.6a11f61b-2318-4382-2b91-4366e4bb53fa2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077548
application number: ANDA077548
OndansetronONDANSETRONHospira, Inc.e0862c02-781f-4b10-ae50-9c9c4ca26f6d2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077548
application number: ANDA077548
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst99ac0a5e-dd2a-4352-e053-2a95a90a68fd2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077548
application number: ANDA077548
OndansetronONDANSETRONMedical Purchasing Solutions, LLC89698ef8-62d3-77e4-e053-2995a90ab9db2023-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077548
application number: ANDA077548

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NMH84OZK2BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1740467Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d62cd60b-f87e-4825-bead-1d18bbc4e480Available on FDA.report

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
0409-0009-02Ondansetron2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION24
0409-0009-25Ondansetron25 in 1 TRAYINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0009-02ML - Milliliter0409-0009982635e2-7b68-47b2-b305-6c820e9d3fd912025-01-14
0409-0009-25ML - Milliliter0409-000951dc31b2-eebb-4552-a828-a20daadf204d12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0009ONDANSETRON INJECTION, SOLUTION [HOSPIRA, INC.]2Current NDC, 2 package rows20250309_d62cd60b-f87e-4825-bead-1d18bbc4e480.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740467ondansetron 4 MG in 2 ML InjectionPSNd62cd60b-f87e-4825-bead-1d18bbc4e4804
17404672 ML ondansetron 2 MG/ML InjectionSCDd62cd60b-f87e-4825-bead-1d18bbc4e4804
1740467ondansetron 4 MG per 2 ML InjectionSYd62cd60b-f87e-4825-bead-1d18bbc4e4804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-0009-02004090009022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0409-0009-250040900092525 VIAL, SINGLE-DOSE in 1 TRAY (0409-0009-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0009-02) 2024-12-16NoNoCurrent