Ondansetron

Product NDC
63323-373
11-digit product format
633230373
Labeler code
63323
Product ID
63323-373_83824969-e116-40d6-8940-ff134a4f16c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA076972
Marketing category
ANDA
Marketing start
2009-11-18
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

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
A076972-001ONDANSETRON 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
A076972-001AP

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-263f01610625f2…
2019-09-15 20:21 UTC2019-09A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076972-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2006-12-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076972-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076972-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076972-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076972-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076972-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076972-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076972-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076972-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076972-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076972-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076972-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076972-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076972-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076972-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076972-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076972-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076972-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076972-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076972-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076972-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076972-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A076972-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076972-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076972-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076972-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A076972-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076972-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076972-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076972-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076972-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076972-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076972-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076972-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076972-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076972-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076972-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076972-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076972-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076972-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076972-001AP1cb3db0bc1861…

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 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283504Internal RxNorm lookup
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
e0050959-c14c-41b6-9a92-fadc5f6feff3Available 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-373-00Ondansetron2 mL in 1 VIALINJECTION213
63323-373-02Ondansetron25 in 1 TRAYINJECTION2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-373-02ML - Milliliter63323-373b92cbced-9a6e-440a-b1b4-85d324a57f4712012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-373ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]13Current NDC, Legacy NDC, 2 package rows20231109_e0050959-c14c-41b6-9a92-fadc5f6feff3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLC6a231919-6837-4b09-b66d-3706432b97022023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076972
application number: ANDA076972
OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCe0050959-c14c-41b6-9a92-fadc5f6feff32023-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076972
application number: ANDA076972
ndc (product): 63323-373
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst993cd1d7-70a1-a431-e053-2a95a90a57712022-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076972
application number: ANDA076972

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSNe0050959-c14c-41b6-9a92-fadc5f6feff313
1740467ondansetron 4 MG in 2 ML InjectionPSNe0050959-c14c-41b6-9a92-fadc5f6feff313
17404672 ML ondansetron 2 MG/ML InjectionSCDe0050959-c14c-41b6-9a92-fadc5f6feff313
283504ondansetron 2 MG/ML Injectable SolutionSCDe0050959-c14c-41b6-9a92-fadc5f6feff313
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSYe0050959-c14c-41b6-9a92-fadc5f6feff313
1740467ondansetron 4 MG per 2 ML InjectionSYe0050959-c14c-41b6-9a92-fadc5f6feff313
1740467ondansetron 4 MG in 2 ML InjectionPSN993cd1d7-70a1-a431-e053-2a95a90a57713
17404672 ML ondansetron 2 MG/ML InjectionSCD993cd1d7-70a1-a431-e053-2a95a90a57713
1740467ondansetron 4 MG per 2 ML InjectionSY993cd1d7-70a1-a431-e053-2a95a90a57713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-373-00633230373002 mL in 1 VIAL2 mlHistorical
63323-373-026332303730225 VIAL in 1 TRAY (63323-373-02) / 2 mL in 1 VIAL (63323-373-00) 25 vial2009-11-180000-00-00NoNoCurrent