ONDANSETRON HYDROCHLORIDE

Product NDC
36000-012
11-digit product format
360000012
Labeler code
36000
Product ID
36000-012_f917f6a4-bb84-46ed-ba13-68e4c01097e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA078287
Marketing category
ANDA
Marketing start
2013-03-13
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 42.

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
A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078287-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-223f01610625f2…
2019-09-15 20:21 UTC2019-09A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078287-001ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2013-02-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078287-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078287-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078287-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078287-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078287-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078287-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078287-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078287-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078287-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078287-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078287-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078287-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078287-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078287-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078287-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078287-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078287-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078287-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078287-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078287-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078287-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078287-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078287-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078287-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078287-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078287-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078287-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078287-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078287-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078287-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078287-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078287-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078287-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078287-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078287-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078287-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078287-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078287-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078287-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078287-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
ONDANSETRON HYDROCHLORIDE
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
729d865f-d84a-495e-9456-4bceebb6e03fAvailable 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
36000-012-25ONDANSETRON HYDROCHLORIDE25 in 1 CARTONSOLUTION2522
36000-012-25ONDANSETRON HYDROCHLORIDE2 mL in 1 VIAL, SINGLE-DOSESOLUTION222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-012-25ML - Milliliter36000-0129cf1567e-8d91-4603-a1a1-528085c7c53612013-09-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-012ONDANSETRON HYDROCHLORIDE SOLUTION [BAXTER HEALTHCARE CORPORATION]20Current NDC, Legacy NDC, 2 package rows20240921_729d865f-d84a-495e-9456-4bceebb6e03f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDECardinal Health 107, LLC30107d6f-5128-484f-b713-65244a98dc672026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078287
application number: ANDA078287
ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEBaxter Healthcare Corporation729d865f-d84a-495e-9456-4bceebb6e03f2025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078287
application number: ANDA078287
ndc (product): 36000-012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSN729d865f-d84a-495e-9456-4bceebb6e03f22
1740467ondansetron 4 MG in 2 ML InjectionPSN729d865f-d84a-495e-9456-4bceebb6e03f22
17404672 ML ondansetron 2 MG/ML InjectionSCD729d865f-d84a-495e-9456-4bceebb6e03f22
283504ondansetron 2 MG/ML Injectable SolutionSCD729d865f-d84a-495e-9456-4bceebb6e03f22
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSY729d865f-d84a-495e-9456-4bceebb6e03f22
1740467ondansetron 4 MG per 2 ML InjectionSY729d865f-d84a-495e-9456-4bceebb6e03f22
1740467ondansetron 4 MG in 2 ML InjectionPSN30107d6f-5128-484f-b713-65244a98dc676
17404672 ML ondansetron 2 MG/ML InjectionSCD30107d6f-5128-484f-b713-65244a98dc676
1740467ondansetron 4 MG per 2 ML InjectionSY30107d6f-5128-484f-b713-65244a98dc676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36000-012-253600000122525 VIAL, SINGLE-DOSE in 1 CARTON (36000-012-25) / 2 mL in 1 VIAL, SINGLE-DOSE2013-03-130000-00-00NoNoCurrent