Ondansetron

Product NDC
70860-777
11-digit product format
708600777
Labeler code
70860
Product ID
70860-777_e24e8318-7890-4329-8cdb-2133cf4c29bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA090648
Marketing category
ANDA
Marketing start
2017-01-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70860-777DDiscontinued by firm2026-08-11
excluded packagepackage70860-77770860-777-20DDiscontinued by firm2026-08-11
excluded packagepackage70860-77770860-777-21DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70860-777-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70860-777-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70860-777-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70860-777-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70860-777-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70860-777-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70860-777-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70860-777-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70860-777-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70860-777-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70860-777-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70860-777-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70860-777-20557ba5c1ecfa…9c80585c8c6e…

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
A090648-001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090648-001AP

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 UTC2026-02A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090648-001ONDANSETRON HYDROCHLORIDEEQ 2MG BASE/MLINJECTABLE / INJECTIONAPRS2012-06-15cb3db0bc1861…

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 UTC2026-02A090648-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090648-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090648-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090648-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090648-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090648-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090648-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090648-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090648-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090648-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090648-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090648-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090648-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090648-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090648-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090648-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090648-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090648-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090648-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090648-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090648-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A090648-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090648-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090648-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090648-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090648-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090648-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090648-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090648-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090648-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090648-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090648-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090648-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090648-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090648-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090648-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090648-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090648-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090648-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090648-001AP1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-777-20ML - Milliliter70860-777fd53adbd-1eb4-4ed5-aeb7-a353e274491a12017-03-06
70860-777-21ML - Milliliter70860-777ab0de225-eb40-4ade-8b82-957cba4c911212021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-777ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]11Legacy NDC20240306_04e315ea-f820-4ae2-b237-ea5b8722fa9f.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONJVET PHARMACEUTICALS LLC95ca0d81-a0a8-441d-820e-cb6624018a152026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090648
application number: ANDA090648
ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b746d4db-43e6-4219-9e6b-f53e595813052026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090648
application number: ANDA090648
OndansetronONDANSETRONFosun Pharma USA Inc.e3f22b7e-b6ad-4799-93c7-d30540cada852025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090648
application number: ANDA090648
OndansetronONDANSETRONGland Pharma Limited35716914-ac73-43c0-9aa0-09c99211d9412025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090648
application number: ANDA090648
ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d082024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090648
application number: ANDA090648

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70860-777-20708600777201 VIAL, MULTI-DOSE in 1 CARTON (70860-777-20) > 20 mL in 1 VIAL, MULTI-DOSE2018-03-010000-00-00NoNoCurrent
70860-777-217086007772110 VIAL, MULTI-DOSE in 1 CARTON (70860-777-21) > 20 mL in 1 VIAL, MULTI-DOSE2021-02-150000-00-00NoNoCurrent