Ondansetron

Product NDC
0781-1681
11-digit product format
007811681
Labeler code
0781
Product ID
0781-1681_aeb4f81b-0b25-4aac-9d7b-f135d2d18fee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA077517
Marketing category
ANDA
Marketing start
2007-06-25
Marketing end
2019-11-30
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0781-1681DDiscontinued by firm2026-08-03
excluded packagepackage0781-16810781-1681-31DDiscontinued by firm2026-08-03
excluded packagepackage0781-16810781-1681-33DDiscontinued by firm2026-08-03

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 · 36 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 packagepackage0781-1681-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-1681-33d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1681-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1681-33f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1681-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1681-332ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1681-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1681-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1681-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1681-33cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1681-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1681-33cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1681-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1681-33302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1681-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1681-33ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1681-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1681-330efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1681-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1681-33ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1681-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1681-33367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1681-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1681-33557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077517-001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25
A077517-002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25
A077517-003ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-25

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077517-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077517-003ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2007-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077517-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-258072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077517-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077517-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077517-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077517-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077517-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077517-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077517-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077517-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077517-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077517-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077517-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077517-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077517-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077517-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077517-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077517-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077517-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077517-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077517-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077517-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077517-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077517-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077517-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077517-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077517-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077517-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077517-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077517-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077517-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077517-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077517-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077517-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077517-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077517-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077517-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077517-003AB1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077517-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077517-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077517-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077517-002AB19b2671bbb829…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1681-31EA - Each0781-1681e0f0ec9c-1186-4ad0-ab7d-e1f9dd76869312012-07-24
0781-1681-33EA - Each0781-16816f9d9e40-28e8-4b78-baef-b48b821931cb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, FILM COATED [SANDOZ INC]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED [SANDOZ INC]14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNe3331557-ed5a-466e-b174-1debb1938dc31
312086ondansetron 8 MG Oral TabletSCDe3331557-ed5a-466e-b174-1debb1938dc31
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYe3331557-ed5a-466e-b174-1debb1938dc31