Ondansetron

Product NDC
43353-881
11-digit product format
433530881
Labeler code
43353
Product ID
43353-881_fb0c5f7c-c8ff-416a-8a21-4e788d401c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077517
Marketing category
ANDA
Marketing start
2007-06-25
Marketing end
0000-00-00
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
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-881IInactivated by FDA2026-08-03
excluded packagepackage43353-88143353-881-88IInactivated by FDA2026-08-03

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 · 42 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 packagepackage43353-881-88d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-881-88f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-881-882ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-881-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-881-88cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-881-88cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-881-88302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-881-88ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-881-880efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-881-88ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-881-88367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-881-88557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43353-881-888af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43353-881-88834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43353-881-881332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43353-881-88fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43353-881-8886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43353-881-88bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43353-881-888dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43353-881-88e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43353-881-889bebd1f3094a…5416666fcb17…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-881-882020-01-31C16284748780-19d75b9d0-6eb0-f424-e053-dadaa90a57ceOndansetron Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-881-88Ondansetron900 in 1 BOTTLETABLET, FILM COATED9001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-881-88EA - Each43353-8819a8bccd7-9bea-4555-8799-6e1ea09c25d212018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-881ONDANSETRON TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20171216_e3331557-ed5a-466e-b174-1debb1938dc3.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-881-8843353088188900 in 1 BOTTLEHistorical