ondansetron hydrochloride

Product NDC
0615-8185
11-digit product format
006158185
Labeler code
0615
Product ID
0615-8185_cb0b89ea-904e-424e-9213-80fc4d073fe3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA076183
Marketing category
ANDA
Marketing start
2006-12-26
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/1
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0615-81850615-8185-50DDiscontinued 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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076183-001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-26
A076183-002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-26
A076183-003ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-26
A076183-004ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076183-002AB
A076183-003AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076183-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076183-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076183-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076183-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076183-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076183-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076183-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076183-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076183-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076183-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076183-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076183-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076183-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076183-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076183-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076183-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076183-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076183-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076183-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076183-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076183-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076183-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076183-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076183-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076183-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076183-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076183-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076183-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076183-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076183-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076183-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076183-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076183-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076183-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076183-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076183-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076183-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076183-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076183-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076183-003AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
ondansetron hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198052Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00327696-c496-4c83-a63e-9e29fd6246d4Available 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
0615-8185-00ondansetron hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED522
0615-8185-05ondansetron hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED1522
0615-8185-10ondansetron hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1022
0615-8185-12ondansetron hydrochloride12 in 1 BLISTER PACKTABLET, FILM COATED1222
0615-8185-39ondansetron hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3022
0615-8185-50ondansetron hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED522

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8185ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]22Current NDC, Legacy NDC, 6 package rows20240426_00327696-c496-4c83-a63e-9e29fd6246d4.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ondansetronONDANSETRON HYDROCHLORIDECardinal Health 107, LLCcb02f2d7-31a9-4f12-880e-7ce7d85440d42026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076183
application number: ANDA076183
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076183
application number: ANDA076183
ondansetronONDANSETRON HYDROCHLORIDEMajor Pharmaceuticalsa29b5c18-9884-4c88-8827-65d9ad5f69f62025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076183
application number: ANDA076183
ONDANSETRONONDANSETRON HYDROCHLORIDEDr. Reddy's Laboratories Limited162f2088-9fb1-47e7-b88c-45104be7e7bb2025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076183
application number: ANDA076183
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs00327696-c496-4c83-a63e-9e29fd6246d42024-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076183
application number: ANDA076183
ndc (product): 0615-8185
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstcdb2c4b4-a20a-3f8f-e053-2a95a90aaf722024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076183
application number: ANDA076183
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDEDr. Reddy's Laboratories Limited476e704c-95ae-4591-94f7-ee4ab827ff132021-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076183
application number: ANDA076183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN00327696-c496-4c83-a63e-9e29fd6246d422
198052ondansetron 4 MG Oral TabletSCD00327696-c496-4c83-a63e-9e29fd6246d422
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY00327696-c496-4c83-a63e-9e29fd6246d422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8185-00006158185005 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00) 2024-04-22NoNoCurrent
0615-8185-050061581850515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05) 2020-03-240000-00-00NoNoCurrent
0615-8185-100061581851010 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10) 2018-11-070000-00-00NoNoCurrent
0615-8185-120061581851212 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12) 2024-01-26NoNoCurrent
0615-8185-390061581853930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39) 2018-11-070000-00-00NoNoCurrent
0615-8185-50006158185505 in 1 BLISTER PACKHistorical