ondansetron hydrochloride

Product NDC
55111-155
11-digit product format
551110155
Labeler code
55111
Product ID
55111-155_9064dccd-0ae4-688a-3216-6ced5e514340
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076183
Marketing category
ANDA
Marketing start
2006-12-26
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
16 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076183-001ONDANSETRON HYDROCHLORIDEEQ 24MG BASETABLET / ORAL2006-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076183-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2006-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076183-003ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2006-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076183-004ONDANSETRON HYDROCHLORIDEEQ 16MG BASETABLET / ORAL2006-12-26caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076183-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076183-003AB1caaa826d4ba7…
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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE16 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
692695Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
476e704c-95ae-4591-94f7-ee4ab827ff13Available 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
55111-155-05ondansetron hydrochloride500 in 1 BOTTLETABLET, FILM COATED5003
55111-155-30ondansetron hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
55111-155-78ondansetron hydrochloride10 in 1 CARTONTABLET, FILM COATED103
55111-155-79ondansetron hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ondansetron HydrochlorideACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
OndansetronACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
colloidal silicon dioxideINACTIVE INGREDIENTONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
hypromelloseINACTIVE INGREDIENTONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
lactose monohydrateINACTIVE INGREDIENTONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
microcrystalline celluloseINACTIVE INGREDIENTONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
polyethylene glycolINACTIVE INGREDIENTONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
pregelatinized starchINACTIVE INGREDIENTONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
sodium starch glycolateINACTIVE INGREDIENTONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-155ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]3Current NDC, Legacy NDC, 4 package rows20210604_476e704c-95ae-4591-94f7-ee4ab827ff13.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
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
ndc (product): 55111-155

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692695ondansetron HCl 16 MG Oral TabletPSN476e704c-95ae-4591-94f7-ee4ab827ff133
692695ondansetron 16 MG Oral TabletSCD476e704c-95ae-4591-94f7-ee4ab827ff133
692695ondansetron (as ondansetron hydrochloride dihydrate) 16 MG Oral TabletSY476e704c-95ae-4591-94f7-ee4ab827ff133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-155-0555111015505500 TABLET, FILM COATED in 1 BOTTLE (55111-155-05) 2006-12-260000-00-00NoNoCurrent
55111-155-305511101553030 TABLET, FILM COATED in 1 BOTTLE (55111-155-30) 2006-12-260000-00-00NoNoCurrent
55111-155-785511101557810 BLISTER PACK in 1 CARTON (55111-155-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-155-79) 10 blister pack2006-12-260000-00-00NoNoCurrent
55111-155-795511101557910 in 1 BLISTER PACKHistorical