ondansetron hydrochloride

Product NDC
62756-130
11-digit product format
627560130
Labeler code
62756
Product ID
62756-130_e83d90db-54a7-4c13-bd68-b1620a8aecaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077050
Marketing category
ANDA
Marketing start
2007-06-25
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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077050-001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25
A077050-002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 8MG 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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2007-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORAL2007-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077050-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A077050-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077050-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077050-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077050-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077050-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077050-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077050-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077050-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077050-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077050-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077050-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077050-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077050-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077050-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077050-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077050-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077050-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077050-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077050-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077050-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077050-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077050-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077050-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077050-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077050-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077050-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077050-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077050-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077050-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077050-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077050-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077050-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077050-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077050-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077050-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077050-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077050-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077050-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077050-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077050-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077050-002AB1ea99ee380514…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4AF302ESOSInternal UNII lookup
NMH84OZK2BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
104894Internal RxNorm lookup
198052Internal RxNorm lookup
312086Internal RxNorm lookup
312087Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92c758a3-e749-4a15-be4b-ee30b364b2b0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-130-01ondansetron hydrochloride30 in 1 BOTTLETABLET, FILM COATED3018
62756-130-02ondansetron hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1018
62756-130-02ondansetron hydrochloride10 in 1 DOSE PACKTABLET, FILM COATED1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-130-01EA - Each62756-1307ce75d6e-297b-4024-ab7b-c2d94e17549812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-130ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]17Current NDC, Legacy NDC, 3 package rows20250419_92c758a3-e749-4a15-be4b-ee30b364b2b0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDESun Pharmaceutical Industries, Inc.92c758a3-e749-4a15-be4b-ee30b364b2b02025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077050
application number: ANDA077050
ndc (product): 62756-130

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
312087ondansetron 8 MG Disintegrating Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
198052ondansetron HCl 4 MG Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
312086ondansetron HCl 8 MG Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
104894ondansetron 4 MG Disintegrating Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
198052ondansetron 4 MG Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
312087ondansetron 8 MG Disintegrating Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
312086ondansetron 8 MG Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY92c758a3-e749-4a15-be4b-ee30b364b2b018
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY92c758a3-e749-4a15-be4b-ee30b364b2b018
312087ondansetron 8 MG Disintegrating Oral TabletPSN384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
198052ondansetron HCl 4 MG Oral TabletPSN384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
198052ondansetron 4 MG Oral TabletSCD384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
312087ondansetron 8 MG Disintegrating Oral TabletSCD384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
198052ondansetron HCl 4 MG Oral TabletPSN69b9a032-f2d1-4c5a-a35e-9cdc3c6207165
312086ondansetron HCl 8 MG Oral TabletPSN69b9a032-f2d1-4c5a-a35e-9cdc3c6207165
198052ondansetron 4 MG Oral TabletSCD69b9a032-f2d1-4c5a-a35e-9cdc3c6207165
312086ondansetron 8 MG Oral TabletSCD69b9a032-f2d1-4c5a-a35e-9cdc3c6207165
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY69b9a032-f2d1-4c5a-a35e-9cdc3c6207165
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY69b9a032-f2d1-4c5a-a35e-9cdc3c6207165
198052ondansetron HCl 4 MG Oral TabletPSN2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron HCl 4 MG Oral TabletPSNbadebfae-8a97-419f-bb47-dcd72dcfabe42
312086ondansetron HCl 8 MG Oral TabletPSN2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron 4 MG Oral TabletSCD2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron 4 MG Oral TabletSCDbadebfae-8a97-419f-bb47-dcd72dcfabe42
312086ondansetron 8 MG Oral TabletSCD2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYbadebfae-8a97-419f-bb47-dcd72dcfabe42
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2e57105a-b925-4182-9f70-d0fa0e6130512
198052ondansetron HCl 4 MG Oral TabletPSNc5378585-dd35-4123-82b9-91395b56c3eb1
312086ondansetron HCl 8 MG Oral TabletPSNc5378585-dd35-4123-82b9-91395b56c3eb1
198052ondansetron 4 MG Oral TabletSCDc5378585-dd35-4123-82b9-91395b56c3eb1
312086ondansetron 8 MG Oral TabletSCDc5378585-dd35-4123-82b9-91395b56c3eb1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYc5378585-dd35-4123-82b9-91395b56c3eb1
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYc5378585-dd35-4123-82b9-91395b56c3eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-130-016275601300130 TABLET, FILM COATED in 1 BOTTLE (62756-130-01) 2007-06-250000-00-00NoNoCurrent
62756-130-026275601300210 BLISTER PACK in 1 DOSE PACK (62756-130-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2007-06-250000-00-00NoNoCurrent