ONDANSETRON

Product NDC
63187-065
11-digit product format
631870065
Labeler code
63187
Product ID
63187-065_dcd5d6d3-2419-467f-91c2-50586e9ca5cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
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
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
A077851-001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25
A077851-002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077851-001AB
A077851-002AB

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 UTC2026-02A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077851-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077851-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077851-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077851-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077851-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077851-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077851-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077851-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077851-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077851-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077851-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077851-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077851-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077851-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077851-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077851-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077851-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077851-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077851-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077851-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077851-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077851-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077851-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077851-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077851-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077851-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077851-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077851-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077851-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077851-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077851-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077851-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077851-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077851-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077851-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077851-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077851-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077851-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077851-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077851-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41c0dc3d-a616-425e-9073-625a0cb692c4Available 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
63187-065-10ONDANSETRON10 in 1 BOTTLETABLET, FILM COATED104
63187-065-15ONDANSETRON15 in 1 BOTTLETABLET, FILM COATED154
63187-065-20ONDANSETRON20 in 1 BOTTLETABLET, FILM COATED204
63187-065-30ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED304
63187-065-60ONDANSETRON60 in 1 BOTTLETABLET, FILM COATED604
63187-065-90ONDANSETRON90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-065-30EA - Each63187-065e87d79f9-6687-4093-9617-345aa7c6e2e812016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-065ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20191122_41c0dc3d-a616-425e-9073-625a0cb692c4.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ondansetronONDANSETRON HYDROCHLORIDEAscend Laboratories, LLC2edc0788-dc38-4d21-ba8e-71f159e2d3b12026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
OndansetronONDANSETRONREMEDYREPACK INC.36592150-7e19-474c-9f96-cc8341e28b5d2026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
OndansetronONDANSETRONGolden State Medical Supply, Inc.2b9ea1fc-59a4-8189-e063-6394a90a9ae62026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
OndansetronONDANSETRONNatco Pharma USA LLC64527de5-0b92-4340-9243-7a37e8ff96d92025-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
OndansetronONDANSETRONBryant Ranch Prepackf08f56de-8678-4da9-8cae-013a5c3934532024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
OndansetronONDANSETRON TABLETSNatco Pharma Limited59c817b7-a1c6-48a5-9bfc-2c381532bfd92021-11-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
ondansetronONDANSETRON HYDROCHLORIDEProficient Rx LPbde7c22c-0047-4735-8df6-b48e8dfa478a2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
ONDANSETRONONDANSETRONProficient Rx LP41c0dc3d-a616-425e-9073-625a0cb692c42019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
ndc (product): 63187-065
ONDANSETRONONDANSETRONSun Pharmaceutical Industries, Inc.834bc56a-657d-4733-9a60-47040cb5c7bf2019-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851
ondansetronONDANSETRON HYDROCHLORIDEBryant Ranch Prepack37de0550-a6d1-46a8-a0b8-447b0dcf70ad2019-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077851
application number: ANDA077851

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron HCl 8 MG Oral TabletPSN41c0dc3d-a616-425e-9073-625a0cb692c44
198052ondansetron 4 MG Oral TabletSCD41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron 8 MG Oral TabletSCD41c0dc3d-a616-425e-9073-625a0cb692c44
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY41c0dc3d-a616-425e-9073-625a0cb692c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-065-106318700651010 TABLET, FILM COATED in 1 BOTTLE (63187-065-10) 2014-04-010000-00-00NoNoCurrent
63187-065-156318700651515 TABLET, FILM COATED in 1 BOTTLE (63187-065-15) 2014-04-010000-00-00NoNoCurrent
63187-065-206318700652020 TABLET, FILM COATED in 1 BOTTLE (63187-065-20) 2014-04-010000-00-00NoNoCurrent
63187-065-306318700653030 TABLET, FILM COATED in 1 BOTTLE (63187-065-30) 2014-04-010000-00-00NoNoCurrent
63187-065-606318700656060 TABLET, FILM COATED in 1 BOTTLE (63187-065-60) 2014-04-010000-00-00NoNoCurrent
63187-065-906318700659090 TABLET, FILM COATED in 1 BOTTLE (63187-065-90) 2014-04-010000-00-00NoNoCurrent