Ondansetron

Product NDC
71335-0132
11-digit product format
713350132
Labeler code
71335
Product ID
71335-0132_aba5e1a7-a00a-4e76-b0e3-dfbe4179eec0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-07-27
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 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077851-001ONDANSETRON HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2007-06-25caaa826d4ba7…
2026-08-18 06:07:402026-07A077851-002ONDANSETRON HYDROCHLORIDEEQ 8MG BASETABLET / ORALAB2007-06-25caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077851-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077851-002AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
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
f08f56de-8678-4da9-8cae-013a5c393453Available 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
71335-0132-0Ondansetron60 in 1 BOTTLETABLET, FILM COATED604
71335-0132-1Ondansetron10 in 1 BOTTLETABLET, FILM COATED104
71335-0132-2Ondansetron3 in 1 BOTTLETABLET, FILM COATED34
71335-0132-3Ondansetron30 in 1 BOTTLETABLET, FILM COATED304
71335-0132-4Ondansetron15 in 1 BOTTLETABLET, FILM COATED154
71335-0132-5Ondansetron6 in 1 BOTTLETABLET, FILM COATED64
71335-0132-6Ondansetron4 in 1 BOTTLETABLET, FILM COATED44
71335-0132-7Ondansetron90 in 1 BOTTLETABLET, FILM COATED904
71335-0132-8Ondansetron12 in 1 BOTTLETABLET, FILM COATED124
71335-0132-9Ondansetron20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0132ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20241004_f08f56de-8678-4da9-8cae-013a5c393453.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
ndc (product): 71335-0132
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
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 TabletPSNf08f56de-8678-4da9-8cae-013a5c3934534
198052ondansetron 4 MG Oral TabletSCDf08f56de-8678-4da9-8cae-013a5c3934534
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYf08f56de-8678-4da9-8cae-013a5c3934534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0132-07133501320060 TABLET, FILM COATED in 1 BOTTLE (71335-0132-0) 2014-04-030000-00-00NoNoCurrent
71335-0132-17133501320110 TABLET, FILM COATED in 1 BOTTLE (71335-0132-1) 2014-04-030000-00-00NoNoCurrent
71335-0132-2713350132023 TABLET, FILM COATED in 1 BOTTLE (71335-0132-2) 2014-04-030000-00-00NoNoCurrent
71335-0132-37133501320330 TABLET, FILM COATED in 1 BOTTLE (71335-0132-3) 2014-04-030000-00-00NoNoCurrent
71335-0132-47133501320415 TABLET, FILM COATED in 1 BOTTLE (71335-0132-4) 2014-04-030000-00-00NoNoCurrent
71335-0132-5713350132056 TABLET, FILM COATED in 1 BOTTLE (71335-0132-5) 2014-04-030000-00-00NoNoCurrent
71335-0132-6713350132064 TABLET, FILM COATED in 1 BOTTLE (71335-0132-6) 2014-04-030000-00-00NoNoCurrent
71335-0132-77133501320790 TABLET, FILM COATED in 1 BOTTLE (71335-0132-7) 2014-04-030000-00-00NoNoCurrent
71335-0132-87133501320812 TABLET, FILM COATED in 1 BOTTLE (71335-0132-8) 2014-04-030000-00-00NoNoCurrent
71335-0132-97133501320920 TABLET, FILM COATED in 1 BOTTLE (71335-0132-9) 2014-04-030000-00-00NoNoCurrent