Ondansetron

Product NDC
71335-3073
11-digit product format
713353073
Labeler code
71335
Product ID
71335-3073_0d5d8d59-324c-4cf7-bc19-bc4d208bef05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090469-001ONDANSETRONONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12
A090469-002ONDANSETRONONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090469-001AB
A090469-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-1284e616aacf4f…
2026-08-18 06:07:402026-07A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-1274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090469-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090469-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090469-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090469-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090469-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090469-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090469-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090469-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090469-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090469-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090469-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090469-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090469-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090469-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090469-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090469-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090469-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090469-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090469-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090469-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090469-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090469-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090469-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090469-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090469-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090469-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090469-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090469-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090469-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090469-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090469-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090469-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090469-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090469-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090469-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090469-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090469-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090469-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090469-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090469-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
77397df5-5a4f-41b2-98bc-f817a1e497fcAvailable 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
71335-3073-1Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING301
71335-3073-2Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING101
71335-3073-3Ondansetron9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING91
71335-3073-4Ondansetron5 in 1 BOTTLETABLET, ORALLY DISINTEGRATING51
71335-3073-5Ondansetron3 in 1 BOTTLETABLET, ORALLY DISINTEGRATING31
71335-3073-6Ondansetron6 in 1 BOTTLETABLET, ORALLY DISINTEGRATING61
71335-3073-7Ondansetron12 in 1 BOTTLETABLET, ORALLY DISINTEGRATING121
71335-3073-8Ondansetron4 in 1 BOTTLETABLET, ORALLY DISINTEGRATING41

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONAsclemed USA, Inc.269c920c-643a-4eea-9bf9-b1f008915db92026-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.66ac9c17-bea7-4f8d-8a27-a1e0f9e659452026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.70b48280-ef74-472b-abc3-128962bfcb052026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONSportpharm LLC3c4cda2f-13d9-42c5-b449-77deb06c8de52026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONHAWAII REPACK, INC.b76c5cc9-f1ca-428b-8989-36a66802b6502026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONREMEDYREPACK INC.18063a64-a4c0-4bad-911b-00df5c7bb65d2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONBryant Ranch Prepack77397df5-5a4f-41b2-98bc-f817a1e497fc2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
ndc (product): 71335-3073
OndansetronONDANSETRONSportpharm LLC822404ad-af08-4c62-ae38-7d9819e860792026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONSt. Mary's Medical Park Pharmacy3207cf04-73b7-24ce-e054-00144ff8d46c2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
ONDANSETRONONDANSETRONDirect Rxb38feff2-900a-4e0c-8260-8f090edbc0bc2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONA-S Medication Solutions378d0963-d026-4478-8202-fbb636904a372026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.9dff6676-e69e-779d-e053-2995a90a7c812026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.76666e7e-3312-6f9d-e053-2991aa0af7052026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNorthwind Health Company, LLCf2b502e2-03ed-fe5c-e053-2995a90a368e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNorthwind Health Company, LLCdb9a0d22-9339-4319-e053-2a95a90a95922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNorthwind Health Company, LLCe07c38c0-e1c2-01de-e053-2995a90a390a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.9558d296-8edd-4aa1-875a-6247f9a8374d2025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.10afd68b-877f-4819-a314-39f2d56d5db92025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da2025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONCardinal Health 107, LLCb50c1767-8a50-49ab-be31-6533021ae7c42025-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN77397df5-5a4f-41b2-98bc-f817a1e497fc1
312087ondansetron 8 MG Disintegrating Oral TabletSCD77397df5-5a4f-41b2-98bc-f817a1e497fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3073-07133530730014 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-0) 2026-02-09NoNoCurrent
71335-3073-17133530730130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-1) 2026-02-09NoNoCurrent
71335-3073-27133530730210 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-2) 2026-02-09NoNoCurrent
71335-3073-3713353073039 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-3) 2026-02-09NoNoCurrent
71335-3073-4713353073045 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-4) 2026-02-09NoNoCurrent
71335-3073-5713353073053 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-5) 2026-02-09NoNoCurrent
71335-3073-6713353073066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-6) 2026-02-09NoNoCurrent
71335-3073-77133530730712 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-7) 2026-02-09NoNoCurrent
71335-3073-8713353073084 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-8) 2026-02-09NoNoCurrent
71335-3073-97133530730920 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-9) 2026-02-09NoNoCurrent