Ondansetron

Product NDC
68071-2763
11-digit product format
680712763
Labeler code
68071
Product ID
68071-2763_2a815b39-7f3d-126e-e063-6394a90a3112
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2021-04-27
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
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
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 · 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 UTC2026-02A090469-001ONDANSETRON4MGTABLET, 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…
2022-03-09 01:35 UTC2022-03A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12782e0a99824c…

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 UTC2026-02A090469-001AB1011fe1cb6892…
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…
2022-03-09 01:35 UTC2022-03A090469-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090469-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090469-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090469-002AB1782e0a99824c…

Additional Listing Data#

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

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
e183c59c-2a7c-dba3-e053-2a95a90acf87Available 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
68071-2763-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102
68071-2763-3Ondansetron30 in 1 CARTONTABLET, ORALLY DISINTEGRATING302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2763ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20250101_e183c59c-2a7c-dba3-e053-2a95a90acf87.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
OndansetronONDANSETRONSportpharm LLC3c4cda2f-13d9-42c5-b449-77deb06c8de52026-02-06Warnings, 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
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.66ac9c17-bea7-4f8d-8a27-a1e0f9e659452025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.70b48280-ef74-472b-abc3-128962bfcb052025-09-03Warnings, 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
OndansetronONDANSETRONRising Pharma Holdings, Inc.eb74425c-c635-4d99-8e98-e63e7359fb892025-07-17Warnings, 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 TabletPSNe183c59c-2a7c-dba3-e053-2a95a90acf872
312087ondansetron 8 MG Disintegrating Oral TabletSCDe183c59c-2a7c-dba3-e053-2a95a90acf872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2763-36807127630330 BLISTER PACK in 1 CARTON (68071-2763-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2022-06-150000-00-00NoNoCurrent