Ondansetron

Product NDC
50090-1658
11-digit product format
500901658
Labeler code
50090
Product ID
50090-1658_b108bb68-c81b-48a3-876b-e0280f726a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
Substance
ONDANSETRON
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
A078152-001ONDANSETRONONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27
A078152-002ONDANSETRONONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078152-001AB
A078152-002AB

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 UTC2026-02A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27782e0a99824c…

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 UTC2026-02A078152-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078152-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078152-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078152-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078152-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078152-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078152-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078152-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078152-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078152-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078152-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078152-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078152-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078152-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078152-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078152-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078152-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078152-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078152-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078152-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078152-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078152-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078152-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078152-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078152-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078152-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078152-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078152-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078152-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078152-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078152-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078152-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078152-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078152-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078152-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078152-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078152-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078152-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078152-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078152-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
104894Internal 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
5a81a39b-051b-414e-a6b0-d844de4e9ab4Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-1658-02023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-02023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-02023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-12023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-12023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-12023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-22023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-22023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-22023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-32023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-32023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-32023-03-16These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-02023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-02023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-02023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-12023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-12023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-12023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-22023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-22023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-22023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-32023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-32023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-32023-01-30These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1658-0Ondansetron1 in 1 PACKETTABLET, ORALLY DISINTEGRATING121
50090-1658-0Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1021
50090-1658-1Ondansetron1 in 1 PACKETTABLET, ORALLY DISINTEGRATING121
50090-1658-1Ondansetron20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING2021
50090-1658-2Ondansetron5 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING521
50090-1658-2Ondansetron1 in 1 PACKAGETABLET, ORALLY DISINTEGRATING121
50090-1658-3Ondansetron30 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1658-0EA - Each50090-1658017e302b-d747-4f1e-8319-76e834c7a70112018-11-06
50090-1658-1EA - Each50090-16580893feae-0043-4f4d-b8d7-2c122231d97f12018-08-13
50090-1658-2EA - Each50090-16584ddeecd5-83b4-4a7c-a788-f82737f8a1b312018-08-13
50090-1658-3EA - Each50090-1658a87e82db-4edc-4694-b741-4ce1575f5b2812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1658ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 7 package rows20230518_5a81a39b-051b-414e-a6b0-d844de4e9ab4.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONA-S Medication Solutions5a81a39b-051b-414e-a6b0-d844de4e9ab42026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
ndc (product): 50090-1658
OndansetronONDANSETRONA-S Medication Solutions02ddd5f5-76d3-4f1c-9af3-d39e05a19c292026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONSt. Mary's Medical Park Pharmacy41366a20-0727-0446-e063-6294a90a957f2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONREMEDYREPACK INC.9c3ad9c1-474e-4331-a017-09cec46702d82026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc4575d288-be0c-f6c3-e063-6294a90af7082026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONCardinal Health 107, LLC3c34ca82-9705-4784-be7c-8b50351d14fc2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONPreferred Pharmaceuticals Inc.e87a5803-e872-43f7-8a15-79aa236e8c072026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONBluePoint Laboratoriesed1132ec-c2cd-4646-b69d-26663bb937a42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONREMEDYREPACK INC.c0d827d0-333f-4187-ac75-9dc7d34b61692026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.5bacb621-1261-25d9-e053-2991aa0afa3b2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.df736abd-9cec-4e90-e053-2995a90aab5e2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.50383ef5-6e6e-63a7-e054-00144ff88e882026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.ef6ce203-4ae3-19c9-e053-2995a90af7962026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.d117de5f-64e5-464c-b782-de0f07e66c8e2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONGlenmark Pharmaceuticals Inc., USAeee5217a-eba8-463a-812d-bf3c66f0934f2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNorthwind Health Company, LLCf29f5cfa-3cc4-7d53-e053-2995a90ae8442025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONST. MARY'S MEDICAL PARK PHARMACYf175a336-433b-7ab2-e053-2995a90ad5ca2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONAvKARE352de988-d166-c2d8-e063-6294a90acc012025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONProficient Rx LP81366c85-c6c9-4a9a-9fe5-cdd8c2d19f742025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONPreferred Pharmaceuticals Inc.7975d78c-9bb6-467a-9c2d-ea15bde7af5c2025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN5a81a39b-051b-414e-a6b0-d844de4e9ab421
312087ondansetron 8 MG Disintegrating Oral TabletPSN5a81a39b-051b-414e-a6b0-d844de4e9ab421
104894ondansetron 4 MG Disintegrating Oral TabletSCD5a81a39b-051b-414e-a6b0-d844de4e9ab421
312087ondansetron 8 MG Disintegrating Oral TabletSCD5a81a39b-051b-414e-a6b0-d844de4e9ab421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1658-0500901658001 BLISTER PACK in 1 PACKET (50090-1658-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-01-230000-00-00NoNoCurrent
50090-1658-1500901658011 BLISTER PACK in 1 PACKET (50090-1658-1) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-01-230000-00-00NoNoCurrent
50090-1658-2500901658021 BLISTER PACK in 1 PACKAGE (50090-1658-2) / 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-01-23NoNoCurrent
50090-1658-35009016580330 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (50090-1658-3) 2017-01-160000-00-00NoNoCurrent