FDA.reportPublic FDA data

Ondansetron

Product NDC
17856-0691
11-digit product format
178560691
Labeler code
17856
Product ID
17856-0691_3633ef65-d53d-4728-e063-6394a90a6205
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091483
Marketing category
ANDA
Marketing start
2010-12-17
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/5mL
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312085

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0691-12024-04-17C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-22024-04-17C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-42024-04-17C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-52024-04-17C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-62024-04-17C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-72024-04-17C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-82024-04-17C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-12023-01-30C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-22023-01-30C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-42023-01-30C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-52023-01-30C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-62023-01-30C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-72023-01-30C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991
17856-0691-82023-01-30C16284748780-1f386c649-f4b4-0266-e053-dadaa90a7c1aONDANSETRON ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONDANSETRON ORAL SOLUTION safely and effectively. See full prescribing information for ONDANSETRON ORAL SOLUTION. ONDANSETRON ORAL SOLUTION Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0691-1Ondansetron1.5 mL in 1 SYRINGESOLUTION1.515
17856-0691-2Ondansetron2.5 mL in 1 SYRINGE, PLASTICSOLUTION2.515
17856-0691-4Ondansetron2.5 mL in 1 SYRINGE, PLASTICSOLUTION2.515
17856-0691-5Ondansetron5 mL in 1 CUPSOLUTION515
17856-0691-6Ondansetron1.25 mL in 1 SYRINGESOLUTION1.2515
17856-0691-6Ondansetron120 in 1 BOX, UNIT-DOSESOLUTION12015
17856-0691-7Ondansetron1.9 mL in 1 SYRINGESOLUTION1.915
17856-0691-7Ondansetron48 in 1 BOX, UNIT-DOSESOLUTION4815
17856-0691-8Ondansetron2.5 mL in 1 SYRINGESOLUTION2.515
17856-0691-8Ondansetron60 in 1 BOX, UNIT-DOSESOLUTION6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0691-5ML - Milliliter17856-0691e634bb62-3837-4cb3-a576-1d4159874c7f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0691ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORP.]13Current NDC, Legacy NDC, 10 package rows20250524_e5ab38a2-5921-4320-a313-e0080c078046.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSNe5ab38a2-5921-4320-a313-e0080c07804615
312085ondansetron 0.8 MG/ML Oral SolutionSCDe5ab38a2-5921-4320-a313-e0080c07804615
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSYe5ab38a2-5921-4320-a313-e0080c07804615
312085ondansetron 4 MG per 5 ML Oral SolutionSYe5ab38a2-5921-4320-a313-e0080c07804615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0691-1178560691011.5 mL in 1 SYRINGE (17856-0691-1) 1.5 ml2024-04-170000-00-00NoNoCurrent
17856-0691-2178560691022.5 mL in 1 SYRINGE, PLASTIC (17856-0691-2) 2.5 ml2024-04-170000-00-00NoNoCurrent
17856-0691-4178560691042.5 mL in 1 SYRINGE, PLASTIC (17856-0691-4) 2.5 ml2024-04-170000-00-00NoNoCurrent
17856-0691-5178560691055 mL in 1 CUP (17856-0691-5) 5 ml2024-04-170000-00-00NoNoCurrent
17856-0691-617856069106120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-6) / 1.25 mL in 1 SYRINGE120 syringe2024-04-170000-00-00NoNoCurrent
17856-0691-71785606910748 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-7) / 1.9 mL in 1 SYRINGE48 syringe2024-04-170000-00-00NoNoCurrent
17856-0691-81785606910860 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-8) / 2.5 mL in 1 SYRINGE60 syringe2024-04-170000-00-00NoNoCurrent