FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
68094-763
11-digit product format
680940763
Labeler code
68094
Product ID
68094-763_058d49ad-8056-4e04-9b29-3e088d9b86d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA076960
Marketing category
ANDA
Marketing start
2015-02-27
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 Hydrochloride
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-763-59Ondansetron Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION55
68094-763-62Ondansetron Hydrochloride3 in 1 CASESOLUTION35
68094-763-62Ondansetron Hydrochloride10 in 1 TRAYSOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-763-59ML - Milliliter68094-763950128e8-e767-4a20-a176-b9c71848e22a12015-04-03
68094-763-62ML - Milliliter68094-763e2f30011-bb76-490c-8c5e-609d6f8d672012015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ondansetron HydrochlorideACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1
OndansetronACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1
saccharin sodium anhydrousINACTIVE INGREDIENTI4807BK602ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-763ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]4Current NDC, Legacy NDC, 3 package rows20240316_04800a86-2391-44e6-8763-d65e8a916c26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN04800a86-2391-44e6-8763-d65e8a916c265
312085ondansetron 0.8 MG/ML Oral SolutionSCD04800a86-2391-44e6-8763-d65e8a916c265
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY04800a86-2391-44e6-8763-d65e8a916c265
312085ondansetron 4 MG per 5 ML Oral SolutionSY04800a86-2391-44e6-8763-d65e8a916c265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-763-59680940763595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-763-62680940763623 TRAY in 1 CASE (68094-763-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-763-59) 3 tray2015-02-270000-00-00NoNoCurrent