Ondansetron

Product NDC
0121-0882
11-digit product format
001210882
Labeler code
0121
Product ID
0121-0882_4aa77c21-9d0a-4d33-ace6-0be0a64a1f15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA078127
Marketing category
ANDA
Marketing start
2026-04-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/5mL

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
0121-0882-51Ondansetron50 mL in 1 BOTTLE, PLASTICSOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0882-51ML - Milliliter0121-08829968a15c-9210-4aa8-a175-33974a20263d12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN68a4d845-0c1c-4867-bfca-c0fb11dc93cd1
312085ondansetron 0.8 MG/ML Oral SolutionSCD68a4d845-0c1c-4867-bfca-c0fb11dc93cd1
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY68a4d845-0c1c-4867-bfca-c0fb11dc93cd1
312085ondansetron 4 MG per 5 ML Oral SolutionSY68a4d845-0c1c-4867-bfca-c0fb11dc93cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-0882-510012108825150 mL in 1 BOTTLE, PLASTIC (0121-0882-51) 50 ml2026-04-20NoNoHistorical