Ondansetron Hydrochloride

Product NDC
68999-555
11-digit product format
689990555
Labeler code
68999
Product ID
68999-555_47d4671a-9faa-ece1-e063-6394a90aaa24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA091342
Marketing category
ANDA
Marketing start
2011-01-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-555-24Ondansetron Hydrochloride10 in 1 TRAYSOLUTION101
68999-555-24Ondansetron Hydrochloride2 in 1 BOXSOLUTION21
68999-555-45Ondansetron Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-555-24ML - Milliliter68999-55506d7aed0-5e8e-46b1-bec0-f6482025a9d912026-03-17
68999-555-45ML - Milliliter68999-55573c8bcd0-2fc3-44d7-85b0-a3a9db06ad1812026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN7e862601-1d8a-455b-8ce5-1a32478b309f1
312085ondansetron 0.8 MG/ML Oral SolutionSCD7e862601-1d8a-455b-8ce5-1a32478b309f1
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY7e862601-1d8a-455b-8ce5-1a32478b309f1
312085ondansetron 4 MG per 5 ML Oral SolutionSY7e862601-1d8a-455b-8ce5-1a32478b309f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-555-24689990555242 TRAY in 1 BOX (68999-555-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68999-555-45) 2 tray2026-01-06NoNoHistorical
68999-555-45689990555455 mL in 1 CUP, UNIT-DOSE5 mlHistorical