FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
0054-0064
11-digit product format
000540064
Labeler code
0054
Product ID
0054-0064_64864cbd-055c-436b-80cc-a65e6ac6b02d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076960
Marketing category
ANDA
Marketing start
2006-12-26
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
0054-0064-47Ondansetron Hydrochloride1 in 1 CARTONSOLUTION115
0054-0064-47Ondansetron Hydrochloride50 mL in 1 BOTTLE, GLASSSOLUTION5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0064-47ML - Milliliter0054-0064d304d848-2584-4c8a-a3a3-eed203c5762512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602ONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
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
0054-0064ONDANSETRON HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 2 package rows20211125_1a0c4dc6-643e-4ee7-92a9-edb98049a5ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN1a0c4dc6-643e-4ee7-92a9-edb98049a5ba15
312085ondansetron 0.8 MG/ML Oral SolutionSCD1a0c4dc6-643e-4ee7-92a9-edb98049a5ba15
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY1a0c4dc6-643e-4ee7-92a9-edb98049a5ba15
312085ondansetron 4 MG per 5 ML Oral SolutionSY1a0c4dc6-643e-4ee7-92a9-edb98049a5ba15
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
312085ondansetron HCl 4 MG in 5 mL Oral SolutionPSN4bfde0e0-09ff-491f-8f57-838ed04ee13c2
312085ondansetron 0.8 MG/ML Oral SolutionSCD4bfde0e0-09ff-491f-8f57-838ed04ee13c2
312085ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral SolutionSY4bfde0e0-09ff-491f-8f57-838ed04ee13c2
312085ondansetron 4 MG per 5 ML Oral SolutionSY4bfde0e0-09ff-491f-8f57-838ed04ee13c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0064-47000540064471 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS2006-12-260000-00-00NoNoCurrent