Ondansetron

Product NDC
55700-952
11-digit product format
557000952
Labeler code
55700
Product ID
55700-952_fa18a658-1dde-4dfd-8dc2-f9e5b119385c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA090469
Marketing category
ANDA
Marketing start
2022-01-11
Marketing end
0000-00-00
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4AF302ESOSONDANSETRON99614-02-5ONDANSETRON

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-952-65557000952653 BLISTER PACK in 1 CARTON (55700-952-65) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2022-01-110000-00-00NoNoCurrent