Ondansetron

Product NDC
43063-592
11-digit product format
430630592
Labeler code
43063
Product ID
43063-592_a8d9e148-9012-6ed1-e053-2995a90ac2a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078050
Marketing category
ANDA
Marketing start
2007-08-13
Marketing end
0000-00-00
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-592-04EA - Each43063-592206d9aee-e2a2-4f0b-a54f-e178d063c52612018-02-20
43063-592-10EA - Each43063-59280afb45f-e6b6-46ca-8d93-473f3a2c650012015-09-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-592-04430630592044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-592-04) 2017-12-260000-00-00NoNoCurrent
43063-592-104306305921010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-592-10) 2014-12-040000-00-00NoNoCurrent