Ondansetron

Product NDC
68071-2547
11-digit product format
680712547
Labeler code
68071
Product ID
68071-2547_cd3822a5-6ff3-86dd-e053-2a95a90a4dd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091342
Marketing category
ANDA
Marketing start
2011-01-27
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2547-52023-07-17C16284748780-1f386c649-f9ef-0266-e053-dadaa90a7c1acd3833f4-3cd9-42b0-e053-2995a90a0707
68071-2547-52023-01-30C16284748780-1f386c649-f9ef-0266-e053-dadaa90a7c1acd3833f4-3cd9-42b0-e053-2995a90a0707

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2547-56807125470550 mL in 1 BOTTLE, PLASTIC (68071-2547-5) 50 ml2021-09-300000-00-00NoNoCurrent