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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-952-652025-01-13C16284748780-11030e365-27ce-111a-e063-dadaa90a10e265829f7a-a8c8-4dad-a7df-568904254d49
55700-952-652024-01-30C16284748780-11030e365-27ce-111a-e063-dadaa90a10e265829f7a-a8c8-4dad-a7df-568904254d49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-952-65EA - Each55700-95261ef5aec-192d-4757-bb10-cc7ce349c02012022-03-09

Packages#

Package NDC, 11-digit format, Description table
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