ZUPLENZ

Product NDC
89141-444
11-digit product format
891410444
Labeler code
89141
Product ID
89141-444_cecd2ac3-8e81-2c9e-e053-2a95a90a8281
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron
Dosage form
FILM
Route
ORAL
Labeler
Fortovia Therapeutics, Inc.
Application
NDA022524
Marketing category
NDA
Marketing start
2010-07-02
Marketing end
2023-02-23
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
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
89141-444-302021-10-20C16284748780-1c7ccaba7-1b6f-fd44-e053-dadaa90aa01b0b1dab95-b64b-4133-bcad-a65b332ab320
89141-444-302021-07-23C16284748780-1c7ccaba7-1b6f-fd44-e053-dadaa90aa01b0b1dab95-b64b-4133-bcad-a65b332ab320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
89141-444-01EA - Each89141-444ca6f8072-6815-4f39-9063-6f5c3fccc84412017-03-06
89141-444-30EA - Each89141-44499209cd9-29c7-44c3-8da4-f5bb302d03dd12017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
89141-444-308914104443030 POUCH in 1 BOX (89141-444-30) > 1 FILM in 1 POUCH (89141-444-01) 30 pouch2016-12-310000-00-00NoNoCurrent