ZUPLENZ

Product NDC: 89141-448
11-digit product format: 891410448
Labeler code: 89141
Product ID: 89141-448_bfc201b4-034f-4472-8082-8a6b808e3ea7
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: 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
89141-448-30	2021-10-20	C162847	48780-1	c7ccaba7-1b6f-fd44-e053-dadaa90aa01b	0b1dab95-b64b-4133-bcad-a65b332ab320
89141-448-30	2021-07-23	C162847	48780-1	c7ccaba7-1b6f-fd44-e053-dadaa90aa01b	0b1dab95-b64b-4133-bcad-a65b332ab320

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
89141-448-01	EA - Each	89141-448	09ade7b6-cf8e-4924-8025-0249f10b166c	1	2017-03-06
89141-448-30	EA - Each	89141-448	660d5a2e-8c15-4464-bbd0-bcf024ebf392	1	2017-03-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4AF302ESOS	ONDANSETRON	99614-02-5	ONDANSETRON

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
89141-448-30	89141044830	30 POUCH in 1 BOX (89141-448-30) > 1 FILM in 1 POUCH (89141-448-01)	30 pouch	2016-12-31	0000-00-00	No	No	Current