Valganciclovir

Product NDC: 16714-765
11-digit product format: 167140765
Labeler code: 16714
Product ID: 16714-765_d66fef85-c126-b5a3-38ba-a9d3b6370b5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA203511
Marketing category: ANDA
Marketing start: 2018-03-10
Marketing end: 0000-00-00
Substance: VALGANCICLOVIR HYDROCHLORIDE
Active strength: 450 mg/1
Pharmacologic classes: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-765-01	EA - Each	16714-765	492e46a7-b290-479f-9cd4-5c0ce7902cac	1	2018-04-19

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4P3T9QF9NZ	VALGANCICLOVIR HYDROCHLORIDE	175865-59-5	VALGANCICLOVIR HYDROCHLORIDE
GCU97FKN3R	VALGANCICLOVIR	175865-60-8	Valganciclovir

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-765-01	16714076501	60 TABLET, FILM COATED in 1 BOTTLE (16714-765-01)	2018-03-10	0000-00-00	No	No	Current