Valganciclovir

Product NDC: 63629-2288
11-digit product format: 636292288
Labeler code: 63629
Product ID: 63629-2288_bc774b63-3e99-4da9-ba33-12c86dd928b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA200790
Marketing category: ANDA
Marketing start: 2014-11-04
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
63629-2288-1	EA - Each	63629-2288	b1390d5f-68ca-4805-bb80-7a54d1b80530	1	2021-05-05

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2288-1	63629228801	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-2288-1)	2021-03-29	0000-00-00	No	No	Current