Valganciclovir

Product NDC: 42291-875
11-digit product format: 422910875
Labeler code: 42291
Product ID: 42291-875_d5ca21ed-a3f1-b7dd-e053-2a95a90ac112
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA200790
Marketing category: ANDA
Marketing start: 2016-06-21
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
42291-875-60	EA - Each	42291-875	c21e5de7-8139-4d36-8b43-578af086c2f2	1	2016-07-19

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
42291-875-60	42291087560	60 TABLET, FILM COATED in 1 BOTTLE (42291-875-60)	2016-06-21	0000-00-00	No	No	Current