Valganciclovir

Product NDC: 63739-076
11-digit product format: 637390076
Labeler code: 63739
Product ID: 63739-076_e23418f8-cb6d-17d3-e053-2995a90a2256
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: McKesson Corporation DBA SKY Packaging
Application: ANDA205166
Marketing category: ANDA
Marketing start: 2022-03-07
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
63739-076-33	EA - Each	63739-076	9dbf094f-ecd7-4155-a682-fe9e5eaade89	1	2022-04-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-076	VALGANCICLOVIR TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]	9	Legacy NDC	20250115_d9b7ccf8-aec2-9f48-e053-2a95a90a5d04.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-076-33	63739007633	3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-076-33) > 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2022-03-07	0000-00-00	No	No	Current