Valganciclovir

Product NDC: 0603-6330
11-digit product format: 006036330
Labeler code: 0603
Product ID: 0603-6330_2ef2c711-9b0e-42fa-aa3e-58797bc86a33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical
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 [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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
0603-6330-20	EA - Each	0603-6330	8eba9d72-6638-496b-a126-d8d9640827fe	1	2014-12-01

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
0603-6330-20	00603633020	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6330-20)	2014-11-04	0000-00-00	No	No	Current