Valganciclovir

Product NDC: 69097-277
11-digit product format: 690970277
Labeler code: 69097
Product ID: 69097-277_2871b2cf-f96d-420e-8874-1a25d12d8858
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA209672
Marketing category: ANDA
Marketing start: 2018-11-12
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
69097-277-03	EA - Each	69097-277	7d471a9a-bfe4-4a8c-89bc-8dda2df37ead	1	2019-01-24

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
69097-277-03	69097027703	60 TABLET in 1 BOTTLE (69097-277-03)	60 tablet	2018-11-12	0000-00-00	No	No	Current