Valganciclovir

Product NDC: 48433-124
11-digit product format: 484330124
Labeler code: 48433
Product ID: 48433-124_3ae4c7b1-fef2-40c6-96bb-5571ae249064
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valganciclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA203511
Marketing category: ANDA
Marketing start: 2019-05-08
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
48433-124-10	2022-01-30	C162847	48780-1	d6a99b39-9e88-a426-e053-dadaa90af4c2	d04ad795-a5ff-42f8-aa8e-52d7fcf9293b
48433-124-10	2022-01-28	C162847	48780-1	d6a99b39-9e88-a426-e053-dadaa90af4c2	d04ad795-a5ff-42f8-aa8e-52d7fcf9293b

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
48433-124-10	48433012410	1 BLISTER PACK in 1 BOX (48433-124-10) > 100 TABLET, FILM COATED in 1 BLISTER PACK (48433-124-01)	1 blister pack	2019-05-08	0000-00-00	No	No	Current