VALACYCLOVIR HYDROCHLORIDE
1147 VALACYCLOVIR HCL 500MG
Approved
Approval ID
8f8b0fb5-cbeb-da8f-e053-2a95a90ae241
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2019
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VALACYCLOVIR HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76519-1147
Application NumberANDA077135
Product Classification
M
Marketing Category
C73584
G
Generic Name
VALACYCLOVIR HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2019
FDA Product Classification
INGREDIENTS (1)
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: G447S0T1VC
Classification: ACTIR