acyclovir
ACYCLOVIR TABLETS, USP 400 mg and 800 mg
Approved
Approval ID
b2ae0432-bd2a-1480-e053-2a95a90a6fc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acyclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2287
Application NumberANDA077309
Product Classification
M
Marketing Category
C73584
G
Generic Name
acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2022
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ACYCLOVIRActive
Quantity: 400 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT