Acyclovir
ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
Approved
Approval ID
67e7b340-0635-2595-e053-2a91aa0ad266
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
YILING PHARMACEUTICAL, INC.
DUNS: 079417422
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 Code69117-0019
Application NumberANDA210401
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (5)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACYCLOVIRActive
Quantity: 800 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB