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
8542495c-eef1-448b-abb5-83cb1ac589f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 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 Code69117-0039
Application NumberANDA212173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (14)
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACYCLOVIRActive
Quantity: 200 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB