Acyclovir
Acyclovir Tablets USP
Approved
Approval ID
a68e610a-841c-4b69-9233-673d060561e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2022
Manufacturers
FDA
Carlsbad Technology, Inc.
DUNS: 781047246
Products 2
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 Code61442-112
Application NumberANDA075382
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ACYCLOVIRActive
Quantity: 400 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
Acyclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-113
Application NumberANDA075382
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACYCLOVIRActive
Quantity: 800 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB