MedPath

Acyclovir

ACYCLOVIR ORAL SUSPENSION, USP

Approved
Approval ID

47a4af6e-1111-458b-9a79-2199b78d8a80

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 11, 2022

Manufacturers
FDA

VistaPharm, Inc.

DUNS: 116743084

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 Code66689-342
Application NumberANDA213951
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2022
FDA Product Classification

INGREDIENTS (8)

CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ACYCLOVIRActive
Quantity: 200 mg in 5 mL
Code: X4HES1O11F
Classification: ACTIB

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