FDA Product

Acyclovir

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Acyclovir

FDA Product Code

68788-8203

Regulatory Information

NDC Product Code

68788-8203

Application Number

ANDA209366

Marketing Category

C73584

Effective Date

January 18, 2024

Territorial Authority

USA

FDA Title

Acyclovir Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerPreferred Pharmaceuticals Inc.

DUNS Number

791119022

Active Ingredients

Quantity: 400 mg in 1 1

Code: X4HES1O11F

Class Code: ACTIB

Inactive Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

ACYCLOVIR

Code: X4HES1O11F

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