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Acyclovir

ACYCLOVIRCAPSULES USPACYCLOVIRTABLETS USP894089438947Rx only

Approved
Approval ID

c48d04a4-e8ca-4948-a2ff-b45ea44b49b0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 29, 2011

Manufacturers
FDA

Blenheim Pharmacal, Inc.

DUNS: 171434587

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 Code10544-102
Application NumberANDA074556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2011
FDA Product Classification

INGREDIENTS (8)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACYCLOVIRActive
Quantity: 400 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

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Acyclovir - FDA Drug Approval Details