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Acyclovir

Acyclovir Tablets, USP Rx only

Approved
Approval ID

8fb01f23-e2bd-6850-e053-2995a90a7cc5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 9, 2022

Manufacturers
FDA

PharmPak, Inc.

DUNS: 175493840

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acyclovir

PRODUCT DETAILS

NDC Product Code54348-627
Application NumberANDA203834
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 9, 2022
Generic NameAcyclovir

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ACYCLOVIRActive
Quantity: 400 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB

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Acyclovir - FDA Drug Approval Details