FDA.reportPublic FDA data

X

Manufacturer
AX Pharmaceutical Corp
Effective date
2016-12-21
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:22

Label at a glance#

ProductX
Active ingredientFAMCICLOVIR
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1005b6ff-d0c1-48ab-8c99-f6ab62104661Product name220250401
39b4c6c3-4107-094f-96fa-0d1c48033493Product name220150326

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62157-379-01X500 g in 1 JARPOWDER5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62157-379X (FAMCICLOVIR) POWDER [AX PHARMACEUTICAL CORP]11 package rows20161222_feb5dae2-d36f-48da-a73f-8e668a309cd9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-37962157-379-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
FAMCICLOVIRQIC03ANI02ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamciclovirFAMCICLOVIRAvKARE5723f50e-b0fa-65f0-e063-6294a90a350f2026-07-21Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRAvKAREc2b21ad5-fa83-1fb6-e053-2a95a90a3d0f2026-01-14Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRBryant Ranch Prepackd3faac3a-5c8c-4987-9703-c161fb29ec562025-10-28Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRPD-Rx Pharmaceuticals, Inc.2c44b8d2-3b70-4e8b-af03-2e917178f7612025-10-20Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRMacleods Pharmaceuticals Limitedeeeee9c4-8566-4100-8ca4-3df936a3365d2025-09-17Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRBryant Ranch Prepack2c579bc7-8130-4935-a999-62b4b1c207062025-03-25Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRCamber Pharmaceuticals, Inc.08c58224-5920-4853-8c59-ec5fbb66c2f62025-01-09Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRAurobindo Pharma Limitedfcf0b0fa-bb2c-4f2c-aa9f-1f2da65d83432024-06-15Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRRising Pharma Holdings, Inc.d5c46506-a350-44a1-9440-d939da895f162024-06-15Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRProficient Rx LPb75abffb-0a90-4abd-8ed8-81be1d8fe3642023-01-01Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRTeva Pharmaceuticals USA, Inc.3f02042f-8f51-4ccf-b608-5dcd75d100fb2022-11-28Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR
FamciclovirFAMCICLOVIRProficient Rx LP29b7ea8b-b976-45cb-9006-a27ba797b0fd2022-06-01Warnings, Adverse reactionsName fallback
generic name: FAMCICLOVIR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.