FDA.reportPublic FDA data

FAMCICLOVIR

Product NDC
60505-3245
11-digit product format
605053245
Labeler code
60505
Product ID
60505-3245_e3d7739d-57fe-7036-bb4e-065f64e48912
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMCICLOVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA091480
Marketing category
ANDA
Marketing start
2011-12-20
Marketing end
0000-00-00
Substance
FAMCICLOVIR
Active strength
125 mg/1
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
60505-3245-3FAMCICLOVIR30 in 1 BOTTLETABLET, FILM COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3245-3EA - Each60505-32455b9d6b73-7c18-4b15-ad97-dec984f653e212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMCICLOVIRACTIVE INGREDIENTQIC03ANI02FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]8
penciclovirACTIVE MOIETY359HUE8FJCFAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]8
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3245FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]18Legacy NDC, 1 package rows20240423_a5c46194-3692-cd26-0d85-6371974ccc44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199192famciclovir 125 MG Oral TabletPSNa5c46194-3692-cd26-0d85-6371974ccc4418
199193famciclovir 250 MG Oral TabletPSNa5c46194-3692-cd26-0d85-6371974ccc4418
198382famciclovir 500 MG Oral TabletPSNa5c46194-3692-cd26-0d85-6371974ccc4418
199192famciclovir 125 MG Oral TabletSCDa5c46194-3692-cd26-0d85-6371974ccc4418
199193famciclovir 250 MG Oral TabletSCDa5c46194-3692-cd26-0d85-6371974ccc4418
198382famciclovir 500 MG Oral TabletSCDa5c46194-3692-cd26-0d85-6371974ccc4418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3245-36050532450330 TABLET, FILM COATED in 1 BOTTLE (60505-3245-3) 2011-12-200000-00-00NoNoCurrent