FDA.reportPublic FDA data

Famciclovir

Product NDC
63629-7890
11-digit product format
636297890
Labeler code
63629
Product ID
63629-7890_65eceb53-43c8-44c5-95f0-62304e8d75c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202438
Marketing category
ANDA
Marketing start
2014-09-10
Substance
FAMCICLOVIR
Active strength
500 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famciclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMCICLOVIR500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQIC03ANI02
Rxcui198382

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7890-12025-03-25C16284748780-11030e365-39f9-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994
63629-7890-12024-01-30C16284748780-11030e365-39f9-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7890-1Famciclovir30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7890FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 1 package rows20250327_2c579bc7-8130-4935-a999-62b4b1c20706.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198382famciclovir 500 MG Oral TabletPSN2c579bc7-8130-4935-a999-62b4b1c207063
198382famciclovir 500 MG Oral TabletSCD2c579bc7-8130-4935-a999-62b4b1c207063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7890-16362978900130 TABLET, FILM COATED in 1 BOTTLE (63629-7890-1) 2019-01-110000-00-00NoNoCurrent