Famciclovir

Product NDC
64980-351
11-digit product format
649800351
Labeler code
64980
Product ID
64980-351_edd6ee53-72b7-48e5-aef4-30c077db7545
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA091114
Marketing category
ANDA
Marketing start
2011-03-21
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, 199192, 199193

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
64980-351-03Famciclovir30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-351-03EA - Each64980-351fbfb467e-3d48-4ef9-ac4d-c6e1572df1f712021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-351FAMCICLOVIR TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 1 package rows20240619_d5c46506-a350-44a1-9440-d939da895f16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199192famciclovir 125 MG Oral TabletPSNd5c46506-a350-44a1-9440-d939da895f164
199193famciclovir 250 MG Oral TabletPSNd5c46506-a350-44a1-9440-d939da895f164
198382famciclovir 500 MG Oral TabletPSNd5c46506-a350-44a1-9440-d939da895f164
199192famciclovir 125 MG Oral TabletSCDd5c46506-a350-44a1-9440-d939da895f164
199193famciclovir 250 MG Oral TabletSCDd5c46506-a350-44a1-9440-d939da895f164
198382famciclovir 500 MG Oral TabletSCDd5c46506-a350-44a1-9440-d939da895f164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-351-036498003510330 TABLET, FILM COATED in 1 BOTTLE (64980-351-03) 2011-03-210000-00-00NoNoCurrent