FDA.reportPublic FDA data

Famciclovir

Product NDC
63187-998
11-digit product format
631870998
Labeler code
63187
Product ID
63187-998_f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-998-21Famciclovir21 in 1 BOTTLETABLET, FILM COATED214
63187-998-30Famciclovir30 in 1 BOTTLETABLET, FILM COATED304
63187-998-60Famciclovir60 in 1 BOTTLETABLET, FILM COATED604
63187-998-90Famciclovir90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-998-21EA - Each63187-9982bc5780b-b1b3-4af6-a467-7c19066099aa12018-06-11
63187-998-30EA - Each63187-9987d358c0a-537e-43a6-9985-6b0cd5e243ff12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-998FAMCICLOVIR TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20220626_29b7ea8b-b976-45cb-9006-a27ba797b0fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198382famciclovir 500 MG Oral TabletPSN29b7ea8b-b976-45cb-9006-a27ba797b0fd4
198382famciclovir 500 MG Oral TabletSCD29b7ea8b-b976-45cb-9006-a27ba797b0fd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-998-216318709982121 TABLET, FILM COATED in 1 BOTTLE (63187-998-21) 2014-09-100000-00-00NoNoCurrent
63187-998-306318709983030 TABLET, FILM COATED in 1 BOTTLE (63187-998-30) 2014-09-100000-00-00NoNoCurrent
63187-998-606318709986060 TABLET, FILM COATED in 1 BOTTLE (63187-998-60) 2014-09-100000-00-00NoNoCurrent
63187-998-906318709989090 TABLET, FILM COATED in 1 BOTTLE (63187-998-90) 2014-09-100000-00-00NoNoCurrent