FDA.reportPublic FDA data

Famciclovir

Product NDC
55289-168
11-digit product format
552890168
Labeler code
55289
Product ID
55289-168_4199c092-c45c-3922-e063-6294a90aadb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077487
Marketing category
ANDA
Marketing start
2007-09-05
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
55289-168-03Famciclovir3 in 1 BOTTLE, PLASTICTABLET, FILM COATED320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-168-03EA - Each55289-1680bf2fa49-e412-408d-97ac-4728027ba36912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMCICLOVIRACTIVE INGREDIENTQIC03ANI02FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
FAMCICLOVIRACTIVE MOIETYQIC03ANI02FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-168FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 1 package rows20240312_2c44b8d2-3b70-4e8b-af03-2e917178f761.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198382famciclovir 500 MG Oral TabletPSN2c44b8d2-3b70-4e8b-af03-2e917178f76120
198382famciclovir 500 MG Oral TabletSCD2c44b8d2-3b70-4e8b-af03-2e917178f76120

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-168-03552890168033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03) 2011-04-140000-00-00NoNoCurrent