Famciclovir

Product NDC
42291-414
11-digit product format
422910414
Labeler code
42291
Product ID
42291-414_485cfe40-2ff0-e83f-e063-6394a90a221c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA077487
Marketing category
ANDA
Marketing start
2021-05-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famciclovir
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMCICLOVIR125 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
42291-414-30Famciclovir30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-414FAMCICLOVIR TABLET, FILM COATED [AVKARE]3Current NDC, Legacy NDC, 1 package rows20240110_c2b21ad5-fa83-1fb6-e053-2a95a90a3d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199192famciclovir 125 MG Oral TabletPSNc2b21ad5-fa83-1fb6-e053-2a95a90a3d0f4
199193famciclovir 250 MG Oral TabletPSNc2b21ad5-fa83-1fb6-e053-2a95a90a3d0f4
198382famciclovir 500 MG Oral TabletPSNc2b21ad5-fa83-1fb6-e053-2a95a90a3d0f4
199192famciclovir 125 MG Oral TabletSCDc2b21ad5-fa83-1fb6-e053-2a95a90a3d0f4
199193famciclovir 250 MG Oral TabletSCDc2b21ad5-fa83-1fb6-e053-2a95a90a3d0f4
198382famciclovir 500 MG Oral TabletSCDc2b21ad5-fa83-1fb6-e053-2a95a90a3d0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-414-304229104143030 TABLET, FILM COATED in 1 BOTTLE (42291-414-30) 2021-05-190000-00-00NoNoCurrent