Famciclovir

Product NDC
33342-024
11-digit product format
333420024
Labeler code
33342
Product ID
33342-024_b783e311-5fb2-4ab3-b10a-36c87c2a7d5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA201022
Marketing category
ANDA
Marketing start
2012-01-13
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
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
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
33342-024-07Famciclovir30 in 1 BOTTLETABLET, FILM COATED3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-024-07EA - Each33342-024e23dcd61-677b-498b-875e-3e840b3fec1b12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-024FAMCICLOVIR TABLET, FILM COATED FAMCICLOVIR (FAMCICLOVIR ) TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]13Current NDC, Legacy NDC, 1 package rows20250122_eeeee9c4-8566-4100-8ca4-3df936a3365d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199192famciclovir 125 MG Oral TabletPSNeeeee9c4-8566-4100-8ca4-3df936a3365d14
199193famciclovir 250 MG Oral TabletPSNeeeee9c4-8566-4100-8ca4-3df936a3365d14
198382famciclovir 500 MG Oral TabletPSNeeeee9c4-8566-4100-8ca4-3df936a3365d14
199192famciclovir 125 MG Oral TabletSCDeeeee9c4-8566-4100-8ca4-3df936a3365d14
199193famciclovir 250 MG Oral TabletSCDeeeee9c4-8566-4100-8ca4-3df936a3365d14
198382famciclovir 500 MG Oral TabletSCDeeeee9c4-8566-4100-8ca4-3df936a3365d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-024-073334200240730 TABLET, FILM COATED in 1 BOTTLE (33342-024-07) 2012-01-130000-00-00NoNoCurrent