FDA.reportPublic FDA data

Famciclovir

Product NDC
17856-0706
11-digit product format
178560706
Labeler code
17856
Product ID
17856-0706_b2225461-d7b7-45ef-a1a5-b3da71890e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA202438
Marketing category
ANDA
Marketing start
2014-09-10
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1005b6ff-d0c1-48ab-8c99-f6ab62104661Product name220250401
39b4c6c3-4107-094f-96fa-0d1c48033493Product name220150326

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0706-12023-01-30C16284748780-1f386c649-b2f0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0706-1Famciclovir30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0706FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 1 package rows20210406_2337e2f6-039b-4f5c-bca4-b0771c4cb632.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199192famciclovir 125 MG Oral TabletPSN2337e2f6-039b-4f5c-bca4-b0771c4cb6321
199193famciclovir 250 MG Oral TabletPSN2337e2f6-039b-4f5c-bca4-b0771c4cb6321
198382famciclovir 500 MG Oral TabletPSN2337e2f6-039b-4f5c-bca4-b0771c4cb6321
199192famciclovir 125 MG Oral TabletSCD2337e2f6-039b-4f5c-bca4-b0771c4cb6321
199193famciclovir 250 MG Oral TabletSCD2337e2f6-039b-4f5c-bca4-b0771c4cb6321
198382famciclovir 500 MG Oral TabletSCD2337e2f6-039b-4f5c-bca4-b0771c4cb6321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0706-11785607060130 TABLET, FILM COATED in 1 BOTTLE (17856-0706-1) 2014-09-100000-00-00NoNoCurrent