FDA.reportPublic FDA data

Famciclovir

Product NDC
31722-708
11-digit product format
317220708
Labeler code
31722
Product ID
31722-708_2b438049-f70c-5388-e063-6394a90af892
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
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, 199192, 199193

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
31722-708-012021-02-19C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-052021-02-19C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-102021-02-19C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-302021-02-19C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-602021-02-19C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-012021-01-29C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-052021-01-29C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-102021-01-29C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-302021-01-29C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-602021-01-29C16284748780-1ba0f9c33-1a96-a910-e053-dadaa90a0b85These 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
31722-708-01Famciclovir100 in 1 BOTTLETABLET, FILM COATED1007
31722-708-05Famciclovir500 in 1 BOTTLETABLET, FILM COATED5007
31722-708-10Famciclovir1000 in 1 BOTTLETABLET, FILM COATED10007
31722-708-30Famciclovir30 in 1 BOTTLETABLET, FILM COATED307
31722-708-60Famciclovir60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-708-30EA - Each31722-70889f13d87-1abd-40d2-b232-5a457c64a41512015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMCICLOVIRACTIVE INGREDIENTQIC03ANI02FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
PENCICLOVIRACTIVE MOIETY359HUE8FJCFAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-708FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 5 package rows20250110_08c58224-5920-4853-8c59-ec5fbb66c2f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199192famciclovir 125 MG Oral TabletPSN08c58224-5920-4853-8c59-ec5fbb66c2f67
199193famciclovir 250 MG Oral TabletPSN08c58224-5920-4853-8c59-ec5fbb66c2f67
198382famciclovir 500 MG Oral TabletPSN08c58224-5920-4853-8c59-ec5fbb66c2f67
199192famciclovir 125 MG Oral TabletSCD08c58224-5920-4853-8c59-ec5fbb66c2f67
199193famciclovir 250 MG Oral TabletSCD08c58224-5920-4853-8c59-ec5fbb66c2f67
198382famciclovir 500 MG Oral TabletSCD08c58224-5920-4853-8c59-ec5fbb66c2f67
198382famciclovir 500 MG Oral TabletPSN29b7ea8b-b976-45cb-9006-a27ba797b0fd4
198382famciclovir 500 MG Oral TabletSCD29b7ea8b-b976-45cb-9006-a27ba797b0fd4
198382famciclovir 500 MG Oral TabletPSN2c579bc7-8130-4935-a999-62b4b1c207063
198382famciclovir 500 MG Oral TabletSCD2c579bc7-8130-4935-a999-62b4b1c207063
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
31722-708-0131722070801100 TABLET, FILM COATED in 1 BOTTLE (31722-708-01) 2014-09-100000-00-00NoNoCurrent
31722-708-0531722070805500 TABLET, FILM COATED in 1 BOTTLE (31722-708-05) 2014-09-100000-00-00NoNoCurrent
31722-708-10317220708101000 TABLET, FILM COATED in 1 BOTTLE (31722-708-10) 2014-09-100000-00-00NoNoCurrent
31722-708-303172207083030 TABLET, FILM COATED in 1 BOTTLE (31722-708-30) 2014-09-100000-00-00NoNoCurrent
31722-708-603172207086060 TABLET, FILM COATED in 1 BOTTLE (31722-708-60) 2014-09-100000-00-00NoNoCurrent