FDA.reportPublic FDA data

DIFICID

Product NDC
52015-700
11-digit product format
520150700
Labeler code
52015
Product ID
52015-700_21c95e9f-0a3d-4fb8-90b5-934bad817d00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FIDAXOMICIN
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA213138
Marketing category
NDA
Marketing start
2020-02-18
Substance
FIDAXOMICIN
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antibacterial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DIFICID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FIDAXOMICIN200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ5N076G8YQ
Rxcui1111106, 1111110, 2279843, 2279847

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e4a3aa8-f104-4f9a-4201-4cd94e142139Product name220200612

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52015-700-21DIFICID150 mL in 1 BOTTLE, GLASSGRANULE, FOR SUSPENSION15021
52015-700-22DIFICID1 in 1 CARTONGRANULE, FOR SUSPENSION121
52015-700-23DIFICID1 in 1 POUCHGRANULE, FOR SUSPENSION121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FIDAXOMICINACTIVE INGREDIENTZ5N076G8YQDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
FIDAXOMICINACTIVE MOIETYZ5N076G8YQDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52015-700DIFICID (FIDAXOMICIN) TABLET, FILM COATED DIFICID (FIDAXOMICIN) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC]20Current NDC, Legacy NDC, 3 package rows20241030_dd966338-c820-4270-b704-09ef75fa3ceb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111110DIFICID 200 MG Oral TabletPSNdd966338-c820-4270-b704-09ef75fa3ceb21
2279847Dificid 40 MG/mL Oral SuspensionPSNdd966338-c820-4270-b704-09ef75fa3ceb21
1111106fidaxomicin 200 MG Oral TabletPSNdd966338-c820-4270-b704-09ef75fa3ceb21
2279843fidaxomicin 40 MG/mL Oral SuspensionPSNdd966338-c820-4270-b704-09ef75fa3ceb21
1111110fidaxomicin 200 MG Oral Tablet [Dificid]SBDdd966338-c820-4270-b704-09ef75fa3ceb21
2279847fidaxomicin 40 MG/ML Oral Suspension [Dificid]SBDdd966338-c820-4270-b704-09ef75fa3ceb21
1111106fidaxomicin 200 MG Oral TabletSCDdd966338-c820-4270-b704-09ef75fa3ceb21
2279843fidaxomicin 40 MG/ML Oral SuspensionSCDdd966338-c820-4270-b704-09ef75fa3ceb21
1111110Dificid 200 MG Oral TabletSYdd966338-c820-4270-b704-09ef75fa3ceb21
2279847Dificid 40 MG/ML Oral SuspensionSYdd966338-c820-4270-b704-09ef75fa3ceb21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52015-700-2152015070021150 mL in 1 BOTTLE, GLASS150 mlHistorical
52015-700-22520150700221 POUCH in 1 CARTON (52015-700-22) / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21) 1 pouch2020-02-180000-00-00NoNoCurrent
52015-700-23520150700231 in 1 POUCHHistorical