FDA.reportPublic FDA data

Dificid

Product NDC
52015-080
11-digit product format
520150080
Labeler code
52015
Product ID
52015-080_21c95e9f-0a3d-4fb8-90b5-934bad817d00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fidaxomicin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA201699
Marketing category
NDA
Marketing start
2011-05-27
Substance
FIDAXOMICIN
Active strength
200 mg/1
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/1

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
52015-080-01Dificid20 in 1 BOTTLETABLET, FILM COATED2021
52015-080-01Dificid1 in 1 CARTONTABLET, FILM COATED121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52015-080DIFICID (FIDAXOMICIN) TABLET, FILM COATED DIFICID (FIDAXOMICIN) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC]20Current NDC, Legacy NDC, 2 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
52015-080-01520150080011 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-05-270000-00-00NoNoCurrent