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| Ingredient | Strength |
|---|
| FIDAXOMICIN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z5N076G8YQ |
| Rxcui | 1111106, 1111110, 2279843, 2279847 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52015-080-01 | Dificid | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 21 |
| 52015-080-01 | Dificid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FIDAXOMICIN | ACTIVE INGREDIENT | Z5N076G8YQ | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| FIDAXOMICIN | ACTIVE MOIETY | Z5N076G8YQ | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIFICID (FIDAXOMICIN) TABLET, FILM COATED [CUBIST PHARMACEUTICALS U.S.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52015-080 | DIFICID (FIDAXOMICIN) TABLET, FILM COATED DIFICID (FIDAXOMICIN) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC] | 20 | Current NDC, Legacy NDC, 2 package rows | 20241030_dd966338-c820-4270-b704-09ef75fa3ceb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52015-080-01 | 52015008001 | 1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2011-05-27 | 0000-00-00 | No | No | Current |