NDC 52015-700
DIFICID
Fidaxomicin
DIFICID is a Oral Granule, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Fidaxomicin.
| Product ID | 52015-700_14fbf752-8720-435a-b9ad-073c43db521a |
| NDC | 52015-700 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DIFICID |
| Generic Name | Fidaxomicin |
| Dosage Form | Granule, For Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-02-18 |
| Marketing Category | NDA / NDA |
| Application Number | NDA213138 |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | FIDAXOMICIN |
| Active Ingredient Strength | 200 mg/5mL |
| Pharm Classes | Macrolides [CS],Macrolide Antibacterial [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 52015-700-22
1 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)
| Marketing Start Date | 2020-02-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 52015-700-23 [52015070023]
DIFICID GRANULE, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA213138 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-02-18 |
NDC 52015-700-22 [52015070022]
DIFICID GRANULE, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA213138 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-02-18 |
NDC 52015-700-21 [52015070021]
DIFICID GRANULE, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA213138 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-02-18 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FIDAXOMICIN | 200 mg/5mL |
OpenFDA Data
| SPL SET ID: | dd966338-c820-4270-b704-09ef75fa3ceb |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Macrolides [CS]
- Macrolide Antibacterial [EPC]
NDC Crossover Matching brand name "DIFICID" or generic name "Fidaxomicin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52015-080 | Dificid | fidaxomicin |
| 52015-700 | DIFICID | FIDAXOMICIN |
Trademark Results [DIFICID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIFICID 77523422 4035329 Live/Registered |
MERCK SHARP & DOHME CORP. 2008-07-16 |
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