52015-080 : Dificid 200 mg Oral Tablet
| NDC: | 52015-080 |
| Labeler: | Optimer Pharmaceuticals, Inc. |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Dificid |
| Dosage Form: | Oral Tablet, Film Coated |
| Application #: | NDA201699 |
| Rev. Date: |
Appearance:
| Markings: | FDX;200 |
| Shapes: |
Capsule |
| Colors: |
 White |
| Size (mm): | 14 |
| Segments: * | 1 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines. | |
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.
NDC Package Codes:
- 52015-080-01: 1 BOTTLE IN 1 CARTON (52015‑080‑01) > 20 TABLET, FILM COATED IN 1 BOTTLE
- 52015-080-02: 1 BOTTLE IN 1 CARTON (52015‑080‑02) > 60 TABLET, FILM COATED IN 1 BOTTLE
- 52015-080-12: 10 BLISTER PACK IN 1 CARTON (52015‑080‑12) > 10 TABLET, FILM COATED IN 1 BLISTER PACK
Active Ingredients:
- Fidaxomicin
Dosage Strength:
- 200 mg
Inactive Ingredients:
- Cellulose, Microcrystalline
- Starch, Corn
- Hydroxypropyl Cellulose
- Butylated Hydroxytoluene
- Sodium Starch Glycolate Type a Potato
- Magnesium Stearate
- Polyvinyl Alcohol
- Titanium Dioxide
- Talc
- Polyethylene Glycols
- Lecithin, Soybean
Pharmaceutical Classes:
- Macrolide Antibacterial [EPC]
- Macrolides [CS]
Related Products:
Based on records with the same trade name.- 52015-700 Dificid 200 mg/5ml Oral Granule, for Suspension by Merck Sharp & Dohme Corp.
- 69189-0083 Dificid 200 mg Oral Tablet, Film Coated by Avera Mckennan Hospital
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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.