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NDC 52015-0700-22 DIFICID 200 mg/5mL Details
DIFICID 200 mg/5mL
DIFICID is a ORAL GRANULE, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is FIDAXOMICIN.
MedlinePlus Drug Summary
Fidaxomicin is used to treat diarrhea caused by Clostridium difficile (C. difficile; a type of bacteria that may cause severe or life-threatening diarrhea) in adults and children 6 months of age and older. Fidaxomicin is in a class of medications called macrolide antibiotics. It works by killing bacteria in the intestines. Fidaxomicin will not treat infections in any other part of the body. Antibiotics such as fidaxomicin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 52015-0700-22Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fidaxomicin
Product Information
| NDC | 52015-0700 |
|---|---|
| Product ID | 52015-700_196bc622-60fc-4d2a-8d8f-93aa8d0db246 |
| Associated GPIs | 03530025001920 |
| GCN Sequence Number | 080794 |
| GCN Sequence Number Description | fidaxomicin SUSP RECON 40 MG/ML ORAL |
| HIC3 | W1D |
| HIC3 Description | MACROLIDE ANTIBIOTICS |
| GCN | 47769 |
| HICL Sequence Number | 037674 |
| HICL Sequence Number Description | FIDAXOMICIN |
| Brand/Generic | Brand |
| Proprietary Name | DIFICID |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | FIDAXOMICIN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GRANULE, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/5mL |
| Substance Name | FIDAXOMICIN |
| Labeler Name | Merck Sharp & Dohme LLC |
| Pharmaceutical Class | Macrolide Antibacterial [EPC], Macrolides [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213138 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52015-0700-22 (52015070022)
| NDC Package Code | 52015-700-22 |
|---|---|
| Billing NDC | 52015070022 |
| Package | 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 |
| Pricing Information | N/A |