Fidaxomicin
- Product NDC
- 0054-0795
- 11-digit product format
- 000540795
- Labeler code
- 0054
- Product ID
- 0054-0795_77be719d-9937-40ab-a73a-b0db15398280
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fidaxomicin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Hikma Pharmceuticals USA Inc.
- Application
- ANDA219737
- Marketing category
- ANDA
- Marketing start
- 2026-10-07
- Substance
- FIDAXOMICIN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Macrolide Antibacterial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0054-0795-07 | 00054079507 | 20 TABLET, COATED in 1 BOTTLE (0054-0795-07) | 2026-10-07 | No | No | Historical |