NDC product
Fidaxomicin
NDC 0781-5194 · Sandoz Inc
Key facts
| Product NDC | 0781-5194 |
|---|---|
| Proprietary name | Fidaxomicin |
| Nonproprietary name | Fidaxomicin |
| Substances | FIDAXOMICIN |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Labeler | Sandoz Inc |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA220465 |
| Pharmacologic classes | Macrolide Antibacterial [EPC], Macrolides [CS] |
| Marketing start | Aug 27, 2026 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: