Fidaxomicin
- Product NDC
- 0480-2596
- 11-digit product format
- 004802596
- Labeler code
- 0480
- Product ID
- 0480-2596_62052410-0ab9-4ed6-aff5-36ef8eb81850
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fidaxomicin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA208443
- Marketing category
- ANDA
- Marketing start
- 2025-07-15
- Substance
- FIDAXOMICIN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Macrolide Antibacterial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fidaxomicin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FIDAXOMICIN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z5N076G8YQ |
| Rxcui | 1111106 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-2596-34 | Fidaxomicin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-2596-34 | 00480259634 | 20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34) | 2025-07-15 | No | No | Historical |