Fidaxomicin
- Product NDC
- 60505-4833
- 11-digit product format
- 605054833
- Labeler code
- 60505
- Product ID
- 60505-4833_a9a2681d-631b-f559-de45-a06b3723e65c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fidaxomicin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA219559
- Marketing category
- ANDA
- Marketing start
- 2026-02-03
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fidaxomicin
- Listing expiration
- 2027-12-31
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 |
|---|
| 60505-4833-2 | Fidaxomicin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 60505-4833-2 | Fidaxomicin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-4833-2 | 60505483302 | 1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2026-02-03 | No | No | Historical |