Ceftaroline Fosamil
- Product NDC
- 60505-6124
- 11-digit product format
- 605056124
- Labeler code
- 60505
- Product ID
- 60505-6124_009f5e49-4075-974b-1178-42875743658a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ceftaroline Fosamil
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Apotex Corp.
- Application
- ANDA208075
- Marketing category
- ANDA
- Marketing start
- 2026-02-12
- Substance
- CEFTAROLINE FOSAMIL
- Active strength
- 400 mg/20mL
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ceftaroline Fosamil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEFTAROLINE FOSAMIL | 400 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7P6FQA5D21 |
| Rxcui | 1040008, 1040014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-6124-0 | Ceftaroline Fosamil | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 6 |
| 60505-6124-1 | Ceftaroline Fosamil | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-6124-0 | 60505612400 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | Historical |
| 60505-6124-1 | 60505612401 | 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6124-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6124-0) | | 2026-02-12 | No | No | Historical |