ZEVTERA
- Product NDC
- 68547-578
- 11-digit product format
- 685470578
- Labeler code
- 68547
- Product ID
- 68547-578_b1d1d7ef-5f90-4e2e-b4cf-494815d8647c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ceftobiprole medocaril sodium
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- La Jolla Pharmaceutical Company
- Application
- NDA218275
- Marketing category
- NDA
- Marketing start
- 2025-04-01
- Substance
- CEFTOBIPROLE MEDOCARIL SODIUM
- Active strength
- 667 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZEVTERA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEFTOBIPROLE MEDOCARIL SODIUM | 667 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N99027V28J |
| Rxcui | 2703561, 2703567 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68547-578-01 | ZEVTERA | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | | 4 |
| 68547-578-10 | ZEVTERA | 10 in 1 BOX | INJECTION, POWDER, FOR SOLUTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68547-578 | ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) INJECTION, POWDER, FOR SOLUTION [LA JOLLA PHARMACEUTICAL COMPANY] | 3 | Current NDC, 2 package rows | 20250416_2bd685df-7dc6-78a6-e063-6294a90a580b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68547-578-01 | 68547057801 | 1 in 1 VIAL, GLASS | | | | Historical |
| 68547-578-10 | 68547057810 | 10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01) | 2025-04-01 | No | No | Current |