Prescription drug · NDA
Zerbaxa (Ceftolozane and tazobactam) NDC 67919-030
Ceftolozane sulfate 1 g/10mL; Tazobactam sodium .5 g/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67919-030-01 | 67919003001 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 19, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zerbaxa
- Generic name (nonproprietary)
- ceftolozane and tazobactam
- Active ingredients
- Ceftolozane sulfate — 1 g/10mLTazobactam sodium — .5 g/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 67919
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206829
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 67919-030_23d9b7be-abf3-4ca6-bce8-d80643a708e7SPL ID 23d9b7be-abf3-4ca6-bce8-d80643a708e7SPL set ID 70ac1d90-eff3-4f0b-9f46-5846c571b32fRxCUI 1597615, 1597620UNII 7R247U84HY, UXA545ABTT
- Pharmacologic class
- Cephalosporin Antibacterial; beta Lactamase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467919003001followed by a unit qualifier and the quantityPackage 67919-0030-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole. ( 1.1 ) Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis. ( 1.2 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP). ( 1.3 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bact…
Excerpt only. Read the full label for complete information.
About NDC 67919-030
- What is NDC 67919-030?
- 67919-030 is the product NDC for Zerbaxa, Ceftolozane sulfate 1 g/10mL; Tazobactam sodium .5 g/10mL injection, powder, lyophilized, for solution, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zerbaxa (Ceftolozane and tazobactam).
- What is the active ingredient?
- Ceftolozane sulfate, Tazobactam sodium.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 67919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zerbaxa?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.