Prescription drug · NDA
Zosyn NDC 0338-9638
piperacillin sodium and tazobactam sodium · Piperacillin sodium 4 g/100mL; Tazobactam sodium .5 g/100mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-9638-12 | 00338963812 | 12 BAG in 1 CARTON (0338-9638-12) / 100 mL in 1 BAG (0338-9638-01)Marketed from Apr 1, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Zosyn
- Generic name (nonproprietary)
- piperacillin sodium and tazobactam sodium
- Active ingredients
- Piperacillin sodium — 4 g/100mLTazobactam sodium — .5 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050750
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 0338-9638_d44ebbea-a212-4060-a50b-e7fab8e70ff6SPL ID d44ebbea-a212-4060-a50b-e7fab8e70ff6SPL set ID 8db6bd91-2106-4bfd-8cc8-38aaf1e18d17RxCUI 1659131, 1659134, 1659137, 1659139, 1659149, 1659151UNII UXA545ABTT, M98T69Q7HP
- Pharmacologic class
- Penicillin-class 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
N400338963812followed by a unit qualifier and the quantityPackage 00338-9638-12. 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)
ZOSYN is a combination of piperacillin, a penicillin‑class antibacterial and tazobactam, a beta‑lactamase inhibitor, indicated for the treatment of: • Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1 ) • Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2 ) • Skin and skin structure infections in adults ( 1.3 ) • Female pelvic infections in adults ( 1.4 ) • Community-acquired pneumonia in adults ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN and other antibacterial drugs, ZOSYN should be used only to treat or prevent infections that are proven or strongly suspected…
Excerpt only. Read the full label for complete information.
About NDC 0338-9638
- What is NDC 0338-9638?
- 0338-9638 is the product NDC for Zosyn, Piperacillin sodium 4 g/100mL; Tazobactam sodium .5 g/100mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zosyn (Piperacillin sodium and tazobactam sodium).
- What is the active ingredient?
- Piperacillin sodium, Tazobactam sodium.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zosyn?
- 2 other product NDCs are listed under this name. See all Zosyn NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zosyn products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zosynpiperacillin sodium and tazobactam sodium | Piperacillin sodium 2 g/50mL; Tazobactam sodium .25 g/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-9632 | 00338-9632-24 |
| Zosynpiperacillin sodium and tazobactam sodium | Piperacillin sodium 3 g/50mL; Tazobactam sodium .375 g/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-9636 | 00338-9636-24 |
Other NDCs under NDA 050750
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zosynpiperacillin sodium and tazobactam sodium | Piperacillin sodium 2 g/50mL; Tazobactam sodium .25 g/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-9632 |
| Zosynpiperacillin sodium and tazobactam sodium | Piperacillin sodium 3 g/50mL; Tazobactam sodium .375 g/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-9636 |
| Zosyn in Galaxy Containerstazobactam sodium and piperacillin sodium | Tazobactam sodium 250 mg/50mL; Piperacillin sodium 2 g/50mL | Injection, SolutionIntravenous | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0206-8860 |
| Zosyn in Galaxy Containerstazobactam sodium and piperacillin sodium | Tazobactam sodium 375 mg/50mL; Piperacillin sodium 3 g/50mL | Injection, SolutionIntravenous | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0206-8861 |
| Zosyn in Galaxy Containerstazobactam sodium and piperacillin sodium | Tazobactam sodium 500 mg/100mL; Piperacillin sodium 4 g/100mL | Injection, SolutionIntravenous | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0206-8862 |