NDC codes

FDA NDC Directory
Product NDC (as listed)0338-9632Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-9632Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0338-9632-240033896322424 BAG in 1 CARTON (0338-9632-24) / 50 mL in 1 BAG (0338-9632-01)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 — 2 g/50mLTazobactam sodium — .25 g/50mL
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 0338-9632_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.

How CPT relates to drug billing

NDC on a medical claim

N400338963224 followed by a unit qualifier and the quantity

Package 00338-9632-24. 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.

Full label on DailyMed (opens in a new tab)

About NDC 0338-9632

What is NDC 0338-9632?
0338-9632 is the product NDC for Zosyn, Piperacillin sodium 2 g/50mL; Tazobactam sodium .25 g/50mL 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zosyn NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Zosynpiperacillin sodium and tazobactam sodiumPiperacillin sodium 3 g/50mL; Tazobactam sodium .375 g/50mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-963600338-9636-24
Zosynpiperacillin sodium and tazobactam sodiumPiperacillin sodium 4 g/100mL; Tazobactam sodium .5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-963800338-9638-12

Other NDCs under NDA 050750

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 050750
ProductStrengthForm · routeLabelerProduct NDC
Zosynpiperacillin sodium and tazobactam sodiumPiperacillin sodium 3 g/50mL; Tazobactam sodium .375 g/50mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9636
Zosynpiperacillin sodium and tazobactam sodiumPiperacillin sodium 4 g/100mL; Tazobactam sodium .5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9638
Zosyn in Galaxy Containerstazobactam sodium and piperacillin sodiumTazobactam sodium 250 mg/50mL; Piperacillin sodium 2 g/50mLInjection, SolutionIntravenousWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0206-8860
Zosyn in Galaxy Containerstazobactam sodium and piperacillin sodiumTazobactam sodium 375 mg/50mL; Piperacillin sodium 3 g/50mLInjection, SolutionIntravenousWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0206-8861
Zosyn in Galaxy Containerstazobactam sodium and piperacillin sodiumTazobactam sodium 500 mg/100mL; Piperacillin sodium 4 g/100mLInjection, SolutionIntravenousWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0206-8862

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