What is NDC 35369-0504?

35369-0504 is the product NDC for Piperacillin and Tazobactam, Tazobactam sodium 4.5 g/180mL; Piperacillin sodium 36 g/180mL injection, powder, lyophilized, for solution, listed with the FDA by Shandong Anxin Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Tazobactam sodium, Piperacillin sodium.

Shandong Anxin Pharmaceutical Co., Ltd., NDC labeler code 35369. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Piperacillin and Tazobactam?

59 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Piperacillin and Tazobactam NDC 35369-0504

NDC codes

FDA NDC Directory

Product NDC (as listed)35369-0504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35369-0504Add 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 NDC	11-digit (billing)	Package	Copy
35369-0504-1	3536905040135369050401	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (35369-0504-1) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Apr 14, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Piperacillin and Tazobactam
Generic name (nonproprietary): piperacillin and tazobactam
Active ingredients: Tazobactam sodium — 4.5 g/180mLPiperacillin sodium — 36 g/180mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Shandong Anxin Pharmaceutical Co., Ltd.NDC labeler code 35369
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217243
Marketing start: Apr 14, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 35369-0504_7557a940-1967-4f48-8c56-d494b793d934SPL ID 7557a940-1967-4f48-8c56-d494b793d934SPL set ID f817b9be-b12b-48ac-8e4e-57ef6812eb32RxCUI 312447UNII UXA545ABTT, M98T69Q7HPUPC 0335369050411
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

N435369050401 followed by a unit qualifier and the quantity

Package 35369-0504-01. 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 Oct 14, 2024.

Indications (excerpt from the label)

Piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35369-0504

What is NDC 35369-0504?: 35369-0504 is the product NDC for Piperacillin and Tazobactam, Tazobactam sodium 4.5 g/180mL; Piperacillin sodium 36 g/180mL injection, powder, lyophilized, for solution, listed with the FDA by Shandong Anxin Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Piperacillin and Tazobactam.
What is the active ingredient?: Tazobactam sodium, Piperacillin sodium.
Who is the labeler?: Shandong Anxin Pharmaceutical Co., Ltd., NDC labeler code 35369. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Piperacillin and Tazobactam?: 59 other product NDCs are listed under this name. See all Piperacillin and Tazobactam 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 Piperacillin and Tazobactam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
piperacillin and tazobactam	Piperacillin sodium 3 g/15mL; Tazobactam sodium .375 g/15mL	Injection, Powder, For solutionIntravenous	Civica, Inc.	72572-414	72572-0414-10
piperacillin and tazobactam	Piperacillin sodium 4 g/20mL; Tazobactam sodium .5 g/20mL	Injection, Powder, For solutionIntravenous	Civica, Inc.	72572-418	72572-0418-10
Piperacillin and Tazobactam	Piperacillin sodium 36 g/180mL; Tazobactam sodium 4.5 g/180mL	Injection, Powder, For solutionIntravenous	Avenacy, LLC	83634-112	83634-0112-99
Piperacillin and Tazobactam	Piperacillin sodium 2 g/10mL; Tazobactam sodium .25 g/10mL	Injection, Powder, For solutionIntravenous	Avenacy, LLC	83634-104	83634-0104-20
Piperacillin and Tazobactam	Piperacillin sodium 3 g/15mL; Tazobactam sodium .375 g/15mL	Injection, Powder, For solutionIntravenous	Avenacy, LLC	83634-105	83634-0105-30
Piperacillin and Tazobactam	Piperacillin sodium 4 g/20mL; Tazobactam sodium .5 g/20mL	Injection, Powder, For solutionIntravenous	Avenacy, LLC	83634-106	83634-0106-50
Piperacillin and Tazobactampiperacillin sodium and tazobactam sodium	Piperacillin sodium 36 g/250mL; Tazobactam sodium 4.5 g/250mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-473	55150-0473-01
Piperacillin and Tazobactampiperacillin sodium and tazobactam sodium	Piperacillin sodium 12 g/100mL; Tazobactam sodium 1.5 g/100mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-474	55150-0474-01
Piperacillin and Tazobactam	Tazobactam sodium 4.5 g/180mL; Piperacillin sodium 36 g/180mL	Injection, Powder, Lyophilized, For solutionIntravenous	Apotex Corp.	60505-6262	60505-6262-00
Piperacillin and Tazobactam	Piperacillin sodium 2 g/10mL; Tazobactam sodium .25 g/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	65219-434	65219-0434-20

All 60 Piperacillin and Tazobactam NDCs

Other NDCs under ANDA 217243

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

FDA NDC Directory listings under ANDA 217243
Product	Strength	Form · route	Labeler	Product NDC
Piperacillin and Tazobactam	Tazobactam sodium 4.5 g/180mL; Piperacillin sodium 36 g/180mL	Injection, Powder, Lyophilized, For solutionIntravenous	Apotex Corp.	60505-6262