Prescription drug · ANDA
Piperacillin and Tazobactam (Piperacillin sodium,tazobactam sodium) NDC 63323-309
Piperacillin sodium 2 g/10mL; Tazobactam sodium .25 g/10mL · Injection, Powder, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-309-20 | 6332303092063323030920 | 10 VIAL in 1 BOX (63323-309-20) / 10 mL in 1 VIALMarketed from Oct 13, 2009 |
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)
- Piperacillin and Tazobactam
- Generic name (nonproprietary)
- piperacillin sodium,tazobactam sodium
- Active ingredients
- Piperacillin sodium — 2 g/10mLTazobactam sodium — .25 g/10mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065523
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-309_25123257-e41e-420d-9735-74fc71840b6cSPL ID 25123257-e41e-420d-9735-74fc71840b6cSPL set ID fc4d1e35-23eb-4654-8691-ae5bfd50a48aRxCUI 1659131, 1659137, 1659149UNII M98T69Q7HP, UXA545ABTT
- 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
N463323030920followed by a unit qualifier and the quantityPackage 63323-0309-20. 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)
Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below. Piperacillin and Tazobactam for Injection is a combination penicillin-class antibacterial and β-lactamase inhibitor indicated for treatment of: Intra-abdominal infections ( 1.1 ) Skin and skin structure infections ( 1.2 ) Female pelvic infections ( 1.3 ) Community-acquired pneumonia ( 1.4 ) Nosocomial pneumonia ( 1.5 ) 1.1 Intra-abdominal Infections Appendicitis …
Excerpt only. Read the full label for complete information.
About NDC 63323-309
- What is NDC 63323-309?
- 63323-309 is the product NDC for Piperacillin and Tazobactam, Piperacillin sodium 2 g/10mL; Tazobactam sodium .25 g/10mL injection, powder, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Piperacillin and Tazobactam (Piperacillin sodium,Tazobactam sodium).
- What is the active ingredient?
- Piperacillin sodium, Tazobactam sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.
Related NDCs: other Piperacillin and Tazobactam products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Tazobactam sodium 4.5 g/180mL; Piperacillin sodium 36 g/180mL | Injection, Powder, Lyophilized, For solutionIntravenous | Shandong Anxin Pharmaceutical Co., Ltd. | 35369-0504 | 35369-0504-01 |
Other NDCs under ANDA 065523
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 |
|---|---|---|---|---|
| Piperacillin and Tazobactampiperacillin sodium,tazobactam sodium | Piperacillin sodium 2 g/1; Tazobactam sodium .25 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-801 |
| Piperacillin and Tazobactampiperacillin sodium,tazobactam sodium | Piperacillin sodium 3 g/1; Tazobactam sodium .375 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-802 |
| Piperacillin and Tazobactampiperacillin sodium,tazobactam sodium | Piperacillin sodium 4 g/1; Tazobactam sodium .5 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-803 |
| Piperacillin and Tazobactampiperacillin sodium,tazobactam sodium | Piperacillin sodium 3 g/15mL; Tazobactam sodium .375 g/15mL | Injection, Powder, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-300 |
| Piperacillin and Tazobactampiperacillin sodium,tazobactam sodium | Piperacillin sodium 4 g/20mL; Tazobactam sodium .5 g/20mL | Injection, Powder, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-320 |
| Piperacillin and Tazobactampiperacillin sodium and tazobactam sodium | Piperacillin sodium 3 g/15mL; Tazobactam sodium .375 g/15mL | Injection, Powder, For solutionIntravenous | Civica, Inc. | 72572-573 |
| Piperacillin and Tazobactampiperacillin sodium and tazobactam sodium | Piperacillin sodium 4 g/20mL; Tazobactam sodium .5 g/20mL | Injection, Powder, For solutionIntravenous | Civica, Inc. | 72572-574 |
| Piperacillin and Tazobactam | Piperacillin sodium 2 g/10mL; Tazobactam sodium .25 g/10mL | Injection, Powder, For solutionIntravenous | Avenacy, LLC | 83634-104 |
| Piperacillin and Tazobactam | Piperacillin sodium 3 g/15mL; Tazobactam sodium .375 g/15mL | Injection, Powder, For solutionIntravenous | Avenacy, LLC | 83634-105 |
| Piperacillin and Tazobactam | Piperacillin sodium 4 g/20mL; Tazobactam sodium .5 g/20mL | Injection, Powder, For solutionIntravenous | Avenacy, LLC | 83634-106 |