Prescription drug · ANDA
Cefazolin (Cefazolin sodium) NDC 63323-238
Cefazolin sodium 10 g/1 · Powder, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-238-61 | 6332302386163323023861 | 10 VIAL in 1 CARTON (63323-238-61) / 1 POWDER, FOR SOLUTION in 1 VIAL (63323-238-01)Marketed from Jun 14, 2011 |
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)
- Cefazolin
- Generic name (nonproprietary)
- cefazolin sodium
- Active ingredients
- Cefazolin sodium — 10 g/1
- Dosage form
- 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 065306
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 63323-238_9684b8e0-7438-41d9-89e1-b217b5568360SPL ID 9684b8e0-7438-41d9-89e1-b217b5568360SPL set ID 47a8928f-708d-418a-829b-36eded96bac0RxCUI 313920UNII P380M0454Z
- Pharmacologic class
- Cephalosporin Antibacterial
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
N463323023861followed by a unit qualifier and the quantityPackage 63323-0238-61. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE: Cefazolin for Injection, USP is indicated for the treatment of the following serious infections due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent preven…
Excerpt only. Read the full label for complete information.
About NDC 63323-238
- What is NDC 63323-238?
- 63323-238 is the product NDC for Cefazolin (cefazolin sodium), Cefazolin sodium 10 g/1 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?
- Cefazolin (Cefazolin Sodium).
- What is the active ingredient?
- Cefazolin 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 Cefazolin?
- 42 other product NDCs are listed under this name. See all Cefazolin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefazolin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefazolin | Cefazolin sodium 2 g/1 | Injection, Powder, For solutionIntravenous | Civica, Inc. | 72572-054 | 72572-0054-25 |
| Cefazolincefazolin sodium | Cefazolin sodium 3 g/150mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0096 | 00338-0096-06 |
| Cefazolin | Cefazolin sodium 3 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-845 | 44567-0845-25 |
| Cefazolin | Cefazolin sodium 3 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6266 | 60505-6266-05 |
| Cefazolin | Cefazolin sodium 2 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-840 | 44567-0840-25 |
| Cefazolin | Cefazolin sodium 2 g/1 | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9139 | 00143-9139-25 |
| Cefazolin | Cefazolin sodium 3 g/1 | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9140 | 00143-9140-25 |
| Cefazolin | Cefazolin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6243 | 60505-6243-04 |
| Cefazolin | Cefazolin sodium 10 g/1 | Injection, Powder, For solutionIntravenous | Apotex Corp. | 60505-6244 | 60505-6244-04 |
| Cefazolin | Cefazolin sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6231 | 60505-6231-05 |
Other NDCs under ANDA 065306
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 |
|---|---|---|---|---|
| Cefazolin | Cefazolin sodium 10 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-708 |