Prescription drug · ANDA
Cefazolin NDC 0781-3450
Cefazolin sodium 500 mg/1 · Injection, Powder, For solution · Intramuscular, Intravenous, Parenteral · Sandoz Inc
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Cefazolin
- Generic name (nonproprietary)
- cefazolin
- Active ingredients
- Cefazolin sodium — 500 mg/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous, Parenteral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062831
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0781-3450_05cd44b2-275f-44f5-b4f8-22393df834a1SPL ID 05cd44b2-275f-44f5-b4f8-22393df834a1SPL set ID 18e7366a-1b3e-4010-8f4a-dd559d4f2146RxCUI 1665050, 1665052UNII 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Cefazolin for injection is indicated in the treatment of the following 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 to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection in the subsequent prevention of rheumatic …
Excerpt only. Read the full label for complete information.
About NDC 0781-3450
- What is NDC 0781-3450?
- 0781-3450 is the product NDC for Cefazolin, Cefazolin sodium 500 mg/1 injection, powder, for solution, listed with the FDA by Sandoz Inc.
- What drug is associated with this NDC?
- Cefazolin.
- What is the active ingredient?
- Cefazolin sodium.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. 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 062831
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 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous, Parenteral | Sandoz Inc | 0781-3451 |
| Cefazolin | Cefazolin sodium 10 g/1 | Injection, Powder, For solutionIntravenous, Parenteral | Sandoz Inc | 0781-3452 |