Prescription drug · ANDA
Cefazolin NDC 0404-9835
Cefazolin sodium 225 mg/mL · Injection, Powder, For solution · Intramuscular, Intravenous · Henry Schein Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9835-99 | 00404983599 | 1 VIAL in 1 BAG (0404-9835-99) / 2.2 mL in 1 VIALMarketed from Jan 9, 2022 |
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)
- Cefazolin
- Generic name (nonproprietary)
- cefazolin
- Active ingredients
- Cefazolin sodium — 225 mg/mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Henry Schein Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065047
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0404-9835_a5e569a1-da41-44da-a31a-3c9d2c0b61c2SPL ID a5e569a1-da41-44da-a31a-3c9d2c0b61c2SPL set ID 922fb1a1-ad4c-4a12-8d5d-00fe13af18e8RxCUI 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.
- NDC on a medical claim
N400404983599followed by a unit qualifier and the quantityPackage 00404-9835-99. 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)
INDICATIONS AND USAGE Cefazolin for Injection, USP is indicated in 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 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 preventio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065047
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 225 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9923 |
| Cefazolin | Cefazolin sodium 330 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9924 |
| Cefazolin | Cefazolin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Civica, Inc. | 72572-055 |
| Cefazolin | Cefazolin sodium 330 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9262 |
| Cefazolin | Cefazolin sodium 330 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9834 |
| Cefazolin | Cefazolin sodium 330 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7027 |
| Cefazolin | Cefazolin sodium 330 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | A-S Medication Solutions | 50090-4256 |