Prescription drug · ANDA
Ceftriaxone Sodium NDC 76420-596
Ceftriaxone sodium 500 mg/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-596-01 | 76420059601 | 1 VIAL, SINGLE-USE in 1 CARTON (76420-596-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from Sep 2, 2023 | |
| 76420-596-10 | 76420059610 | 10 VIAL, SINGLE-USE in 1 CARTON (76420-596-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from Sep 2, 2023 |
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)
- Ceftriaxone Sodium
- Generic name (nonproprietary)
- ceftriaxone sodium
- Active ingredients
- Ceftriaxone sodium — 500 mg/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203702
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 76420-596_045b6441-f12b-f2b4-e063-6394a90ad0acSPL ID 045b6441-f12b-f2b4-e063-6394a90ad0acSPL set ID f01cf0e5-caaf-4759-ba21-50f3aceff523RxCUI 1665005UNII 023Z5BR09K
- 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 codeMed-Code curated
J0696 — Injection, ceftriaxone sodium, per 250 mg
Billing unit: 250 mg. Units on the claim = dose given ÷ 250 mg.
- 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
N476420059601followed by a unit qualifier and the quantityPackage 76420-0596-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Before instituting treatment with Ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for injection, USP and other antibacterial drugs, Ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203702
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 |
|---|---|---|---|---|
| Ceftriaxone Sodium | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-1007 |
| Ceftriaxone Sodium | Ceftriaxone sodium 250 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-1005 |
| Ceftriaxone Sodium | Ceftriaxone sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-1006 |
| Ceftriaxone Sodium | Ceftriaxone sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-1008 |
| Ceftriaxone Sodium | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Sportpharm LLC | 85766-069 |
| Ceftriaxone Sodium | Ceftriaxone sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Sportpharm LLC | 85766-128 |
| Ceftriaxone Sodium | Ceftriaxone sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | A-S Medication Solutions | 50090-3838 |
| Ceftriaxone Sodium | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Proficient Rx LP | 71205-545 |
| Ceftriaxone Sodium | Ceftriaxone sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Proficient Rx LP | 82804-066 |
| Ceftriaxone Sodium | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6148 |
| Ceftriaxone Sodium | Ceftriaxone sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6149 |
| Ceftriaxone Sodium | Ceftriaxone sodium 250 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6151 |
| Ceftriaxone Sodium | Ceftriaxone sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6152 |