Prescription drug · ANDA
Ceftriaxone (Ceftriaxone sodium) NDC 0338-5002
Ceftriaxone sodium 1 g/50mL · Injection, Solution · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-5002-41 | 00338500241 | 24 BAG in 1 CASE (0338-5002-41) / 50 mL in 1 BAGMarketed from Aug 23, 2005 |
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)
- Ceftriaxone
- Generic name (nonproprietary)
- ceftriaxone sodium
- Active ingredients
- Ceftriaxone sodium — 1 g/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CompanyNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065224
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0338-5002_e6debc12-1f25-437c-970e-607f4953c7f7SPL ID e6debc12-1f25-437c-970e-607f4953c7f7SPL set ID 4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1RxCUI 1665021, 1665046UNII 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
N400338500241followed by a unit qualifier and the quantityPackage 00338-5002-41. 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 Injection, 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 Injection and other antibacterial drugs, Ceftriaxone Injection 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 selecting or modifying ant…
Excerpt only. Read the full label for complete information.
About NDC 0338-5002
- What is NDC 0338-5002?
- 0338-5002 is the product NDC for Ceftriaxone (ceftriaxone sodium), Ceftriaxone sodium 1 g/50mL injection, solution, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ceftriaxone (Ceftriaxone Sodium).
- What is the active ingredient?
- Ceftriaxone sodium.
- Who is the labeler?
- Baxter Healthcare Company, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ceftriaxone?
- 17 other product NDCs are listed under this name. See all Ceftriaxone NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0696, Injection, ceftriaxone sodium, per 250 mg. See Billing references above.
Related NDCs: other Ceftriaxone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ceftriaxone | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Civica, Inc. | 72572-061 | 72572-0061-25 |
| Ceftriaxone | Ceftriaxone sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Civica, Inc. | 72572-062 | 72572-0062-25 |
| Ceftriaxone | Ceftriaxone sodium 10 g/1 | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9678 | 00143-9678-01 |
| Ceftriaxoneceftriaxone sodium | Ceftriaxone sodium 100 g/1 | Injection, Powder, For solutionIntravenous | Samson Medical Technologies, LLC | 66288-6100 | 66288-6100-01 |
| Ceftriaxone | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-346 | 63323-0346-10 |
| ceftriaxone | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-106 | 25021-0106-10 |
| ceftriaxone | Ceftriaxone sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-107 | 25021-0107-20 |
| Ceftriaxone | Ceftriaxone sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-700 | 44567-0700-25 |
| Ceftriaxone | Ceftriaxone sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-701 | 44567-0701-95 |
| Ceftriaxone | Ceftriaxone sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-702 | 44567-0702-25 |
Other NDCs under ANDA 065224
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 |
|---|---|---|---|---|
| Ceftriaxoneceftriaxone sodium | Ceftriaxone sodium 2 g/50mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-5003 |