Prescription drug · NDA
Cefazolin (Cefazolin sodium) NDC 0338-3508
Cefazolin sodium 2 g/100mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-3508-41 | 0033835084100338350841 | 12 BAG in 1 CARTON (0338-3508-41) / 100 mL in 1 BAGMarketed from Aug 7, 2015 |
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 sodium
- Active ingredients
- Cefazolin sodium — 2 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207131
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0338-3508_092b9ea3-0c78-4236-80c9-ff97d09fa14eSPL ID 092b9ea3-0c78-4236-80c9-ff97d09fa14e
- 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
N400338350841followed by a unit qualifier and the quantityPackage 00338-3508-41. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0338-3508
- What is NDC 0338-3508?
- 0338-3508 is the product NDC for Cefazolin (cefazolin sodium), Cefazolin sodium 2 g/100mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. 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?
- Baxter Healthcare Corporation, 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 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 NDA 207131
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 |
|---|---|---|---|---|
| Cefazolincefazolin sodium | Cefazolin sodium 3 g/150mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0096 |
| Cefazolincefazolin sodium | Cefazolin sodium 1 g/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-3503 |