Prescription drug · NDA
Cefepime NDC 0338-1301
Cefepime hydrochloride 1 g/50mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-1301-41 | 0033813014100338130141 | 24 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAGMarketed from Aug 5, 2008 | |
| 0338-1301-48 | 0033813014800338130148 | 12 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAGMarketed from Aug 5, 2008 |
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)
- Cefepime
- Generic name (nonproprietary)
- cefepime
- Active ingredients
- Cefepime hydrochloride — 1 g/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050817
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0338-1301_535caad0-ae02-4ceb-b4d1-192222633719SPL ID 535caad0-ae02-4ceb-b4d1-192222633719SPL set ID be5f8ca6-7232-423a-a2d5-cccb7abe7921RxCUI 1665088, 1665093UNII I8X1O0607P
- 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
N400338130141followed by a unit qualifier and the quantityPackage 00338-1301-41. 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)
Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia ( 1.1 ); empiric therapy for febrile neutropenic patients ( 1.2 ); uncomplicated and complicated urinary tract infections ( 1.3 ); uncomplicated skin and skin structure infections ( 1.4 ); and complicated intra-abdominal infections (used in combination with metronidazole) ( 1.5 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly s…
Excerpt only. Read the full label for complete information.
About NDC 0338-1301
- What is NDC 0338-1301?
- 0338-1301 is the product NDC for Cefepime, Cefepime hydrochloride 1 g/50mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefepime.
- What is the active ingredient?
- Cefepime hydrochloride.
- 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 Cefepime?
- 20 other product NDCs are listed under this name. See all Cefepime NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefepime products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6245 | 60505-6245-04 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Apotex Corp. | 60505-6246 | 60505-6246-04 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-130 | 44567-0130-10 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-131 | 44567-0131-10 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Hospira, Inc. | 0409-9566 | 00409-9566-10 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Hospira, Inc. | 0409-9735 | 00409-9735-10 |
| Cefepime | Cefepime hydrochloride 100 g/1 | Injection, Powder, For solutionIntravenous | SAMSON MEDICAL TECHNOLOGIES LLC | 66288-8100 | 66288-8100-01 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6144 | 60505-6144-04 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Apotex Corp. | 60505-6145 | 60505-6145-04 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6146 | 60505-6146-0060505-6146-04 |