Prescription drug · ANDA
Cefepime NDC 44567-240
Cefepime hydrochloride 1 g/1 · Injection, Powder, For solution · Intramuscular, Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-240-10 | 44567024010 | 10 VIAL in 1 CARTON (44567-240-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIALMarketed from Oct 10, 2014 |
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)
- Cefepime
- Generic name (nonproprietary)
- cefepime
- Active ingredients
- Cefepime hydrochloride — 1 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- WG Critical Care, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065441
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 44567-240_d2a51dbe-bcbf-4f4c-9f38-2516649c3b2fSPL ID d2a51dbe-bcbf-4f4c-9f38-2516649c3b2fSPL set ID 5fd857e5-591f-44ca-80cf-fd903660b03cRxCUI 1665088, 1665093UNII I8X1O0607PUPC 0344567240104, 0344567241101
- 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
N444567024010followed by a unit qualifier and the quantityPackage 44567-0240-10. 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 for injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: • Pneumonia. ( 1.1 ) • Empiric therapy for febrile neutropenic patients. ( 1.2 ) • Uncomplicated and complicated urinary tract infections (including pyelonephritis). ( 1.3 ) • Uncomplicated skin and skin structure infections. ( 1.4 ) • Complicated intra-abdominal infections (used in combination with metronidazole) in adults. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime for injection and other antibacterial drugs, cefepime for injection should be used only to tr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065441
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 |
|---|---|---|---|---|
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Hospira, Inc. | 0409-9566 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Hospira, Inc. | 0409-9735 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-241 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-326 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-340 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-130 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-131 |
| cefepimecefepime hydrochloride | Cefepime hydrochloride 2 g/20mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-122 |
| cefepimecefepime hydrochloride | Cefepime hydrochloride 1 g/20mL | Injection, Powder, For solutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-121 |