Prescription drug · ANDA
Cefepime (cefepime hydrochloride) NDC 67184-1003
Cefepime hydrochloride 1 g/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67184-1003-1 | 67184100301 | 10 VIAL in 1 CARTON (67184-1003-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIALMarketed from Feb 1, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride
- Active ingredients
- Cefepime hydrochloride — 1 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203704
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 67184-1003_34afba66-733f-4403-83d1-1b67b8a6633bSPL ID 34afba66-733f-4403-83d1-1b67b8a6633bSPL set ID 80b4c811-4a71-47fb-8565-85ce9d0f782cRxCUI 1665088, 1665093, 1665097UNII 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
N467184100301followed by a unit qualifier and the quantityPackage 67184-1003-01. 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)
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 treat o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203704
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 |
|---|---|---|---|---|
| Cefepimecefepime hydrochloride | Cefepime hydrochloride 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-1002 |
| Cefepimecefepime hydrochloride | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-1004 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Apotex Corp. | 60505-6147 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6144 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Apotex Corp. | 60505-6145 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6146 |
| Cefepime | Cefepime hydrochloride 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Apotex Corp. | 60505-6245 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Apotex Corp. | 60505-6246 |