Prescription drug · ANDA
Cefepime NDC 66288-8100
Cefepime hydrochloride 100 g/1 · Injection, Powder, For solution · Intravenous · SAMSON MEDICAL TECHNOLOGIES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66288-8100-1 | 6628881000166288810001 | 1 BAG in 1 BAG (66288-8100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAGMarketed from Oct 1, 2018 |
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
- Active ingredients
- Cefepime hydrochloride — 100 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- SAMSON MEDICAL TECHNOLOGIES LLCNDC labeler code 66288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209408
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 66288-8100_c3258e86-4c07-4656-9767-ca959ecee86dSPL ID c3258e86-4c07-4656-9767-ca959ecee86dSPL set ID f776421b-bd46-4664-b9ff-533d805e1277RxCUI 2058953UNII 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
N466288810001followed by a unit qualifier and the quantityPackage 66288-8100-01. 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, USP 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 and other antibacterial drugs, cefepime should be used only to treat infections that are proven or…
Excerpt only. Read the full label for complete information.
About NDC 66288-8100
- What is NDC 66288-8100?
- 66288-8100 is the product NDC for Cefepime, Cefepime hydrochloride 100 g/1 injection, powder, for solution, listed with the FDA by SAMSON MEDICAL TECHNOLOGIES LLC. It has 1 package NDC, 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?
- SAMSON MEDICAL TECHNOLOGIES LLC, NDC labeler code 66288. 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 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 |
| Cefepime | Cefepime hydrochloride 2 g/1 | Injection, Powder, For solutionIntravenous | Apotex Corp. | 60505-6147 | 60505-6147-0060505-6147-04 |