Prescription drug · ANDA
Cefuroxime NDC 0143-9568
Cefuroxime sodium 750 mg/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9568-25 | 00143956825 | 25 VIAL in 1 CARTON (0143-9568-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9568-01)Marketed from Jan 9, 2004 |
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)
- Cefuroxime
- Generic name (nonproprietary)
- cefuroxime
- Active ingredients
- Cefuroxime sodium — 750 mg/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065048
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0143-9568_e43d5edd-fd78-43d3-b8d2-4b22b7541042SPL ID e43d5edd-fd78-43d3-b8d2-4b22b7541042SPL set ID 19902965-d2d6-433f-982d-0095014df4e8RxCUI 1665444, 1665449UNII R8A7M9MY61
- 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
N400143956825followed by a unit qualifier and the quantityPackage 00143-9568-25. 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)
INDICATIONS AND USAGE Cefuroxime for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae , Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Streptococcus pyogenes , and Escherichia coli . Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Strept…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065048
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 |
|---|---|---|---|---|
| Cefuroxime | Cefuroxime sodium 1.5 g/1 | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9567 |
| Cefuroxime | Cefuroxime sodium 1.5 g/1 | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9977 |
| Cefuroxime | Cefuroxime sodium 750 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9979 |