Prescription drug · ANDA
Levofloxacin NDC 44567-435
Levofloxacin 5 mg/mL · Injection, Solution · Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-435-24 | 4456704352444567043524 | 24 POUCH in 1 CARTON (44567-435-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAGMarketed from Apr 14, 2016 |
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)
- Levofloxacin
- Generic name (nonproprietary)
- levofloxacin
- Active ingredients
- Levofloxacin — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- WG Critical Care, LLCNDC labeler code 44567
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090343
- Marketing start
- Listing expires
- Identifiers
- Product ID 44567-435_a256adcc-5d8b-4c0e-8fe3-343e5d016d7dSPL ID a256adcc-5d8b-4c0e-8fe3-343e5d016d7d
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
N444567043524followed by a unit qualifier and the quantityPackage 44567-0435-24. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 44567-435
- What is NDC 44567-435?
- 44567-435 is the product NDC for Levofloxacin, Levofloxacin 5 mg/mL injection, solution, listed with the FDA by WG Critical Care, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levofloxacin.
- What is the active ingredient?
- Levofloxacin.
- Who is the labeler?
- WG Critical Care, LLC, NDC labeler code 44567. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levofloxacin?
- 123 other product NDCs are listed under this name. See all Levofloxacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levofloxacin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1358 | 67046-1358-03 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4568 | 70518-4568-00 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-769 | 60760-0769-10 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1078 | 67046-1078-03 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-8809 | 68788-8809-0168788-8809-0268788-8809-04+1 more |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8772 | 68788-8772-0168788-8772-0268788-8772-03+2 more |
| Levofloxacinllevofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0388 | 80425-0388-0180425-0388-02 |
| Levofloxacin | Levofloxacin 250 mg/50mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-2220 | 00409-2220-24 |
| Levofloxacin | Levofloxacin 750 mg/150mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-4444 | 00409-4444-24 |
| Levofloxacin | Levofloxacin 500 mg/100mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-3330 | 00409-3330-24 |
Other NDCs under ANDA 090343
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 |
|---|---|---|---|---|
| Levofloxacin | Levofloxacin 250 mg/50mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-2220 |
| Levofloxacin | Levofloxacin 500 mg/100mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-3330 |
| Levofloxacin | Levofloxacin 750 mg/150mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-4444 |
| Levofloxacin | Levofloxacin 5 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-132 |
| Levofloxacin | Levofloxacin 5 mg/mL | Injection, SolutionIntravenous | WG Critical Care, LLC | 44567-436 |
| Levofloxacin | Levofloxacin 5 mg/mL | Injection, SolutionIntravenous | WG Critical Care, LLC | 44567-437 |