Prescription drug · ANDA
Gentamicin Sulfate in Sodium Chloride NDC 0338-0507
gentamicin sulfate · Gentamicin sulfate 60 mg/50mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0507-41 | 00338050741 | 50 mL in 1 BAG (0338-0507-41)Marketed from Sep 7, 1982 | |
| 0338-0507-48 | 00338050748 | 100 mL in 1 BAG (0338-0507-48)Marketed from Sep 7, 1982 |
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)
- Gentamicin Sulfate in Sodium Chloride
- Generic name (nonproprietary)
- gentamicin sulfate
- Active ingredients
- Gentamicin sulfate — 60 mg/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062373
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 0338-0507_aacff3ac-5df9-4872-b074-78930c9c9b79SPL ID aacff3ac-5df9-4872-b074-78930c9c9b79SPL set ID 449c9a41-d61e-49fd-b5e3-d76f74b92acfRxCUI 197736, 242816, 310473, 310477, 1870631, 1870633UNII 8X7386QRLV
- Pharmacologic class
- Aminoglycoside 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
N400338050741followed by a unit qualifier and the quantityPackage 00338-0507-41. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062373
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 |
|---|---|---|---|---|
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 80 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0509 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 100 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0511 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 80 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0503 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 100 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0505 |