Prescription drug · ANDA
Gentamicin Sulfate in Sodium Chloride (Gentamicin sulfate) NDC 0338-0509
Gentamicin sulfate 80 mg/50mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0509-41 | 0033805094100338050941 | 50 mL in 1 BAG (0338-0509-41)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 — 80 mg/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- 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 0338-0509_9372a876-0913-4312-bf12-be6837cab74fSPL ID 9372a876-0913-4312-bf12-be6837cab74f
- 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
N400338050941followed by a unit qualifier and the quantityPackage 00338-0509-41. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0338-0509
- What is NDC 0338-0509?
- 0338-0509 is the product NDC for Gentamicin Sulfate in Sodium Chloride, Gentamicin sulfate 80 mg/50mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gentamicin Sulfate in Sodium Chloride (Gentamicin Sulfate).
- What is the active ingredient?
- Gentamicin sulfate.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gentamicin Sulfate in Sodium Chloride?
- 4 other product NDCs are listed under this name. See all Gentamicin Sulfate in Sodium Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gentamicin Sulfate in Sodium Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 80 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0503 | 00338-0503-48 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 100 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0505 | 00338-0505-48 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 60 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0507 | 00338-0507-4100338-0507-48 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 100 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0511 | 00338-0511-41 |
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/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 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 60 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0507 |
| Gentamicin Sulfate in Sodium Chloridegentamicin sulfate | Gentamicin sulfate 100 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0511 |