Prescription drug · ANDA
Gentamicin Sulfate NDC 55154-2392
Gentamicin sulfate 40 mg/mL · Injection, Solution · Intramuscular, Intravenous · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-2392-5 | 5515423920555154239205 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-2392-5) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 29, 2005 |
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)
- Gentamicin Sulfate
- Generic name (nonproprietary)
- gentamicin sulfate
- Active ingredients
- Gentamicin sulfate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062420
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 55154-2392_77f135ab-2291-487d-a9e2-50818624fa1aSPL ID 77f135ab-2291-487d-a9e2-50818624fa1aSPL set ID 5113bfad-42ca-4bb8-9343-0b08c6cd03f0RxCUI 1870650UNII 8X7386QRLVUPC 0055154239257
- 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
N455154239205followed by a unit qualifier and the quantityPackage 55154-2392-05. 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 and other antibacterial drugs, gentamicin 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 Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: …
Excerpt only. Read the full label for complete information.
About NDC 55154-2392
- What is NDC 55154-2392?
- 55154-2392 is the product NDC for Gentamicin Sulfate, Gentamicin sulfate 40 mg/mL injection, solution, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gentamicin Sulfate.
- What is the active ingredient?
- Gentamicin sulfate.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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?
- 25 other product NDCs are listed under this name. See all Gentamicin Sulfate 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 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 | Gentamicin sulfate 1 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-110 | 21922-0110-0421922-0110-05 |
| Gentamicin Sulfate | Gentamicin sulfate 3 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8592 | 68788-8592-05 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1597 | 51662-1597-03 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9865 | 00404-9865-02 |
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0683 | 00713-0683-1500713-0683-31 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7216 | 71872-7216-01 |
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | OintmentTopical | Cosette Pharmaceuticals, Inc. | 0713-0682 | 00713-0682-1500713-0682-31 |
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | OintmentTopical | Proficient Rx LP | 71205-560 | 71205-0560-15 |
| gentamicin sulfate | Gentamicin sulfate 3 mg/mL | Solution/ dropsOphthalmic | DIRECT RX | 61919-106 | 61919-0106-05 |
| Gentamicin Sulfate | Gentamicin sulfate 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-764 | 63187-0764-05 |
Other NDCs under ANDA 062420
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 | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9865 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-1207 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1597 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7216 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7337 |