Prescription drug · ANDA
Gentamicin (gentamicin sulfate) NDC 0404-9866
Gentamicin sulfate 40 mg/mL · Injection, Solution · Intramuscular, Intravenous · Henry Schein, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9866-20 | 00404986620 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9866-20) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 10, 2022 |
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
- Generic name (nonproprietary)
- gentamicin sulfate
- Active ingredients
- Gentamicin sulfate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Henry Schein, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062366
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 0404-9866_65ca54d7-de8c-4c5f-b47e-393f24de2af9SPL ID 65ca54d7-de8c-4c5f-b47e-393f24de2af9SPL set ID 84f6eb1c-a287-489a-8c3e-aa5954cf1992RxCUI 313996UNII 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
N400404986620followed by a unit qualifier and the quantityPackage 00404-9866-20. 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 Injection, USP and other antibacterial drugs, Gentamicin Injection, USP 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 Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the fol…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062366
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 | Gentamicin sulfate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-173 |
| Gentamicin | Gentamicin sulfate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-173 |
| Gentamicin | Gentamicin sulfate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-173 |
| Gentamicin | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1508 |
| Gentamicingentamicin sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-010 |
| Gentamicingentamicin sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-010 |
| Gentamicingentamicin sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-010 |
| Gentamicingentamicin sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7311 |