Prescription drug · ANDA
Gentamicin NDC 70518-4757
Gentamicin sulfate 40 mg/mL · Injection, Solution · Intramuscular, Intravenous · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4757-0 | 7051847570070518475700 | 25 VIAL, MULTI-DOSE in 1 CARTON (70518-4757-0) / 2 mL in 1 VIAL, MULTI-DOSE (70518-4757-1)Marketed from Sep 17, 2026 |
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
- Generic name (nonproprietary)
- gentamicin
- Active ingredients
- Gentamicin sulfate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215237
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 70518-4757_5bfe7519-4b6c-1897-e063-6294a90a4e1fSPL ID 5bfe7519-4b6c-1897-e063-6294a90a4e1f
- 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
N470518475700followed by a unit qualifier and the quantityPackage 70518-4757-00. 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 70518-4757
- What is NDC 70518-4757?
- 70518-4757 is the product NDC for Gentamicin, Gentamicin sulfate 40 mg/mL injection, solution, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gentamicin.
- What is the active ingredient?
- Gentamicin sulfate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 10 other product NDCs are listed under this name. See all Gentamicin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gentamicin 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 | Gentamicin sulfate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Eugia US LLC | 55150-401 | 55150-0401-25 |
| Gentamicin | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Eugia US LLC | 55150-402 | 55150-0402-25 |
| Gentamicin | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Eugia US LLC | 55150-403 | 55150-0403-25 |
| Gentamicin | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9128 | 00143-9128-25 |
| Gentamicin | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9129 | 00143-9129-10 |
| Gentamicingentamicin sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc | 0404-9866 | 00404-9866-20 |
| Gentamicin | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1508 | 51662-1508-03 |
| Gentamicin | Gentamicin sulfate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-173 | 63323-0173-02 |
| Gentamicingentamicin sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-010 | 63323-0010-9463323-0010-95 |
| Gentamicingentamicin sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7311 | 71872-7311-01 |
Other NDCs under ANDA 215237
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 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Eugia US LLC | 55150-402 |
| Gentamicin | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Eugia US LLC | 55150-403 |