Gentamicin Sulfate NDC 0404-9865

NDC codes

FDA NDC Directory

Product NDC (as listed)0404-9865Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00404-9865Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0404-9865-02	00404986502	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9865-02) / 2 mL in 1 VIAL, SINGLE-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 Sulfate
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 062420
Marketing start: Jan 10, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 0404-9865_fa19ae2a-f30b-484f-b702-0e13b5431c33SPL ID fa19ae2a-f30b-484f-b702-0e13b5431c33SPL set ID 913a36c3-50d6-429a-a8dd-a03126d2ca08RxCUI 1870650UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N400404986502 followed by a unit qualifier and the quantity

Package 00404-9865-02. 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 Oct 31, 2025. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 062420

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 062420
Product	Strength	Form · route	Labeler	Product NDC
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	HF Acquisition Co LLC, DBA HealthFirst	51662-1597
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7337
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-2392
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-1207