Gentamicin (gentamicin sulfate) NDC 63323-010

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0010Add 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
63323-010-94	63323001094	25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-94) / 2 mL in 1 VIAL, MULTI-DOSE (63323-010-41)Marketed from Aug 10, 2000
63323-010-95	63323001095	25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-95) / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42)Marketed from Aug 10, 2000

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062366
Marketing start: Aug 10, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720SPL ID 48a57ed5-3809-49cc-a7ec-715e7e2c1720SPL set ID 0cce2238-28d3-4280-b520-ffc3067a2ffaRxCUI 313996UNII 8X7386QRLVUPC 0363323010423, 0363323010416
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

N463323001094 followed by a unit qualifier and the quantity

Package 63323-0010-94. 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, 2023. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 062366

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

FDA NDC Directory listings under ANDA 062366
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
Gentamicingentamicin sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc	0404-9866
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	Medical Purchasing Solutions, LLC	71872-7311