Gentamicin (Gentamicin sulfate) NDC 63323-010

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, LLCNDC labeler code 63323

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 062366

Marketing start

Aug 10, 2000

Listing expires

Dec 31, 2027

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 Copy

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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 63323-010

What is NDC 63323-010?

63323-010 is the product NDC for Gentamicin (gentamicin sulfate), Gentamicin sulfate 40 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Gentamicin (Gentamicin sulfate).

What is the active ingredient?

Gentamicin sulfate.

Who is the labeler?

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.

Other NDCs under ANDA 062366

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