NDC codes

FDA NDC Directory
Product NDC (as listed)55154-2392Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-2392Add 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 NDC11-digit (billing)PackageCopy
55154-2392-555154239205551542392055 VIAL, SINGLE-DOSE in 1 BAG (55154-2392-5) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 29, 2005

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 Sulfate
Generic name (nonproprietary)
gentamicin sulfate
Active ingredients
Gentamicin sulfate — 40 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous
Labeler
Cardinal Health 107, LLCNDC labeler code 55154
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 062420
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)
Identifiers
Product ID 55154-2392_77f135ab-2291-487d-a9e2-50818624fa1aSPL ID 77f135ab-2291-487d-a9e2-50818624fa1aSPL set ID 5113bfad-42ca-4bb8-9343-0b08c6cd03f0RxCUI 1870650UNII 8X7386QRLVUPC 0055154239257
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

N455154239205 followed by a unit qualifier and the quantity

Package 55154-2392-05. 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 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)

About NDC 55154-2392

What is NDC 55154-2392?
55154-2392 is the product NDC for Gentamicin Sulfate, Gentamicin sulfate 40 mg/mL injection, solution, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gentamicin Sulfate.
What is the active ingredient?
Gentamicin sulfate.
Who is the labeler?
Cardinal Health 107, LLC, NDC labeler code 55154. 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 Sulfate?
25 other product NDCs are listed under this name. See all Gentamicin Sulfate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Gentamicin Sulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Gentamicin SulfateGentamicin sulfate 1 mg/gOintmentTopicalEncube Ethicals, Inc.21922-11021922-0110-0421922-0110-05
Gentamicin SulfateGentamicin sulfate 3 mg/mLSolution/ dropsOphthalmicPreferred Pharmaceuticals Inc.68788-859268788-8592-05
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousHF Acquisition Co LLC, DBA HealthFirst51662-159751662-1597-03
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousHenry Schein, Inc.0404-986500404-9865-02
Gentamicin SulfateGentamicin sulfate 1 mg/gCreamTopicalCosette Pharmaceuticals, Inc.0713-068300713-0683-1500713-0683-31
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousMedical Purchasing Solutions, LLC71872-721671872-7216-01
Gentamicin SulfateGentamicin sulfate 1 mg/gOintmentTopicalCosette Pharmaceuticals, Inc.0713-068200713-0682-1500713-0682-31
Gentamicin SulfateGentamicin sulfate 1 mg/gOintmentTopicalProficient Rx LP71205-56071205-0560-15
gentamicin sulfateGentamicin sulfate 3 mg/mLSolution/ dropsOphthalmicDIRECT RX61919-10661919-0106-05
Gentamicin SulfateGentamicin sulfate 3 mg/mLSolution/ dropsOphthalmicProficient Rx LP63187-76463187-0764-05

All 26 Gentamicin Sulfate NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousHenry Schein, Inc.0404-9865
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-1207
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1597
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousMedical Purchasing Solutions, LLC71872-7216
Gentamicin SulfateGentamicin sulfate 40 mg/mLInjection, SolutionIntramuscular, IntravenousMedical Purchasing Solutions, LLC71872-7337

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