Gentamicin Sulfate NDC 45802-056

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-056Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0056Add 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
45802-056-11	45802005611	1 TUBE in 1 CARTON (45802-056-11) / 30 g in 1 TUBEMarketed from Aug 23, 2006
45802-056-35	45802005635	1 TUBE in 1 CARTON (45802-056-35) / 15 g in 1 TUBEMarketed from Dec 5, 2006

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 Sulfate
Generic name (nonproprietary): gentamicin sulfate
Active ingredients: Gentamicin sulfate — 1 mg/g
Dosage form: Cream
Route: Topical
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062307
Marketing start: Aug 23, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 45802-056_11688357-e569-4785-a313-18115f24c5bbSPL ID 11688357-e569-4785-a313-18115f24c5bbSPL set ID 4cfbe37e-11d6-46fc-b287-0561387b17b7RxCUI 197735UNII 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N445802005611 followed by a unit qualifier and the quantity

Package 45802-0056-11. 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 Jan 31, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. Please Note: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. It is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact be…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)