Prescription drug · ANDA
Gentamicin Sulfate NDC 45802-046
Gentamicin sulfate 1 mg/g · Ointment · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-046-11 | 45802004611 | 1 TUBE in 1 CARTON (45802-046-11) / 30 g in 1 TUBEMarketed from Aug 28, 2006 | |
| 45802-046-35 | 45802004635 | 1 TUBE in 1 CARTON (45802-046-35) / 15 g in 1 TUBEMarketed from Jul 10, 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
- Ointment
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062351
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5SPL ID 551f1c2e-36a3-4229-b70f-38b6a3faa1d5SPL set ID a9486ae1-350b-41c5-ae0c-a4d692bb2dfdRxCUI 310465UNII 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
N445802004611followed by a unit qualifier and the quantityPackage 45802-0046-11. 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 .
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. 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 between t…
Excerpt only. Read the full label for complete information.