What is NDC 45802-046?

45802-046 is the product NDC for Gentamicin Sulfate, Gentamicin sulfate 1 mg/g ointment, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gentamicin Sulfate NDC 45802-046 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-046Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0046Add 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
45802-046-11	4580200461145802004611	1 TUBE in 1 CARTON (45802-046-11) / 30 g in 1 TUBEMarketed from Aug 28, 2006
45802-046-35	4580200463545802004635	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
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062351
Marketing start: Jul 10, 2006
Listing expires: Dec 31, 2026
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

N445802004611 followed by a unit qualifier and the quantity

Package 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 Jan 15, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 45802-046

What is NDC 45802-046?: 45802-046 is the product NDC for Gentamicin Sulfate, Gentamicin sulfate 1 mg/g ointment, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, 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?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	OintmentTopical	Encube Ethicals, Inc.	21922-110	21922-0110-0421922-0110-05
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-8592	68788-8592-05
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1597	51662-1597-03
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9865	00404-9865-02
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	CreamTopical	Cosette Pharmaceuticals, Inc.	0713-0683	00713-0683-1500713-0683-31
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7216	71872-7216-01
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	OintmentTopical	Cosette Pharmaceuticals, Inc.	0713-0682	00713-0682-1500713-0682-31
Gentamicin Sulfate	Gentamicin sulfate 1 mg/g	OintmentTopical	Proficient Rx LP	71205-560	71205-0560-15
gentamicin sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	DIRECT RX	61919-106	61919-0106-05
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	63187-764	63187-0764-05

All 26 Gentamicin Sulfate NDCs