What is NDC 51662-1597?

51662-1597 is the product NDC for Gentamicin Sulfate, Gentamicin sulfate 40 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.

HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 51662-1597 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51662-1597Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51662-1597Add 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
51662-1597-3	5166215970351662159703	25 POUCH in 1 CASE (51662-1597-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1597-2) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 1, 2022

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: HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062420
Marketing start: Oct 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 51662-1597_0ff9b5b7-53ad-15f6-e063-6394a90a82aaSPL ID 0ff9b5b7-53ad-15f6-e063-6394a90a82aaSPL set ID e9fbe619-2afe-f1d7-e053-2a95a90aab29RxCUI 1870650UNII 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 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

N451662159703 followed by a unit qualifier and the quantity

Package 51662-1597-03. 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 27, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & 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: Ps…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1597

What is NDC 51662-1597?: 51662-1597 is the product NDC for Gentamicin Sulfate, Gentamicin sulfate 40 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. 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?: HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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	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
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals, Inc.	66267-971	66267-0971-05

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
Product	Strength	Form · route	Labeler	Product NDC
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9865
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-1207
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-2392
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7216
Gentamicin Sulfate	Gentamicin sulfate 40 mg/mL	Injection, SolutionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7337