Gentamicin Sulfate NDC 68071-3554

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3554Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3554Add 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
68071-3554-5	68071355405	1 BOTTLE, DROPPER in 1 CARTON (68071-3554-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Dec 7, 2023

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 — 3 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 064048
Marketing start: May 11, 1994
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 68071-3554_2d3fc60b-5a42-6abc-e063-6394a90af2a0SPL ID 2d3fc60b-5a42-6abc-e063-6394a90af2a0SPL set ID 0bef2a01-69d0-cf50-e063-6294a90a4c52RxCUI 310467UNII 8X7386QRLVUPC 0368071355451
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468071355405 followed by a unit qualifier and the quantity

Package 68071-3554-05. 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 Feb 3, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 064048

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 064048
Product	Strength	Form · route	Labeler	Product NDC
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	63187-560
Gentamicin Sulfate Opth Solution	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Direct_Rx	72189-359
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Asclemed USA, Inc.	76420-254
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-0569
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-580
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-8592