Gentamicin Sulfate NDC 61314-633

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-633Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0633Add 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
61314-633-05	61314063305	1 BOTTLE, DROPPER in 1 CARTON (61314-633-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 5, 1996

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 — 3 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062196
Marketing start: Apr 5, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 61314-633_a628d79b-79de-49ec-b116-c605ba0fb991SPL ID a628d79b-79de-49ec-b116-c605ba0fb991SPL set ID a213fb9c-08ea-4f30-a6c9-93c7a9ba5280RxCUI 310467UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N461314063305 followed by a unit qualifier and the quantity

Package 61314-0633-05. 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 Jan 2, 2024.

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 062196

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

FDA NDC Directory listings under ANDA 062196
Product	Strength	Form · route	Labeler	Product NDC
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	SolutionOphthalmic	Proficient Rx LP	71205-333
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	SolutionOphthalmic	NuCare Pharmaceuticals,Inc.	68071-4775
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	SolutionOphthalmic	Asclemed USA, Inc.	76420-137