Gentamicin Sulfate NDC 63187-764

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-764Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0764Add 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
63187-764-05	63187076405	1 BOTTLE, DROPPER in 1 CARTON (63187-764-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2016

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/ drops
Route: Ophthalmic
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 064163
Marketing start: Dec 13, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 63187-764_a119d390-b228-4fce-b5a6-26a13833ace0SPL ID a119d390-b228-4fce-b5a6-26a13833ace0SPL set ID 2098faaa-7f60-4640-8c37-19456ebba653RxCUI 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

N463187076405 followed by a unit qualifier and the quantity

Package 63187-0764-05. 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 Nov 1, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Gentamicin Sulfate Sterile 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 064163

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

FDA NDC Directory listings under ANDA 064163
Product	Strength	Form · route	Labeler	Product NDC
Gentamicin Sulfate	Gentamicin sulfate 3 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals, Inc.	66267-971