Tobramycin NDC 68083-374

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-374Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0374Add 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
68083-374-01	68083037401	1 BOTTLE, PLASTIC in 1 CARTON (68083-374-01) / 5 mL in 1 BOTTLE, PLASTICMarketed from Mar 9, 2021

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): Tobramycin
Generic name (nonproprietary): tobramycin
Active ingredients: Tobramycin — 3 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212628
Marketing start: Mar 9, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 68083-374_f43b227e-3e24-428d-bef1-4f32628a786eSPL ID f43b227e-3e24-428d-bef1-4f32628a786eSPL set ID f8c92d73-711a-423f-bf34-bdec4464828eRxCUI 313415UNII VZ8RRZ51VKUPC 0368083374013
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

N468083037401 followed by a unit qualifier and the quantity

Package 68083-0374-01. 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 Jul 27, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tobramycin ophthalmic solution 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212628

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

FDA NDC Directory listings under ANDA 212628
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	JVET PHARMACEUTICALS LLC	86211-110
Tobramycin	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	Belcher Pharmaceuticals, LLC	62250-110