Tobramycin and Dexamethasone NDC 80425-0366

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0366Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0366Add 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
80425-0366-1	80425036601	5 mL in 1 BOTTLE (80425-0366-1)Marketed from Nov 2, 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): Tobramycin and Dexamethasone
Generic name (nonproprietary): tobramycin and dexamethasone
Active ingredients: Tobramycin — 3 mg/mLDexamethasone — 1 mg/mL
Dosage form: Suspension/ drops
Route: Ophthalmic
Labeler: Advanced Rx of Tennessee, LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050592
Marketing start: Nov 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 80425-0366_2a998d83-7bae-3f5e-e063-6294a90acd3dSPL ID 2a998d83-7bae-3f5e-e063-6294a90acd3dSPL set ID 09315f0b-f15a-30d5-e063-6394a90ac8ddRxCUI 309683UNII VZ8RRZ51VK, 7S5I7G3JQL
Pharmacologic class: Aminoglycoside Antibacterial; Corticosteroid

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

N480425036601 followed by a unit qualifier and the quantity

Package 80425-0366-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 050592

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

FDA NDC Directory listings under NDA 050592
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	REMEDYREPACK INC.	70518-3994
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-4081
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	A-S Medication Solutions	50090-1135
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	A-S Medication Solutions	50090-1136
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Sandoz Inc	61314-647