What is NDC 80425-0260?

80425-0260 is the product NDC for Tobramycin and dexamethasone, Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tobramycin and dexamethasone?

23 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobramycin and dexamethasone NDC 80425-0260

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0260Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0260Add 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
80425-0260-1	8042502600180425026001	5 mL in 1 BOTTLE, PLASTIC (80425-0260-1)Marketed from Feb 15, 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 Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212715
Marketing start: Feb 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 80425-0260_2a9b792b-f417-e859-e063-6394a90a30e2SPL ID 2a9b792b-f417-e859-e063-6394a90a30e2SPL set ID f4c00d9c-3a17-06a0-e053-2a95a90a8413RxCUI 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

N480425026001 followed by a unit qualifier and the quantity

Package 80425-0260-01. 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 Dec 31, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0260

What is NDC 80425-0260?: 80425-0260 is the product NDC for Tobramycin and dexamethasone, Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tobramycin and dexamethasone.
What is the active ingredient?: Tobramycin, Dexamethasone.
Who is the labeler?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tobramycin and dexamethasone?: 23 other product NDCs are listed under this name. See all Tobramycin and dexamethasone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tobramycin and dexamethasone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-4081	68788-4081-05
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	REMEDYREPACK INC.	70518-3994	70518-3994-00
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Advanced Rx of Tennessee, LLC	80425-0366	80425-0366-01
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Padagis US LLC	0574-4031	00574-4031-0500574-4031-1000574-4031-25
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	A-S Medication Solutions	50090-7267	50090-7267-00
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	A-S Medication Solutions	50090-8046	50090-8046-00
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	63629-9570	63629-9570-01
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	63629-9571	63629-9571-01
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	63629-9572	63629-9572-01
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Redpharm Drug	67296-2174	67296-2174-05

All 24 Tobramycin and dexamethasone NDCs

Other NDCs under ANDA 212715

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

FDA NDC Directory listings under ANDA 212715
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	72162-1128
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	71335-2840
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Padagis US LLC	0574-4031
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	71335-2854
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Redpharm Drug	67296-2174
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	A-S Medication Solutions	50090-8046
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	71335-2891
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	A-S Medication Solutions	50090-7267
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	63629-9572
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	63629-9570
Tobramycin And Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	63629-9571