Tobramycin and Dexamethasone NDC 68788-4081

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-4081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-4081Add 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
68788-4081-5	68788408105	1 BOTTLE in 1 CARTON (68788-4081-5) / 5 mL in 1 BOTTLEMarketed from Feb 26, 2026

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: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050592
Marketing start: Feb 26, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68788-4081_8a143864-e36b-49bf-91b4-c6cc1a928031SPL ID 8a143864-e36b-49bf-91b4-c6cc1a928031SPL set ID 8a143864-e36b-49bf-91b4-c6cc1a928031RxCUI 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

N468788408105 followed by a unit qualifier and the quantity

Package 68788-4081-05. 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 Feb 26, 2026.

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)

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	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	Advanced Rx of Tennessee, LLC	80425-0366
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Sandoz Inc	61314-647