Tobramycin and Dexamethasone NDC 70518-3994

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3994Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3994Add 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
70518-3994-0	70518399400	5 mL in 1 BOTTLE (70518-3994-0)Marketed from Jan 24, 2024

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: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050592
Marketing start: Jan 24, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 70518-3994_53ff0e42-cb1a-af38-e063-6294a90a1ec3SPL ID 53ff0e42-cb1a-af38-e063-6294a90a1ec3SPL set ID c606945c-4ffc-4ee8-af04-a00de8ea9259RxCUI 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

N470518399400 followed by a unit qualifier and the quantity

Package 70518-3994-00. 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	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	Advanced Rx of Tennessee, LLC	80425-0366
Tobramycin and Dexamethasone	Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL	Suspension/ dropsOphthalmic	Sandoz Inc	61314-647