What is NDC 0078-0876?

0078-0876 is the product NDC for TobraDex, Tobramycin 3 mg/g; Dexamethasone 1 mg/g ointment, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for TobraDex?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

TobraDex NDC 0078-0876 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0876Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0876Add 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
0078-0876-01	0007808760100078087601	3.5 g in 1 TUBE (0078-0876-01)Marketed from Oct 27, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): TobraDex
Generic name (nonproprietary): tobramycin and dexamethasone
Active ingredients: Tobramycin — 3 mg/gDexamethasone — 1 mg/g
Dosage form: Ointment
Route: Ophthalmic
Labeler: Novartis Pharmaceuticals CorporationNDC labeler code 0078
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050616
Marketing start: Oct 15, 1988
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0078-0876_81fcc79f-0170-4a8c-a938-f440a3d48dbfSPL ID 81fcc79f-0170-4a8c-a938-f440a3d48dbfSPL set ID 7f310e0e-0d3b-493d-b6c4-238493a2a9b9RxCUI 208821, 309682UNII 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

N400078087601 followed by a unit qualifier and the quantity

Package 00078-0876-01. 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 22, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) 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 for…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-0876

What is NDC 0078-0876?: 0078-0876 is the product NDC for TobraDex, Tobramycin 3 mg/g; Dexamethasone 1 mg/g ointment, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: TobraDex (Tobramycin and dexamethasone).
What is the active ingredient?: Tobramycin, Dexamethasone.
Who is the labeler?: Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TobraDex?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

TobraDex (Tobramycin and dexamethasone) NDC 0078-0876