What is NDC 0078-0813?

0078-0813 is the product NDC for Tobrex (tobramycin), Tobramycin 3 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 Tobrex?

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.

Tobrex NDC 0078-0813 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0813Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0813Add 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
0078-0813-01	0007808130100078081301	3.5 g in 1 TUBE (0078-0813-01)Marketed from Mar 8, 2022

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): Tobrex
Generic name (nonproprietary): tobramycin
Active ingredients: Tobramycin — 3 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 050555
Marketing start: Jun 28, 1981
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 0078-0813_5e274c59-a22a-43a1-a3bd-b4f128dbee31SPL ID 5e274c59-a22a-43a1-a3bd-b4f128dbee31SPL set ID 5b66bba3-cf97-4a9c-b618-ba5f277f20f6RxCUI 207850, 313414UNII VZ8RRZ51VK
Pharmacologic class: Aminoglycoside Antibacterial

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

N400078081301 followed by a unit qualifier and the quantity

Package 00078-0813-01. 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 16, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE TOBREX ® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0078-0813

What is NDC 0078-0813?: 0078-0813 is the product NDC for Tobrex (tobramycin), Tobramycin 3 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?: Tobrex (Tobramycin).
What is the active ingredient?: Tobramycin.
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 Tobrex?: 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.

Tobrex (Tobramycin) NDC 0078-0813