What is NDC 49502-345?

49502-345 is the product NDC for Tobi (tobramycin), Tobramycin 300 mg/5mL solution, listed with the FDA by Viatris Specialty LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tobi?

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.

Tobi NDC 49502-345 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49502-345Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49502-0345Add 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
49502-345-73	4950203457349502034573	56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULEMarketed from Jun 23, 2022
49502-345-74	4950203457449502034574	56 POUCH in 1 CARTON (49502-345-74) / 14 AMPULE in 1 POUCH (49502-345-01) / 5 mL in 1 AMPULEMarketed from Jun 25, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Tobi
Generic name (nonproprietary): tobramycin
Active ingredients: Tobramycin — 300 mg/5mL
Dosage form: Solution
Route: Oral, Respiratory (Inhalation)
Labeler: Viatris Specialty LLCNDC labeler code 49502
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050753
Marketing start: Jun 23, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 49502-345_abdb1d21-5989-4e31-8036-18a82673eaadSPL ID abdb1d21-5989-4e31-8036-18a82673eaadSPL set ID 6a3c3871-1d3a-44d6-8be3-526b30123ef7RxCUI 213194, 348719UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N449502034573 followed by a unit qualifier and the quantity

Package 49502-0345-73. 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 Nov 15, 2025.

Indications (excerpt from the label)

TOBI is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. TOBI is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa . ( 1 ) Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49502-345

What is NDC 49502-345?: 49502-345 is the product NDC for Tobi (tobramycin), Tobramycin 300 mg/5mL solution, listed with the FDA by Viatris Specialty LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tobi (Tobramycin).
What is the active ingredient?: Tobramycin.
Who is the labeler?: Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tobi?: 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.

Tobi (Tobramycin) NDC 49502-345