Prescription drug · NDA
Tobi (tobramycin) NDC 49502-345
Tobramycin 300 mg/5mL · Solution · Oral, Respiratory (Inhalation) · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49502-345-73 | 49502034573 | 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 | 49502034574 | 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 LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050753
- Marketing start
- Listing expires
- 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
N449502034573followed by a unit qualifier and the quantityPackage 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 .
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.