Prescription drug · ANDA
Tobramycin Inhalation Solution NDC 16714-119
Tobramycin 300 mg/5mL · Inhalant · Respiratory (Inhalation) · NorthStar RxLLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Tobramycin Inhalation Solution
- Generic name (nonproprietary)
- tobramycin inhalation solution
- Active ingredients
- Tobramycin — 300 mg/5mL
- Dosage form
- Inhalant
- Route
- Respiratory (Inhalation)
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207080
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 16714-119_6502d04c-fcb7-fa1f-2ca5-33cbc66ffe9bSPL ID 6502d04c-fcb7-fa1f-2ca5-33cbc66ffe9bSPL set ID 3d044738-a715-fdee-7849-521e8981e6ecRxCUI 348719UNII VZ8RRZ51VKUPC 0316714119021
- 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Tobramycin inhalation solution 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 ) ]. Tobramycin inhalation solution 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 o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207080
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tobramycin Inhalation Solution | Tobramycin 300 mg/5mL | InhalantRespiratory (Inhalation) | Dr. Reddy's Laboratories Inc. | 43598-605 |