Prescription drug · ANDA
Tobramycin NDC 70756-604
Tobramycin 300 mg/5mL · Solution · Respiratory (Inhalation) · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-604-56 | 70756060456 | 14 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULEMarketed from Jun 30, 2023 |
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)
- Tobramycin
- Generic name (nonproprietary)
- tobramycin
- Active ingredients
- Tobramycin — 300 mg/5mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Lifestar Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214478
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 70756-604_68bf90c8-847a-4ea3-8855-c7b380f994ddSPL ID 68bf90c8-847a-4ea3-8855-c7b380f994ddSPL set ID 5563e8af-c6c9-42a2-974d-7d364a47f00aRxCUI 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
N470756060456followed by a unit qualifier and the quantityPackage 70756-0604-56. 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)
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. Safety and efficacy have not been demonstrated in patients under the age of 6 year…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214478
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 | Tobramycin 300 mg/5mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-430 |