Prescription drug · ANDA
Tobramycin NDC 72603-630
Tobramycin 300 mg/4mL · Solution · Respiratory (Inhalation) · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-630-56 | 72603063056 | 14 POUCH in 1 CARTON (72603-630-56) / 4 AMPULE in 1 POUCH (72603-630-04) / 4 mL in 1 AMPULEMarketed from Aug 1, 2024 |
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/4mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216725
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 72603-630_9bb2abbd-9e7c-401e-ab46-4bcbd51c8bd7SPL ID 9bb2abbd-9e7c-401e-ab46-4bcbd51c8bd7SPL set ID 634efd82-1a35-40cf-9893-50c27d661083RxCUI 1314763UNII VZ8RRZ51VKUPC 0372603630565
- 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
N472603063056followed by a unit qualifier and the quantityPackage 72603-0630-56. 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 patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. Tobramycin inhalation solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. ( 1 ) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV 1 ) less than 40% or greater than 80…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216725
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/4mL | SolutionRespiratory (Inhalation) | Lifestar Pharma LLC | 70756-617 |