Prescription drug · ANDA
Tobramycin (tobramycin solution) NDC 42571-408
Tobramycin 300 mg/5mL · Inhalant · Respiratory (Inhalation) · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-408-92 | 42571040892 | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09)Marketed from Jan 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 solution
- Active ingredients
- Tobramycin — 300 mg/5mL
- Dosage form
- Inhalant
- Route
- Respiratory (Inhalation)
- Labeler
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217344
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 42571-408_38f21173-d355-80a7-e063-6294a90a3643SPL ID 38f21173-d355-80a7-e063-6294a90a3643SPL set ID 9d8b7b6c-3072-48e9-87c8-51160b9df9bcRxCUI 348719UNII VZ8RRZ51VKUPC 0342571408190
- 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
N442571040892followed by a unit qualifier and the quantityPackage 42571-0408-92. 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 . ( 1 ) Safety and efficacy have not been demonstrated in patients under the age o…
Excerpt only. Read the full label for complete information.