Prescription drug · NDA
TOBI Podhaler (tobramycin) NDC 49502-401
Tobramycin 28 mg/1 · Capsule · Oral, Respiratory (Inhalation) · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49502-401-09 | 49502040109 | 8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09)Marketed from Oct 4, 2022 · Sample package | |
| 49502-401-24 | 49502040124 | 4 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 7 BLISTER PACK in 1 PACKAGE / 8 CAPSULE in 1 BLISTER PACKMarketed from Sep 1, 2021 | |
| 49502-401-57 | 49502040157 | 7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-401-57) / 8 CAPSULE in 1 BLISTER PACKMarketed from Oct 4, 2022 · Sample package |
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 Podhaler
- Generic name (nonproprietary)
- tobramycin
- Active ingredients
- Tobramycin — 28 mg/1
- Dosage form
- Capsule
- Route
- Oral, Respiratory (Inhalation)
- Labeler
- Viatris Specialty LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201688
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 49502-401_20d6d1c8-8974-4166-b224-d3b7e0c202d6SPL ID 20d6d1c8-8974-4166-b224-d3b7e0c202d6SPL set ID c4b5bb1f-e158-4ac1-9c35-e98a416c743aRxCUI 1374569, 1374570, 1374573, 1374574, 1661466, 1661559, 1661560, 1661567UNII 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
N449502040109followed by a unit qualifier and the quantityPackage 49502-0401-09. 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 Podhaler 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 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ] . TOBI Podhaler is an aminoglycoside antibacterial indicated for the management of cystic fibrosis patients 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 >80%, or patients colonized with Burkholderia cepacia ( 1 )…
Excerpt only. Read the full label for complete information.