NDC codes

FDA NDC Directory
Product NDC (as listed)49502-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49502-0401Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49502-401-0949502040109495020401098 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09)Marketed from Oct 4, 2022 · Sample package
49502-401-2449502040124495020401244 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
49502-401-5749502040157495020401577 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 LLCNDC labeler code 49502
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

N449502040109 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 49502-401

What is NDC 49502-401?
49502-401 is the product NDC for TOBI Podhaler (tobramycin), Tobramycin 28 mg/1 capsule, listed with the FDA by Viatris Specialty LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TOBI Podhaler (Tobramycin).
What is the active ingredient?
Tobramycin.
Who is the labeler?
Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TOBI Podhaler?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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