Kitabis Pak (tobramycin) NDC 24492-850

NDC codes

FDA NDC Directory

Product NDC (as listed)24492-850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24492-0850Add 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 NDC	11-digit (billing)	Package	Copy
24492-850-56	24492085056	14 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULEMarketed from Feb 19, 2015

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): Kitabis Pak
Generic name (nonproprietary): tobramycin
Active ingredients: Tobramycin — 300 mg/5mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Pari Respiratory Equipment, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205433
Marketing start: Feb 19, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 24492-850_49aa9935-4371-43a5-a681-f7a5725b1b2bSPL ID 49aa9935-4371-43a5-a681-f7a5725b1b2bSPL set ID da1e5afd-d707-4af1-8935-8195ba6d769fRxCUI 348719, 1596030UNII 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

N424492085056 followed by a unit qualifier and the quantity

Package 24492-0850-56. 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 Nov 22, 2024.

Indications (excerpt from the label)

KITABIS PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV 1 < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )]. KITABIS PAK contains tobramycin, an aminoglycoside antibacterial drug indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 205433

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 205433
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin Inhalation Solution Paktobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	Genericus, Inc.	70644-899