What is NDC 16714-119?

16714-119 is the product NDC for Tobramycin Inhalation Solution, Tobramycin 300 mg/5mL inhalant, listed with the FDA by NorthStar RxLLC.

NorthStar RxLLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tobramycin Inhalation Solution?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobramycin Inhalation Solution NDC 16714-119

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-119Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0119Add the package segment from the table below.

Product information

Brand name (proprietary): Tobramycin Inhalation Solution
Generic name (nonproprietary): tobramycin inhalation solution
Active ingredients: Tobramycin — 300 mg/5mL
Dosage form: Inhalant
Route: Respiratory (Inhalation)
Labeler: NorthStar RxLLCNDC labeler code 16714
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207080
Marketing start: May 21, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 16714-119_6502d04c-fcb7-fa1f-2ca5-33cbc66ffe9bSPL ID 6502d04c-fcb7-fa1f-2ca5-33cbc66ffe9bSPL set ID 3d044738-a715-fdee-7849-521e8981e6ecRxCUI 348719UNII VZ8RRZ51VKUPC 0316714119021
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.

Product label

Current FDA label (SPL), effective Jul 9, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 16714-119

What is NDC 16714-119?: 16714-119 is the product NDC for Tobramycin Inhalation Solution, Tobramycin 300 mg/5mL inhalant, listed with the FDA by NorthStar RxLLC.
What drug is associated with this NDC?: Tobramycin Inhalation Solution.
What is the active ingredient?: Tobramycin.
Who is the labeler?: NorthStar RxLLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tobramycin Inhalation Solution?: 1 other product NDC are listed under this name. See all Tobramycin Inhalation Solution NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tobramycin Inhalation Solution NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tobramycin Inhalation Solution	Tobramycin 300 mg/5mL	InhalantRespiratory (Inhalation)	Dr. Reddy's Laboratories Inc.	43598-605	43598-0605-5643598-0605-58

Other NDCs under ANDA 207080

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

FDA NDC Directory listings under ANDA 207080
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin Inhalation Solution	Tobramycin 300 mg/5mL	InhalantRespiratory (Inhalation)	Dr. Reddy's Laboratories Inc.	43598-605