What is NDC 43598-605?

43598-605 is the product NDC for Tobramycin Inhalation Solution, Tobramycin 300 mg/5mL inhalant, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Inc., NDC labeler code 43598. 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 43598-605

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-605Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0605Add 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
43598-605-56	4359806055643598060556	14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULEMarketed from May 14, 2019
43598-605-58	4359806055843598060558	56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULEMarketed from Oct 29, 2020

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 Inhalation Solution
Generic name (nonproprietary): tobramycin inhalation solution
Active ingredients: Tobramycin — 300 mg/5mL
Dosage form: Inhalant
Route: Respiratory (Inhalation)
Labeler: Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207080
Marketing start: May 14, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beedeSPL ID 946d18e8-ea8f-97c0-f49b-ec4e286beedeSPL set ID e5bbf589-d066-c89a-c40f-cbeb6f98c5b5RxCUI 348719UNII VZ8RRZ51VKUPC 0343598605111
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

N443598060556 followed by a unit qualifier and the quantity

Package 43598-0605-56. 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 Feb 1, 2023.

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 43598-605

What is NDC 43598-605?: 43598-605 is the product NDC for Tobramycin Inhalation Solution, Tobramycin 300 mg/5mL inhalant, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tobramycin Inhalation Solution.
What is the active ingredient?: Tobramycin.
Who is the labeler?: Dr. Reddy's Laboratories Inc., NDC labeler code 43598. 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)	NorthStar RxLLC	16714-119	—

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)	NorthStar RxLLC	16714-119