NDC codes

FDA NDC Directory
Product NDC (as listed)72603-430Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72603-0430Add 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
72603-430-56726030430567260304305614 POUCH in 1 CARTON (72603-430-56) / 4 AMPULE in 1 POUCH (72603-430-04) / 5 mL in 1 AMPULEMarketed from Aug 1, 2024

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
Generic name (nonproprietary)
tobramycin
Active ingredients
Tobramycin — 300 mg/5mL
Dosage form
Solution
Route
Respiratory (Inhalation)
Labeler
NorthStar RxLLCNDC labeler code 72603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214478
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)
Identifiers
Product ID 72603-430_98c53b08-1ee0-42d8-89a7-1443b7a7f440SPL ID 98c53b08-1ee0-42d8-89a7-1443b7a7f440SPL set ID 7803ac83-1250-451b-8ad8-2c0a343c3031RxCUI 348719UNII 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

N472603043056 followed by a unit qualifier and the quantity

Package 72603-0430-56. 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 .

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. Safety and efficacy have not been demonstrated in patients under the age of 6 year…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72603-430

What is NDC 72603-430?
72603-430 is the product NDC for Tobramycin, Tobramycin 300 mg/5mL solution, listed with the FDA by NorthStar RxLLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tobramycin.
What is the active ingredient?
Tobramycin.
Who is the labeler?
NorthStar RxLLC, NDC labeler code 72603. 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?
54 other product NDCs are listed under this name. See all Tobramycin 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TobramycinTobramycin 3 mg/mLSolutionOphthalmicPreferred Pharmaceuticals Inc.68788-414968788-4149-05
TobramycinTobramycin 3 mg/mLSolution/ dropsOphthalmicJVET PHARMACEUTICALS LLC86211-11086211-0110-01
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)Ritedose Pharmaceuticals, LLC76204-02976204-0029-56
TobramycinTobramycin 300 mg/4mLSolutionRespiratory (Inhalation)NorthStar RxLLC72603-63072603-0630-56
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)American Health Packaging60687-73160687-0731-83
TobramycinTobramycin 3 mg/mLSolution/ dropsOphthalmicBelcher Pharmaceuticals, LLC62250-11062250-0110-01
TobramycinTobramycin sulfate 1.2 g/30mLInjection, Powder, Lyophilized, For solutionIntravenousNorthstar Rx LLC72603-16072603-0160-06
Tobramycintobramycin solutionTobramycin 300 mg/5mLInhalantRespiratory (Inhalation)Micro Labs Limited42571-40842571-0408-92
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)Lifestar Pharma LLC70756-60470756-0604-56
TobramycinTobramycin sulfate 1.2 g/30mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-47055150-0470-06

All 55 Tobramycin NDCs

Other NDCs under ANDA 214478

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

FDA NDC Directory listings under ANDA 214478
ProductStrengthForm · routeLabelerProduct NDC
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)Lifestar Pharma LLC70756-604

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