What is NDC 72603-630?

72603-630 is the product NDC for Tobramycin, Tobramycin 300 mg/4mL solution, listed with the FDA by NorthStar RxLLC. It has 1 package NDC, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobramycin NDC 72603-630 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72603-630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72603-0630Add 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
72603-630-56	7260306305672603063056	14 POUCH in 1 CARTON (72603-630-56) / 4 AMPULE in 1 POUCH (72603-630-04) / 4 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/4mL
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 216725
Marketing start: Aug 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 72603-630_9bb2abbd-9e7c-401e-ab46-4bcbd51c8bd7SPL ID 9bb2abbd-9e7c-401e-ab46-4bcbd51c8bd7SPL set ID 634efd82-1a35-40cf-9893-50c27d661083RxCUI 1314763UNII VZ8RRZ51VKUPC 0372603630565
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

N472603063056 followed by a unit qualifier and the quantity

Package 72603-0630-56. 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 Jun 24, 2024.

Indications (excerpt from the label)

Tobramycin inhalation solution 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 six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. Tobramycin inhalation solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. ( 1 ) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV 1 ) less than 40% or greater than 80…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72603-630

What is NDC 72603-630?: 72603-630 is the product NDC for Tobramycin, Tobramycin 300 mg/4mL 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tobramycin	Tobramycin 3 mg/mL	SolutionOphthalmic	Preferred Pharmaceuticals Inc.	68788-4149	68788-4149-05
Tobramycin	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	JVET PHARMACEUTICALS LLC	86211-110	86211-0110-01
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	Ritedose Pharmaceuticals, LLC	76204-029	76204-0029-56
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	NorthStar RxLLC	72603-430	72603-0430-56
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	American Health Packaging	60687-731	60687-0731-83
Tobramycin	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	Belcher Pharmaceuticals, LLC	62250-110	62250-0110-01
Tobramycin	Tobramycin sulfate 1.2 g/30mL	Injection, Powder, Lyophilized, For solutionIntravenous	Northstar Rx LLC	72603-160	72603-0160-06
Tobramycintobramycin solution	Tobramycin 300 mg/5mL	InhalantRespiratory (Inhalation)	Micro Labs Limited	42571-408	42571-0408-92
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	Lifestar Pharma LLC	70756-604	70756-0604-56
Tobramycin	Tobramycin sulfate 1.2 g/30mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-470	55150-0470-06

All 55 Tobramycin NDCs

Other NDCs under ANDA 216725

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

FDA NDC Directory listings under ANDA 216725
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin	Tobramycin 300 mg/4mL	SolutionRespiratory (Inhalation)	Lifestar Pharma LLC	70756-617