NDC codes

FDA NDC Directory
Product NDC (as listed)70756-617Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70756-0617Add 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
70756-617-56707560617567075606175614 POUCH in 1 CARTON (70756-617-56) / 4 AMPULE in 1 POUCH (70756-617-44) / 4 mL in 1 AMPULEMarketed from Sep 23, 2022

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
Lifestar Pharma LLCNDC labeler code 70756
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216725
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)
Identifiers
Product ID 70756-617_e9af1897-30d0-4886-8e50-593b317c6001SPL ID e9af1897-30d0-4886-8e50-593b317c6001SPL set ID 96517b44-55df-4d2c-8fe8-110ed51dfafeRxCUI 1314763UNII VZ8RRZ51VKUPC 0370756617563, 0370756617440
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

N470756061756 followed by a unit qualifier and the quantity

Package 70756-0617-56. 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 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 70756-617

What is NDC 70756-617?
70756-617 is the product NDC for Tobramycin, Tobramycin 300 mg/4mL solution, listed with the FDA by Lifestar Pharma LLC. 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?
Lifestar Pharma LLC, NDC labeler code 70756. 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/5mLSolutionRespiratory (Inhalation)NorthStar RxLLC72603-43072603-0430-56
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

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
ProductStrengthForm · routeLabelerProduct NDC
TobramycinTobramycin 300 mg/4mLSolutionRespiratory (Inhalation)NorthStar RxLLC72603-630

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