NDC codes

FDA NDC Directory
Product NDC (as listed)60687-731Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0731Add 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
60687-731-83606870731836068707318330 POUCH in 1 CARTON (60687-731-83) / 1 AMPULE in 1 POUCH (60687-731-79) / 5 mL in 1 AMPULEMarketed from May 19, 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
American Health PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207136
Marketing start
Marketing end
Other FDA classes
Aminoglycosides (Chemical structure)
Identifiers
Product ID 60687-731_468bc4c2-5d73-2339-e063-6394a90ad327SPL ID 468bc4c2-5d73-2339-e063-6394a90ad327SPL set ID f2f8bf02-57f8-4d34-937a-32411fc6bfbaRxCUI 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

N460687073183 followed by a unit qualifier and the quantity

Package 60687-0731-83. 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 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 of 6 years, patients with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60687-731

What is NDC 60687-731?
60687-731 is the product NDC for Tobramycin, Tobramycin 300 mg/5mL solution, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 60687. 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 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 207136

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

FDA NDC Directory listings under ANDA 207136
ProductStrengthForm · routeLabelerProduct NDC
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)Sun Pharmaceutical Industries, Inc.47335-171

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