NDC codes

FDA NDC Directory
Product NDC (as listed)63187-973Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0973Add 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
63187-973-0563187097305631870973055 mL in 1 BOTTLE, PLASTIC (63187-973-05)Marketed from Jan 1, 2018

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 — 3 mg/mL
Dosage form
Solution
Route
Ophthalmic
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 062535
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)
Identifiers
Product ID 63187-973_3439b089-5661-47e1-87e9-7b18c7d61540SPL ID 3439b089-5661-47e1-87e9-7b18c7d61540SPL set ID 4eb4dfd1-f3ae-4400-b043-910b4c77296bRxCUI 313415UNII 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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463187097305 followed by a unit qualifier and the quantity

Package 63187-0973-05. 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)

INDICATIONS AND USAGE Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-973

What is NDC 63187-973?
63187-973 is the product NDC for Tobramycin, Tobramycin 3 mg/mL solution, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 63187. 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?
55 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)NorthStar RxLLC72603-43072603-0430-56
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)American Health Packaging60687-73160687-0731-83
TobramycinTobramycin sulfate 1.2 g/30mLInjection, Powder, Lyophilized, For solutionIntravenousNorthstar Rx LLC72603-16072603-0160-06
TobramycinTobramycin 3 mg/mLSolution/ dropsOphthalmicBelcher Pharmaceuticals, LLC62250-11062250-0110-01
Tobramycintobramycin solutionTobramycin 300 mg/5mLInhalantRespiratory (Inhalation)Micro Labs Limited42571-40842571-0408-92
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)Lifestar Pharma LLC70756-60470756-0604-56

All 56 Tobramycin NDCs

Other NDCs under ANDA 062535

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

FDA NDC Directory listings under ANDA 062535
ProductStrengthForm · routeLabelerProduct NDC
TobramycinTobramycin 3 mg/mLSolutionOphthalmicSandoz Inc61314-643

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