What is NDC 61314-643?

61314-643 is the product NDC for Tobramycin, Tobramycin 3 mg/mL solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 61314. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobramycin NDC 61314-643 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0643Add 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
61314-643-05	6131406430561314064305	5 mL in 1 BOTTLE, PLASTIC (61314-643-05)Marketed from Jan 9, 1995

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: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062535
Marketing start: Jan 9, 1995
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 61314-643_505c82ff-86c3-4269-96cb-faae872c7539SPL ID 505c82ff-86c3-4269-96cb-faae872c7539SPL set ID 27e2c16e-19b0-4745-93eb-5cf99f94bb92RxCUI 313415UNII VZ8RRZ51VKUPC 0361314643056
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

N461314064305 followed by a unit qualifier and the quantity

Package 61314-0643-05. 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 Aug 31, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tobramycin ophthalmic solution, 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, 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 61314-643

What is NDC 61314-643?: 61314-643 is the product NDC for Tobramycin, Tobramycin 3 mg/mL solution, listed with the FDA by Sandoz Inc. 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?: Sandoz Inc, NDC labeler code 61314. 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
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/4mL	SolutionRespiratory (Inhalation)	NorthStar RxLLC	72603-630	72603-0630-56
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 sulfate 1.2 g/30mL	Injection, Powder, Lyophilized, For solutionIntravenous	Northstar Rx LLC	72603-160	72603-0160-06
Tobramycin	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	Belcher Pharmaceuticals, LLC	62250-110	62250-0110-01
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

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
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin	Tobramycin 3 mg/mL	SolutionOphthalmic	Proficient Rx LP	63187-973