What is NDC 68083-312?

68083-312 is the product NDC for Tobramycin, Tobramycin sulfate 1.2 g/30mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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 68083-312 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0312Add 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
68083-312-06	6808303120668083031206	6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-312-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (68083-312-01)Marketed from May 18, 2021

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 sulfate — 1.2 g/30mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211189
Marketing start: May 18, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 68083-312_a13f2109-eb69-4d3a-9203-790cb6520e78SPL ID a13f2109-eb69-4d3a-9203-790cb6520e78SPL set ID 38219f34-4859-428f-9ec1-06ead7604211RxCUI 597823UNII HJT0RXD7JKUPC 0368083312060
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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083031206 followed by a unit qualifier and the quantity

Package 68083-0312-06. 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 Oct 17, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P. aeruginosa , E. coli , and Klebsiella sp Lower respiratory tract infections caused by P. aeruginosa , Klebsiella sp, Enterobacter sp, Serratia sp, E. coli , and S. aureus (penicillinase and non-penicillinase-producing strains). Serious central-nervous-system infections (meningitis) caused by susceptible organisms. Intra-abdominal infections, including peritonitis, caused by E. coli , Klebsiella sp, and Enterobacter sp. Skin, bone, and skin structure …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-312

What is NDC 68083-312?: 68083-312 is the product NDC for Tobramycin, Tobramycin sulfate 1.2 g/30mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. 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 sulfate.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. 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/4mL	SolutionRespiratory (Inhalation)	NorthStar RxLLC	72603-630	72603-0630-56
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

All 55 Tobramycin NDCs

Other NDCs under ANDA 211189

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

FDA NDC Directory listings under ANDA 211189
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin	Tobramycin sulfate 1.2 g/30mL	Injection, Powder, Lyophilized, For solutionIntravenous	Xiromed LLC	70700-173
Tobramycin	Tobramycin sulfate 1.2 g/30mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fosun Pharma USA Inc	72266-163
Tobramycin	Tobramycin sulfate 1.2 g/30mL	Injection, Powder, Lyophilized, For solutionIntravenous	Northstar Rx LLC	72603-160