Tobramycin NDC 68083-253

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0253Add 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
68083-253-25	68083025325	25 VIAL, MULTI-DOSE in 1 CARTON (68083-253-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-253-01)Marketed from Feb 11, 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 — 10 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209621
Marketing start: Feb 11, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 68083-253_5af7f80d-4d6d-404f-9ff7-1a8315625d8bSPL ID 5af7f80d-4d6d-404f-9ff7-1a8315625d8bSPL set ID 645d34d9-275d-428e-863d-ae15ad009c44RxCUI 313416, 597823UNII HJT0RXD7JK
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

N468083025325 followed by a unit qualifier and the quantity

Package 68083-0253-25. 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 Mar 9, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tobramycin injection 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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209621

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

FDA NDC Directory listings under ANDA 209621
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin	Tobramycin sulfate 40 mg/mL	InjectionIntramuscular, Intravenous	Gland Pharma Limited	68083-254