Tobramycin NDC 67457-473

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-473Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0473Add 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
67457-473-22	67457047322	25 VIAL in 1 CARTON (67457-473-22) / 2 mL in 1 VIAL (67457-473-00)Marketed from Aug 19, 2014

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 — 40 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Mylan Institutional LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065407
Marketing start: Aug 19, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 67457-473_271feb8b-14b0-4818-b877-6e8df61b57b3SPL ID 271feb8b-14b0-4818-b877-6e8df61b57b3SPL set ID ac8134d9-a726-4508-b8b9-a536ef17243dRxCUI 597823UNII HJT0RXD7JKUPC 0367457473222, 0367457428307
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

N467457047322 followed by a unit qualifier and the quantity

Package 67457-0473-22. 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 31, 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 inf…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065407

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

FDA NDC Directory listings under ANDA 065407
Product	Strength	Form · route	Labeler	Product NDC
Tobramycin	Tobramycin sulfate 40 mg/mL	InjectionIntramuscular, Intravenous	Mylan Institutional LLC	67457-428