Prescription drug · ANDA
Tobramycin NDC 68083-241
Tobramycin sulfate 40 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-241-01 | 68083024101 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-241-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Feb 9, 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 — 40 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209346
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 68083-241_7dec68fc-8f9a-4a26-9578-81bb22a5a1b5SPL ID 7dec68fc-8f9a-4a26-9578-81bb22a5a1b5SPL set ID 02b48684-168c-4cd9-8375-794206eff23eRxCUI 597823UNII HJT0RXD7JKUPC 0368083241018
- 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.
- NDC on a medical claim
N468083024101followed by a unit qualifier and the quantityPackage 68083-0241-01. 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 . 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.