Prescription drug · ANDA
Tobramycin NDC 72266-163
Tobramycin sulfate 1.2 g/30mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fosun Pharma USA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72266-163-06 | 72266016306 | 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72266-163-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (72266-163-01)Marketed from Aug 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 — 1.2 g/30mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fosun Pharma USA Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211189
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 72266-163_55a28671-9f6d-90be-e063-6294a90ac87cSPL ID 55a28671-9f6d-90be-e063-6294a90ac87cSPL set ID c4751a4f-c9c1-60c5-e053-2995a90aeba9RxCUI 597823UNII HJT0RXD7JKUPC 0372266163066
- 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
N472266016306followed by a unit qualifier and the quantityPackage 72266-0163-06. 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 . 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.
Other NDCs under ANDA 211189
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tobramycin | Tobramycin sulfate 1.2 g/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-312 |
| 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 | Northstar Rx LLC | 72603-160 |