Prescription drug · ANDA
Tobramycin NDC 70700-173
Tobramycin sulfate 1.2 g/30mL · Injection, Powder, Lyophilized, For solution · Intravenous · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-173-22 | 7070001732270700017322 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-173-22) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Jul 12, 2021 | |
| 70700-173-86 | 7070001738670700017386 | 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-173-86) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Jan 20, 2023 |
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
- Xiromed LLCNDC labeler code 70700
- 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 70700-173_4b807769-4cf0-f110-e063-6294a90ac6a7SPL ID 4b807769-4cf0-f110-e063-6294a90ac6a7SPL set ID 8b50d1b5-ea8a-5844-358a-493f1965c07fRxCUI 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.
- NDC on a medical claim
N470700017322followed by a unit qualifier and the quantityPackage 70700-0173-22. 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 . 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.
About NDC 70700-173
- What is NDC 70700-173?
- 70700-173 is the product NDC for Tobramycin, Tobramycin sulfate 1.2 g/30mL injection, powder, lyophilized, for solution, listed with the FDA by Xiromed LLC. It has 2 package NDCs, 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?
- Xiromed LLC, NDC labeler code 70700. 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.
Related NDCs: other Tobramycin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
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 | Fosun Pharma USA Inc | 72266-163 |
| Tobramycin | Tobramycin sulfate 1.2 g/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Northstar Rx LLC | 72603-160 |