Prescription drug · ANDA
Tobramycin NDC 39822-0412
Tobramycin sulfate 1.2 g/30mL · Injection, Powder, Lyophilized, For solution · Intravenous · XGen Pharmaceuticals DJB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39822-0412-1 | 3982204120139822041201 | 1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIALMarketed from Aug 17, 2001 | |
| 39822-0412-6 | 3982204120639822041206 | 6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIALMarketed from Aug 17, 2001 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- XGen Pharmaceuticals DJB, Inc.NDC labeler code 39822
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065013
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2SPL ID 40a90656-9bc2-494b-e063-6294a90a04f2SPL set ID a384641c-04e3-4ab5-b152-7408cd07b64dRxCUI 597823UNII HJT0RXD7JKUPC 0339822041213, 0339822041268
- 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
N439822041201followed by a unit qualifier and the quantityPackage 39822-0412-01. 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 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-str…
Excerpt only. Read the full label for complete information.
About NDC 39822-0412
- What is NDC 39822-0412?
- 39822-0412 is the product NDC for Tobramycin, Tobramycin sulfate 1.2 g/30mL injection, powder, lyophilized, for solution, listed with the FDA by XGen Pharmaceuticals DJB, Inc.. 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?
- XGen Pharmaceuticals DJB, Inc., NDC labeler code 39822. 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?
- 55 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/4mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-630 | 72603-0630-56 |
| Tobramycin | Tobramycin 300 mg/5mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-430 | 72603-0430-56 |
| Tobramycin | Tobramycin 300 mg/5mL | SolutionRespiratory (Inhalation) | American Health Packaging | 60687-731 | 60687-0731-83 |
| Tobramycin | Tobramycin sulfate 1.2 g/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Northstar Rx LLC | 72603-160 | 72603-0160-06 |
| Tobramycin | Tobramycin 3 mg/mL | Solution/ dropsOphthalmic | Belcher Pharmaceuticals, LLC | 62250-110 | 62250-0110-01 |
| 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 |