Prescription drug · ANDA
Tigecycline NDC 55150-228
Tigecycline 50 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-228-10 | 5515002281055150022810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jun 11, 2019 |
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)
- Tigecycline
- Generic name (nonproprietary)
- tigecycline
- Active ingredients
- Tigecycline — 50 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206335
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 55150-228_a5262444-a326-478c-a6d6-b515ef3d1219SPL ID a5262444-a326-478c-a6d6-b515ef3d1219SPL set ID dd58e0c3-d8a8-4cf2-96f8-9dd08f309579RxCUI 581531UNII 70JE2N95KRUPC 0355150228102
- Pharmacologic class
- Tetracycline-class 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
N455150022810followed by a unit qualifier and the quantityPackage 55150-0228-10. 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)
Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections (1.1) Complicated intra-abdominal infections (1.2) Community-acquired bacterial pneumonia (1.3) Limitations of Use : Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia (1.4) . To reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline and other antibacterial drugs, tigecycline should be used only to treat infections that are proven or strongly suspected to be caused by bacteria (1.5). 1…
Excerpt only. Read the full label for complete information.
About NDC 55150-228
- What is NDC 55150-228?
- 55150-228 is the product NDC for Tigecycline, Tigecycline 50 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tigecycline.
- What is the active ingredient?
- Tigecycline.
- Who is the labeler?
- Eugia US LLC, NDC labeler code 55150. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tigecycline?
- 4 other product NDCs are listed under this name. See all Tigecycline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tigecycline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tigecycline | Tigecycline 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-019 | 71288-0019-11 |
| Tigecycline | Tigecycline 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Apotex Corp | 60505-6098 | 60505-6098-01 |
| Tigecycline | Tigecycline 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Amneal Pharmaceuticals LLC | 70121-1647 | 70121-1647-07 |
| Tigecycline | Tigecycline 50 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous, Parenteral | Sandoz Inc | 0781-3481 | 00781-3481-92 |