Prescription drug · ANDA
Tigecycline NDC 60505-6098
Tigecycline 50 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-6098-1 | 6050560980160505609801 | 10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Apr 9, 2019 |
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)
- Tigecycline
- Generic name (nonproprietary)
- tigecycline
- Active ingredients
- Tigecycline — 50 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Apotex CorpNDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204439
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 60505-6098_d4e75cae-c197-e995-7903-2d41c6c1371dSPL ID d4e75cae-c197-e995-7903-2d41c6c1371dSPL set ID 230484a8-408c-dcc1-d0c4-d9dd9a46831bRxCUI 581531UNII 70JE2N95KR
- 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
N460505609801followed by a unit qualifier and the quantityPackage 60505-6098-01. 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)
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 for injection and other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected…
Excerpt only. Read the full label for complete information.
About NDC 60505-6098
- What is NDC 60505-6098?
- 60505-6098 is the product NDC for Tigecycline, Tigecycline 50 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Apotex Corp. 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?
- Apotex Corp, NDC labeler code 60505. 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/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Eugia US LLC | 55150-228 | 55150-0228-10 |
| 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 |