Prescription drug · BLA
TNKase (Tenecteplase) NDC 50242-176
Kit · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-176-01 | 50242017601 | 1 KIT in 1 CARTON (50242-176-01) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Jan 5, 2024 |
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)
- TNKase
- Generic name (nonproprietary)
- tenecteplase
- Dosage form
- Kit
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103909
- Marketing start
- Listing expires
- Identifiers
- Product ID 50242-176_d87d7f04-a851-4187-846d-527dd4bbab6dSPL ID d87d7f04-a851-4187-846d-527dd4bbab6dSPL set ID e647640d-c395-4b4b-a0be-1162f9c21d84RxCUI 284422, 313212, 2711697, 2711699
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.
- NDC on a medical claim
N450242017601followed by a unit qualifier and the quantityPackage 50242-0176-01. 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 .
Indications (excerpt from the label)
TNKase is a tissue plasminogen activator (tPA) indicated: for the treatment of acute ischemic stroke (AIS) in adults. ( 1.1 ) to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. ( 1.2 ) 1.1 Acute Ischemic Stroke TNKase is indicated for the treatment of acute ischemic stroke (AIS) in adults. 1.2 Acute ST Elevation Myocardial Infarction TNKase is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.
Excerpt only. Read the full label for complete information.
About NDC 50242-176
- What is NDC 50242-176?
- 50242-176 is the product NDC for TNKase (tenecteplase) kit, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TNKase (Tenecteplase).
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TNKase?
- 2 other product NDCs are listed under this name. See all TNKase NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other TNKase products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| TNKasetenecteplase | — | Kit | Genentech, Inc. | 50242-014 | 50242-0014-03 |
| TNKasetenecteplase | — | Kit | Genentech, Inc. | 50242-120 | 50242-0120-47 |
Other NDCs under BLA 103909
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 |
|---|---|---|---|---|
| TNKasetenecteplase | — | Kit | Genentech, Inc. | 50242-014 |
| TNKasetenecteplase | — | Kit | Genentech, Inc. | 50242-120 |