Prescription drug · BLA
Activase (Alteplase) NDC 50242-085
Kit · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-085-27 | 50242008527 | 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE-USEMarketed from Nov 13, 1987 |
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)
- Activase
- Generic name (nonproprietary)
- alteplase
- Dosage form
- Kit
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103172
- Marketing start
- Listing expires
- Identifiers
- Product ID 50242-085_48ed2eb6-728a-41d8-b024-6b34e75dc4dcSPL ID 48ed2eb6-728a-41d8-b024-6b34e75dc4dcSPL set ID c669f77c-fa48-478b-a14b-80b20a0139c2RxCUI 1804799, 1804802, 1804804, 1804806
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
N450242008527followed by a unit qualifier and the quantityPackage 50242-0085-27. 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)
Activase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS). ( 1.1 ) Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure. ( 1.2 ) Limitation of Use in AMI: the risk of stroke may be greater than the benefit in patients at low risk of death from cardiac causes. ( 1.2 ) Acute Massive Pulmonary Embolism (PE) for lysis. ( 1.3 ) 1.1 Acute Ischemic Stroke Activase is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment [see Contraindications (4.1) ] . Initiate treatment as soon as possible but within 3 …
Excerpt only. Read the full label for complete information.
About NDC 50242-085
- What is NDC 50242-085?
- 50242-085 is the product NDC for Activase (alteplase) 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?
- Activase (Alteplase).
- 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 Activase?
- 1 other product NDC are listed under this name. See all Activase NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Activase products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Activasealteplase | — | Kit | Genentech, Inc. | 50242-044 | 50242-0044-13 |
Other NDCs under BLA 103172
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 |
|---|---|---|---|---|
| Activasealteplase | — | Kit | Genentech, Inc. | 50242-044 |
| Cathflo Activasealteplase | Alteplase 2.2 mg/2mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genentech, Inc. | 50242-041 |