TNKase
- Product NDC
- 50242-014
- 11-digit product format
- 502420014
- Labeler code
- 50242
- Product ID
- 50242-014_d87d7f04-a851-4187-846d-527dd4bbab6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tenecteplase
- Dosage form
- KIT
- Labeler
- Genentech, Inc.
- Application
- BLA103909
- Marketing category
- BLA
- Marketing start
- 2025-02-28
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TNKase
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 284422, 313212, 2711697, 2711699 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-009-01 | TNKase | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | | 25 mg in 5mL | 4 |
| 50242-009-01 | TNKase | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 25 mg in 5mL | 4 |
| 50242-014-03 | TNKase | 1 in 1 CARTON | KIT | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-014 | TNKASE (TENECTEPLASE) KIT [GENENTECH, INC.] | 3 | Current NDC, 3 package rows | 20250412_e647640d-c395-4b4b-a0be-1162f9c21d84.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-009-01 | 50242000901 | 1 in 1 CARTON | | | | | Historical |
| 50242-014-03 | 50242001403 | 1 KIT in 1 CARTON (50242-014-03) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-009-01) / 5 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-907-01) / 5.2 mL in 1 VIAL, SINGLE-USE | 1 kit | 2025-02-28 | No | No | Historical |