Ryplazim
- Product NDC
- 70573-099
- 11-digit product format
- 705730099
- Labeler code
- 70573
- Product ID
- 70573-099_cbc275fd-d97b-4320-ba27-80752d592572
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- plasminogen
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Kedrion Biopharma, Inc.
- Application
- BLA125659
- Marketing category
- BLA
- Marketing start
- 2021-06-04
- Substance
- PLASMINOGEN
- Active strength
- 68.8 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ryplazim
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PLASMINOGEN | 68.8 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70573-099-01 | Ryplazim | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
| 70573-099-02 | Ryplazim | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70573-099 | RYPLAZIM (PLASMINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [KEDRION BIOPHARMA, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250406_5c5a00ca-d662-46e6-b9ac-a07e9cfcc0a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70573-099-01 | 70573009901 | 1 in 1 VIAL, GLASS | | | | | Historical |
| 70573-099-02 | 70573009902 | 1 VIAL, GLASS in 1 CARTON (70573-099-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70573-099-01) | 2021-06-04 | 0000-00-00 | No | No | Current |