ZEMAIRA
- Product NDC
- 57516-110
- 11-digit product format
- 575160110
- Labeler code
- 57516
- Product ID
- 57516-110_31a53b86-857c-a2d9-e063-6394a90abfb8
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- alpha-1-proteinase inhibitor human kit
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- Fisher Clinical Services Inc.
- Application
- BLA125078
- Marketing category
- BLA
- Marketing start
- 2023-07-31
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZEMAIRA
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57516-110-02 | ZEMAIRA | 1 in 1 CARTON | KIT | 1 | | 1 |
| 57516-111-01 | ZEMAIRA | 76 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 76 mL | 4000 mg in 76mL | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57516-110 | ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN KIT) KIT [FISHER CLINICAL SERVICES INC.] | 1 | Current NDC, 2 package rows | 20250403_31a53b86-857b-a2d9-e063-6394a90abfb8.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125078 | Zemaira | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57516-110-02 | 57516011002 | 1 KIT in 1 CARTON (57516-110-02) * 76 mL in 1 VIAL, SINGLE-DOSE (57516-111-01) * 76 mL in 1 VIAL, SINGLE-DOSE (57516-112-20) | 1 kit | 2023-07-31 | No | No | Current |
| 57516-111-01 | 57516011101 | 76 mL in 1 VIAL, SINGLE-DOSE | 76 ml | | | | Historical |