Zemaira
- Product NDC
- 0053-7201
- 11-digit product format
- 000537201
- Labeler code
- 0053
- Product ID
- 0053-7201_a60040d6-46ed-4a3b-af7e-528a65b7fca7
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- alpha-1-proteinase inhibitor human
- Dosage form
- KIT
- Labeler
- CSL Behring LLC
- Application
- BLA125078
- Marketing category
- BLA
- Marketing start
- 2003-07-08
- 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 |
|---|
| 0053-7201-02 | Zemaira | 1 in 1 CARTON | KIT | 1 | | 27 |
| 0053-7211-01 | Zemaira | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 1000 mg in 20mL | 27 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0053-7201 | ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT ZEMAIRA (.ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC] | 27 | Current NDC, Legacy NDC, 2 package rows | 20240926_0c3354b5-a1d8-4f98-ad55-2eafe4265c4e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0053-7201-02 | 00053720102 | 1 KIT in 1 CARTON (0053-7201-02) * 20 mL in 1 VIAL, SINGLE-DOSE (0053-7211-01) * 20 mL in 1 VIAL, SINGLE-DOSE (0053-7653-20) | 1 kit | 2003-07-08 | 0000-00-00 | No | No | Current |
| 0053-7211-01 | 00053721101 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | | Historical |