PROLASTIN-C
- Product NDC
- 13533-700
- 11-digit product format
- 135330700
- Labeler code
- 13533
- Product ID
- 13533-700_6a2d2b1f-c8f1-4002-ba1e-925179974d95
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
- Dosage form
- KIT
- Labeler
- GRIFOLS USA, LLC
- Application
- BLA103174
- Marketing category
- BLA
- Marketing start
- 1987-12-02
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROLASTIN-C
- Listing expiration
- 2026-12-31
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13533-700-02 | PROLASTIN-C | 1 in 1 CARTON | KIT | 1 | | 25 |
| 13533-702-11 | PROLASTIN-C | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 mL | 1000 mg in 20mL | 25 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13533-700 | PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Current NDC, Legacy NDC, 2 package rows | 20220308_91edab72-c889-470e-8315-1798b5548dca.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 |
|---|
| 13533-700-02 | 13533070002 | 1 KIT in 1 CARTON (13533-700-02) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-000-06) | 1 kit | 1987-12-02 | 0000-00-00 | No | No | Current |
| 13533-702-11 | 13533070211 | 20 mL in 1 VIAL, SINGLE-DOSE | 20 ml | | | | | Historical |