pemgarda
- Product NDC
- 81960-031
- 11-digit product format
- 819600031
- Labeler code
- 81960
- Product ID
- 81960-031_4b1b8d43-0bf4-849a-e063-6294a90abfb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pemivibart
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Invivyd, Inc
- Application
- EUA000122
- Marketing category
- EMERGENCY USE AUTHORIZATION
- Marketing start
- 2024-03-22
- Substance
- PEMIVIBART
- Active strength
- 125 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- pemgarda
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEMIVIBART | 125 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 557S3L3FAP |
| Rxcui | 2677805, 2677811 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81960-031-03 | pemgarda | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 4 | | 10 |
| 81960-031-03 | pemgarda | 9 in 1 CARTON | INJECTION | 9 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81960-031 | PEMGARDA (PEMIVIBART) INJECTION [INVIVYD, INC] | 2 | Current NDC, 2 package rows | 20240324_0bdc20a9-791f-9a06-e063-6394a90a84cc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81960-031-03 | 81960003103 | 9 VIAL, SINGLE-DOSE in 1 CARTON (81960-031-03) / 4 mL in 1 VIAL, SINGLE-DOSE | 2024-03-22 | No | No | Historical |