VARIZIG
- Product NDC
- 49591-126
- 11-digit product format
- 495910126
- Labeler code
- 49591
- Product ID
- 49591-126_4a7d4637-7885-f3f6-e063-6394a90ae60c
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Kamada Ltd.
- Application
- BLA125430
- Marketing category
- BLA
- Marketing start
- 2024-03-01
- Substance
- HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN
- Active strength
- 125 [iU]/1.2mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VARIZIG
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN | 125 [iU]/1.2mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49591-126-11 | VARIZIG | 1.2 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1.2 | | 5 |
| 49591-126-51 | VARIZIG | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49591-126 | VARIZIG (HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN) INJECTION, SOLUTION [KAMADA LTD.] | 4 | Current NDC, 2 package rows | 20240301_f367f996-aafa-4b8b-8cb4-63a009cd2015.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 49591-126-11 | 49591012611 | 1.2 mL in 1 VIAL, GLASS | 1.2 ml | | | | Historical |
| 49591-126-51 | 49591012651 | 1 VIAL, GLASS in 1 CARTON (49591-126-51) / 1.2 mL in 1 VIAL, GLASS (49591-126-11) | | 2024-03-01 | No | No | Historical |