Voraxaze
- Product NDC
- 50633-210
- 11-digit product format
- 506330210
- Labeler code
- 50633
- Product ID
- 50633-210_27e39e9a-42e0-fb03-e063-6394a90aae3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glucarpidase
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BTG International Inc.
- Application
- BLA125327
- Marketing category
- BLA
- Marketing start
- 2012-04-01
- Substance
- GLUCARPIDASE
- Active strength
- 1000 [USP'U]/1
- Pharmacologic classes
- Carboxypeptidase [EPC], Carboxypeptidases [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Voraxaze
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLUCARPIDASE | 1000 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2GFP9BJD79 |
| Rxcui | 1242131, 1242136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50633-210-11 | Voraxaze | 1 in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 1 | | 10 |
| 50633-210-11 | Voraxaze | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLUCARPIDASE | ACTIVE INGREDIENT | 2GFP9BJD79 | VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 5 | |
| GLUCARPIDASE | ACTIVE MOIETY | 2GFP9BJD79 | VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 5 | |
| TROMETHAMINE HYDROCHLORIDE | INACTIVE INGREDIENT | 383V75M34E | VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 5 | |
| ZINC ACETATE | INACTIVE INGREDIENT | FM5526K07A | VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50633-210 | VORAXAZE (GLUCARPIDASE) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241128_acaef5a6-b740-40e3-8ffe-74a75c74745c.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 |
|---|
| 50633-210-11 | 50633021011 | 1 VIAL in 1 CARTON (50633-210-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 1 vial | 2012-04-01 | 0000-00-00 | No | No | Current |