XENPOZYME
- Product NDC
- 58468-0050
- 11-digit product format
- 584680050
- Labeler code
- 58468
- Product ID
- 58468-0050_ce8d4153-ce95-43c4-9672-e1e951ebcdaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olipudase alfa-rpcp
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Genzyme Corporation
- Application
- BLA761261
- Marketing category
- BLA
- Marketing start
- 2022-08-29
- Substance
- OLIPUDASE ALFA
- Active strength
- 20 mg/5.1mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XENPOZYME
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLIPUDASE ALFA | 20 mg/5.1mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6D5766Q4OP |
| Rxcui | 2610411, 2610416, 2634357, 2634359 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0050-1 | XENPOZYME | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 10 |
| 58468-0050-1 | XENPOZYME | 5.1 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5.1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-0050 | XENPOZYME (OLIPUDASE ALFA-RPCP) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250306_01a910ee-a33e-4be3-ac41-322d64c34311.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 |
|---|
| 58468-0050-1 | 58468005001 | 1 VIAL in 1 CARTON (58468-0050-1) / 5.1 mL in 1 VIAL | 1 vial | 2022-08-29 | 0000-00-00 | No | No | Current |