Nexviazyme
- Product NDC
- 58468-0426
- 11-digit product format
- 584680426
- Labeler code
- 58468
- Product ID
- 58468-0426_583725c8-1d65-4479-b93b-b945bfe8a39b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- avalglucosidase alfa-ngpt
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Genzyme Corporation
- Application
- BLA761194
- Marketing category
- BLA
- Marketing start
- 2021-08-06
- Substance
- AVALGLUCOSIDASE ALFA
- Active strength
- 100 mg/10mL
- Pharmacologic classes
- Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC], alpha-Glucosidases [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nexviazyme
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVALGLUCOSIDASE ALFA | 100 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EO144CP0X9 |
| Rxcui | 2565818, 2565823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0426-1 | Nexviazyme | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
| 58468-0426-1 | Nexviazyme | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-0426 | NEXVIAZYME NGPT (AVALGLUCOSIDASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230927_80eb3c9c-01d3-44fe-90ef-81df101b954d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58468-0426-1 | 58468042601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (58468-0426-1) / 10 mL in 1 VIAL, SINGLE-DOSE | 2021-08-06 | 0000-00-00 | No | No | Current |