Lumizyme
- Product NDC
- 58468-0160
- 11-digit product format
- 584680160
- Labeler code
- 58468
- Product ID
- 58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALGLUCOSIDASE ALFA
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Genzyme Corporation
- Application
- BLA125291
- Marketing category
- BLA
- Marketing start
- 2010-05-24
- Substance
- ALGLUCOSIDASE ALFA
- Active strength
- 5 mg/mL
- 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
- Lumizyme
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALGLUCOSIDASE ALFA | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DTI67O9503 |
| Rxcui | 629568, 993072 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0160-1 | Lumizyme | 10.5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, FOR SOLUTION | 10.5 | | 21 |
| 58468-0160-1 | Lumizyme | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 21 |
| 58468-0160-2 | Lumizyme | 10 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 10 | | 21 |
| 58468-0160-2 | Lumizyme | 10.5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, FOR SOLUTION | 10.5 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALGLUCOSIDASE ALFA | ACTIVE INGREDIENT | DTI67O9503 | LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] | 8 | |
| ALGLUCOSIDASE ALFA | ACTIVE MOIETY | DTI67O9503 | LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] | 8 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] | 8 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] | 8 | |
| SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | INACTIVE INGREDIENT | 70WT22SF4B | LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] | 8 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-0160 | LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION] | 21 | Current NDC, Legacy NDC, 4 package rows | 20250112_d6bfbc45-2d34-439e-8aad-59ee2d53d4df.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 |
|---|
| 58468-0160-1 | 58468016001 | 1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USE | 2010-05-24 | 0000-00-00 | No | No | Current |
| 58468-0160-2 | 58468016002 | 10 VIAL, SINGLE-USE in 1 CARTON (58468-0160-2) > 10.5 mL in 1 VIAL, SINGLE-USE | 2010-05-24 | 2023-08-31 | No | No | Current |