NDC 58468-0160-01 - Lumizyme
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 58468-0160
- Requested NDC
- 58468-0160-01
- Package NDCs from labels
- 58468-0160-1, 58468-0160-2, 58468-0160-01
- Manufacturer
- Genzyme Corporation | Genzyme Flanders | Genzyme Ireland Limited | Eurofins Biopharma Product Testing Ireland Limited
- Effective date
- 2025-01-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Lumizyme | Genzyme Corporation | Genzyme Flanders | Genzyme Ireland Limited | Eurofins Biopharma Product Testing Ireland Limited | 2025-01-10 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| 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 Dashboard NDC Coverage#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58468-0160-1 | EA - Each | 58468-0160 | 0669f375-6a12-4b35-b24c-06dbe9d77cd1 | 1 | 2012-07-24 |
| 58468-0160-2 | EA - Each | 58468-0160 | e2f69a41-9a95-4663-86fb-415cdb1ca753 | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
| 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 985a3341-0fe0-1dd6-e053-2a95a90ad2c5 | 2025-07-25 | Warnings | 70WT22SF4B |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1b4e96-c96f-6424-e053-2991aa0aef30 | 2025-07-24 | Warnings | 70WT22SF4B |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1a9ef9-9a54-5f94-e053-2a91aa0ab477 | 2025-07-24 | Warnings | 70WT22SF4B |
| Nat Phos 6X | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | Hyland's Inc. | dc7c259e-4bcc-c3d9-e053-2a95a90a0c01 | 2025-07-09 | Warnings | 70WT22SF4B |
| Parasode | ARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | Zorex | 0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec | 2025-07-01 | Warnings | 70WT22SF4B |
| InterSol | PLATELET ADDITIVE 3 | Fenwal, Inc. | 17dec820-1b57-4ac9-82a8-419cab664a2f | 2025-06-27 | Warnings, Adverse reactions | 593YOG76RN |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| Bestmade Natural Products Nat Phos 8x | NATRUM PHOSPHORICUM | Bestmade Natural Products | 31e10f2d-1aa7-feb8-e063-6394a90a088a | 2025-04-03 | Warnings | 70WT22SF4B |
| Bestmade Natural Products Nat Phos | NAT PHOS | Bestmade Natural Products | e9e9d45d-bbb3-5f74-e053-2995a90adec3 | 2025-03-21 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO24 Lactose Free | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS | Bestmade Natural Products | 303a81d7-5f4e-e754-e063-6394a90a751f | 2025-03-13 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO25 Lactose Free | NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 303acd47-e033-1563-e063-6394a90ae38e | 2025-03-13 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO28 Lactose Free | CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 303b4d92-9f75-38a5-e063-6294a90ae93d | 2025-03-13 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO7 Lactose Free | CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULPH | Bestmade Natural Products | 3022c9be-81b2-6362-e063-6294a90abf15 | 2025-03-12 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO24 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS | Bestmade Natural Products | 300e1e77-f1dc-03fa-e063-6294a90a106e | 2025-03-11 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO25 | NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 300e3d46-1fc3-659e-e063-6394a90ade25 | 2025-03-11 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO28 | CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | Bestmade Natural Products | 300ead4c-6937-d597-e063-6394a90ad6bb | 2025-03-11 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO7 | CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULPH | Bestmade Natural Products | 2ffdc916-b94f-774e-e063-6294a90a9cc8 | 2025-03-10 | Warnings | 70WT22SF4B |
| Bestmade Natural Products Nat Phos | NATRUM PHOSPHORICUM | Bestmade Natural Products | 2faa1f81-98d7-5cbf-e063-6394a90a33c9 | 2025-03-06 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BM213 | GRAPHITES, RHUS TOX, NATRUM SULPH, CARBO VEG, NAT PHOS | Bestmade Natural Products | 2f6d9587-7185-7fef-e063-6394a90aa6fd | 2025-03-03 | Warnings | 70WT22SF4B |
| MB CAPS | METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE | Allegis Pharmaceuticals, LLC | 2efeb281-b84b-4750-e063-6394a90a27ee | 2025-02-25 | Warnings, Adverse reactions | 593YOG76RN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.