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 |
|---|---|---|---|---|---|---|
| BMNP Nat Phos | NATRUM PHOSPHORICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5a581272-69f3-fd52-e063-6394a90a1de4 | 2026-08-31 | Warnings | 70WT22SF4B |
| Rohto Max Strength | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | e4b49550-1ca3-4bd7-854d-409b53fa5e26 | 2026-08-20 | Warnings | 6OZP39ZG8H |
| CALMS FORTE | AVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWER | Hyland's Inc. | 63ce9942-a299-4d9b-b63b-35b297472dc9 | 2026-08-13 | Warnings | 70WT22SF4B |
| Bioplasma | SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE | Hyland's Inc. | dd0a7ed2-d112-4b96-e053-2995a90ac6b6 | 2026-07-30 | Warnings | 70WT22SF4B |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | 6OZP39ZG8H |
| The Cell Salt Co. Daily Blend 12 in 1 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | The Cell Salt Company LLC | 55826f59-acf4-7370-e063-6394a90afed7 | 2026-07-01 | Warnings | 70WT22SF4B |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fd8a72-0527-df0c-e063-6294a90abe75 | 2026-06-24 | 593YOG76RN | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fddca1-b40c-7af0-e063-6294a90a410e | 2026-06-24 | 593YOG76RN | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fdf83e-f641-1f69-e063-6394a90ab750 | 2026-06-24 | 593YOG76RN | |
| Rohto Cool Relief | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30 | 2026-06-19 | Warnings | 6OZP39ZG8H |
| BM BIO24 ICING SUGAR | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b2bf9-74e8-297f-e063-6394a90a3dac | 2026-06-15 | Warnings | 70WT22SF4B |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | 70WT22SF4B |
| BM BM213 | CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOX | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 54396b10-a115-5b4f-e063-6394a90a5241 | 2026-06-14 | Warnings | 70WT22SF4B |
| BM BM38 DROPS | BERB AQUI, GRAPHITE, HYDROCOTYLE, KALI BROM, KALI IODAT, NATRUM PHOS, SULPHUR IODAT | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5410af95-519a-f0d5-e063-6294a90ac0cf | 2026-06-12 | Warnings | 70WT22SF4B |
| BM BM38 DROPS | BERB AQUI, GRAPHITE, HYDROCOTYLE, KALI BROM, KALI IODAT, NATRUM PHOS, SULPHUR IODAT | BM Private Limited | 53f8163d-28c3-b3b3-e063-6394a90a86da | 2026-06-11 | Warnings | 70WT22SF4B |
| Jacksons Cell Salts DIGESTIVE BALANCE | NAT MUR, NAT PHOS, NAT SULPH | Zettl Health Inc. | 54018d0e-372f-8afc-e063-6394a90aeb15 | 2026-06-11 | Warnings | 70WT22SF4B |
| Jacksons Cell Salts 5 IN 1 PHOS | CALC PHOS, FERRUM PHOS , KALI PHOS, MAG PHOS, NAT PHOS | Zettl Health Inc. | 53e85f92-5863-82f1-e063-6394a90af52e | 2026-06-10 | Warnings | 70WT22SF4B |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | 70WT22SF4B |
| BM BIO24 | CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d5058d-861a-9e20-e063-6294a90a164c | 2026-06-09 | Warnings | 70WT22SF4B |
| BM Nat Phos | NATRUM PHOSPHORICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53bacdaf-d7c8-9ae9-e063-6294a90a898c | 2026-06-08 | Warnings | 70WT22SF4B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.