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 |
|---|---|---|---|---|---|---|
| Scrofularoforce | RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA | BioActive Nutritional, Inc. | 737cd410-0405-41b0-b7f2-29bb20037849 | 2026-06-08 | Warnings | 70WT22SF4B |
| BM Nat Phos Icing Sugar | NATRUM PHOSPHORICUM ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5356e3a2-11f9-98e5-e063-6294a90a08eb | 2026-06-03 | Warnings | 70WT22SF4B |
| BM NAT PHOS POTENCY | NAT PHOS | BM Private Limited | 53239eb6-1403-619c-e063-6394a90a4958 | 2026-05-31 | Warnings | 70WT22SF4B |
| BM BM213 | CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOX | BM Private Limited | 52cca143-b5cd-e1d9-e063-6394a90a5b15 | 2026-05-27 | Warnings | 70WT22SF4B |
| Sodium Phosphates | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | Hospira, Inc. | 6f044d16-295e-43ff-72a3-b045c387bc5c | 2026-05-11 | Warnings, Adverse reactions | 593YOG76RN |
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | 3OWL53L36A |
| Quantum Resonance | ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM | Deseret Biologicals, Inc. | f94a10bd-1c40-42c7-b458-b58070614549 | 2026-04-10 | Warnings | 70WT22SF4B |
| Quantum Resonance | ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM | Deseret Biologicals, Inc. | 1467111a-bef6-473d-b7f2-3309a9bb72ce | 2026-04-10 | Warnings | 70WT22SF4B |
| Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate | DIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATE | Rising Pharma Holdings, Inc. | b01eac95-dbe3-4b21-a922-187e0fc8ad23 | 2026-04-07 | Adverse reactions | 593YOG76RN |
| Buffer pH | CHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIA | NaturalCare | 2161a2e2-613d-4dac-a5f6-796d40e849d9 | 2026-03-25 | Warnings | 70WT22SF4B |
| PHOSPHA 250 NEUTRAL | DIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATE | Rising Pharma Holdings, Inc. | 9432adfc-6add-4ab4-ae93-2e2daf348be2 | 2026-03-25 | Adverse reactions | 593YOG76RN |
| BM BIO7 | CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULF. | BM Private Limited | 4d260c2a-9218-17d0-e063-6394a90a62b7 | 2026-03-16 | Warnings | 70WT22SF4B |
| BM BIO24 | CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS. | BM Private Limited | 4d277580-9a76-ae86-e063-6394a90a20e9 | 2026-03-16 | Warnings | 70WT22SF4B |
| BM BIO24 ICING SUGAR | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS | BM Private Limited | 4d2948fd-ac6b-f43f-e063-6394a90a747d | 2026-03-16 | Warnings | 70WT22SF4B |
| Drop20 | FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE) | Pick Enterprises Corp | baa96813-dc95-472e-a834-880a0cd484a7 | 2026-03-13 | Warnings | 70WT22SF4B |
| Appetrol 20 | FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE) | Carbalor LLC | d66234a3-2477-42be-8f7b-283e3a5f87ed | 2026-03-12 | Warnings | 70WT22SF4B |
| SODIUM PHOSPHATES | SODIUM PHOSPHATES | GLENMARK PHARMACEUTICALS INC., USA | c968f70b-a670-4aef-a7e0-89468ad62d9c | 2026-03-12 | Warnings, Adverse reactions | 70WT22SF4B 593YOG76RN |
| SODIUM PHOSPHATES | SODIUM PHOSPHATES | Caplin Steriles Limited | 46de992b-5fc8-4dad-8d95-77938decb67e | 2026-03-10 | Warnings, Adverse reactions | 70WT22SF4B 593YOG76RN |
| Refresh Optive Mega-3 PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | 326cb5d6-c784-404f-9a13-6d69262dda6e | 2026-03-01 | Warnings | 6OZP39ZG8H |
| BM BIO28 (General Tonic) | 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 | 38d2cff0-3550-b119-e063-6394a90a31cb | 2026-02-23 | Warnings | 70WT22SF4B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.