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 Well | CALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA | JoyWell Co LLC | 592c1f48-21c8-4ff5-8818-046662c9effe | 2025-12-11 | Warnings | 70WT22SF4B |
| BM BIO28 ICING SUGAR | 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 | 3e855f3b-c73d-a153-e063-6394a90ad63a | 2025-12-02 | Warnings | 70WT22SF4B |
| Bestmade Natural Products Bio28 | 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 | 3e85a931-57f6-2a55-e063-6294a90ac180 | 2025-12-02 | Warnings | 70WT22SF4B |
| Bestmade Natural Products BIO28 | 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 | 3e46ee90-2c2c-0a70-e063-6294a90a576a | 2025-12-02 | Warnings | 70WT22SF4B |
| BM Nat Phos | NATRUM PHOSPHORICUM | BM Private Limited | 37b0db27-eede-9141-e063-6294a90a8a0c | 2025-12-02 | Warnings | 70WT22SF4B |
| BM Nat Phos Icing Sugar | NATRUM PHOSPHORICUM ICING SUGAR | BM Private Limited | 37c22e9a-375d-9018-e063-6294a90a2f56 | 2025-12-02 | Warnings | 70WT22SF4B |
| Candida HP | BAPTISIA TINCTORIA ROOT, ECHINACEA PURPUREA, GLYCYRRHIZA GLABRA, ASTRAGALUS NUTTALLII LEAF, CANDIDA ALBICANS, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, NITRIC ACID | Natural Creations, Inc. | b587a3f0-628b-41f7-8afb-2cdcd896279e | 2025-11-20 | Warnings | 70WT22SF4B |
| Fleet | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC | C.B. Fleet Company, Inc. | c1677d70-203b-493e-88f0-815a66133f1d | 2025-11-20 | Warnings | 70WT22SF4B |
| Heartburn Relief | CARBO MORE | TRP Company | 14bd30e5-a981-597a-e054-00144ff8d46c | 2025-11-17 | Warnings | 70WT22SF4B |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 8f8f53e3-fe31-e7b5-e053-2995a90a710d | 2025-11-14 | Warnings | 3OWL53L36A |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | 3OWL53L36A |
| LUMO Booz Hangover Companiion | CHININUM ARSENICOSUM, NATRUM PHOSPHORICUM, NUX VOOMICA, VESPA CRABRO | Applied Bioenergetics, LLC | 8e23e541-2c78-4ca0-a61a-ad110665c7f3 | 2025-11-10 | Warnings | 70WT22SF4B |
| Mannitol | MANNITOL | ProPharma Distribution | 430669d7-9ad1-9a04-e063-6394a90ababb | 2025-11-07 | Warnings, Adverse reactions | 3OWL53L36A |
| Ionosol MB and Dextrose | DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | ICU Medical Inc. | 1b457b1d-0e80-4578-ba6f-dedf513fc962 | 2025-10-30 | Warnings, Adverse reactions | 593YOG76RN |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | 3OWL53L36A |
| Miranda Castros Phosphorus 5 Cell Salts For Physical and Emotional Fatigue, Stress and Tension | CALCAREA PHOS, FERRUM PHOS, KALI PHOS, MAGNESIUM PHOS, NATRUM PHOS | MIRANDA CASTRO'S SHOP, LLC | 2670fdeb-0c80-9f23-e063-6394a90a8c6a | 2025-10-23 | Warnings | 70WT22SF4B |
| Me NaPhos MB Hyo 1 | URINARY ANTISEPTIC ANTISPASMODIC | Method Pharmaceuticals | 2ae628e7-3b33-6a9a-e054-00144ff8d46c | 2025-10-21 | Warnings, Adverse reactions | 593YOG76RN |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| Sodium Phosphates | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUS | Civica, Inc. | 8fd901e6-30cb-411a-b820-b9e79625ec7c | 2025-08-08 | Warnings, Adverse reactions | 593YOG76RN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.