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 |
|---|---|---|---|---|---|---|
| Refresh Digital | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81 | 2022-11-28 | Warnings | 6OZP39ZG8H |
| Natrum Phosphoricum | NATRUM PHOSPHORICUM | Hahnemann Laboratories, INC. | ed01509a-afb6-476f-e053-2995a90a5aa6 | 2022-11-08 | 70WT22SF4B | |
| Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION | Fenwal, Inc. | d55cb701-9664-4931-8754-1a8cae68da06 | 2022-11-01 | 593YOG76RN | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTION | Fenwal, Inc. | f9d7f1b4-7a77-44f9-8924-10b16008b49d | 2022-11-01 | 593YOG76RN | |
| Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) | Fenwal, Inc. | 4a08a9ec-46a5-4fcf-80ee-5c33f1a8b746 | 2022-11-01 | 593YOG76RN | |
| Dr Talbots Infgant Gas Colic Relief | CARBO VEGETABILIS 12X,CHAMOMILLA 12X,FOENICULUM VULGARE 12X,LYCOPODIUM 30X,NUX MOSCHATA 12X,RAPHANUS SATIVUS 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6X | Talbot's Pharmaceuticals Family Products,LLC. | e8bee190-04b2-4be6-e053-2a95a90a30a0 | 2022-09-28 | Warnings | 70WT22SF4B |
| Dr Talbots Infant Tummy Ache Relief | CALENDULA OFFICINALIS 12X,CARBO VEGETABILIS 12X,LYCOPODIUM 30X,FOENICULUM VULGARE 12X,NUX MOSCHATA 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6X | Talbot's Pharmaceuticals Family Products,LLC. | e9c24994-b935-36e6-e053-2a95a90a78df | 2022-09-28 | Warnings | 70WT22SF4B |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | ebd0839e-2e1d-4e0e-986c-19f1f5c76358 | 2022-09-15 | Warnings | 6OZP39ZG8H |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80 | Allergan, Inc. | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 2022-09-01 | Warnings | 6OZP39ZG8H |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | 6OZP39ZG8H |
| Sodium Phosphates | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | Fresenius Kabi USA, LLC | 5bf47be3-f3fe-452b-8113-941796498345 | 2022-03-31 | Warnings, Adverse reactions | 593YOG76RN |
| Lyme Disease Support 1 | ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA. | OHM PHARMA INC. | 035e75d6-aeef-4dfd-b076-9d3d8e4a5086 | 2021-12-29 | Warnings | 70WT22SF4B |
| OHM Tonic Syrup | ALFALFA, ARALIA QUIN (GINSENG), AVENA, CALC PHOS, CINCHONA, FERRUM PHOS, HYDRASTIS, KALI IOD, KALI MUR, KALI PHOS, MAG PHOS, NAT PHOS, NUX VOM, PHOSPHORICUM AC. | OHM PHARMA INC. | f3aca2b2-8df2-4995-91fd-c81c3286a0f8 | 2021-12-29 | Warnings | 70WT22SF4B |
| TH-101 | CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROB | Temple Health Nutrition, LLC | d54bb860-560c-4f8f-9aea-a0b7774cc92b | 2021-12-29 | Warnings | 70WT22SF4B |
| GUNA STOMACH PLUS | ANTIMONIUM CRUDUM - ARGENTUM NITRICUM - ARSENICUM ALBUM - IPECACUANHA - NUX VOMICA - ORIGANUM MAJORANA - CUPRUM METALLICUM - TARAXACUM OFFICINALE - NATRUM PHOSPHORICUM - | Guna spa | ba495fce-b7ad-af83-e053-2a95a90a388a | 2021-12-15 | Warnings | 70WT22SF4B |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | d763511e-f1a7-4014-94b9-f7ad8f023ff4 | 2021-12-02 | 593YOG76RN | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | cf9f43a0-c750-4cf0-ac49-176ab2105aab | 2021-12-02 | 593YOG76RN | |
| InterSol | PLATELET ADDITIVE 3 | Fenwal, Inc. | e4f06c0b-7cb1-49c9-97a4-2cfc21298495 | 2021-11-16 | Warnings, Adverse reactions | 593YOG76RN |
| Dr. Talbots Gas Colic Relief | CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, RAPHANUS SATIVUS, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM | Talbot's Pharmaceuticals Family Products, LLC | 91213655-92d2-64c2-e053-2995a90aaa5a | 2021-10-05 | Warnings | 70WT22SF4B |
| Dr. Talbots Tummy Ache Relief | CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM | Talbot's Pharmaceuticals Family Products, LLC | 91c1e0ae-9999-0ae2-e053-2995a90a2d71 | 2021-10-05 | Warnings | 70WT22SF4B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.