NDC 58468-0426-01 - Nexviazyme
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
- 58468-0426
- Requested NDC
- 58468-0426-01
- Package NDCs from labels
- 58468-0426-1, 58468-0426-01
- Manufacturer
- Genzyme Corporation | Genzyme Flanders | Genzyme Ireland Limited | Eurofins Biopharma Product Testing Ireland Limited
- Effective date
- 2025-06-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Nexviazyme | Genzyme Corporation | Genzyme Flanders | Genzyme Ireland Limited | Eurofins Biopharma Product Testing Ireland Limited | 2025-06-05 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58468-0426-1 | Nexviazyme | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | 4 | |
| 58468-0426-1 | Nexviazyme | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58468-0426 | NEXVIAZYME NGPT (AVALGLUCOSIDASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230927_80eb3c9c-01d3-44fe-90ef-81df101b954d.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58468-0426-1 | EA - Each | 58468-0426 | cac1d58e-0fd0-432b-b356-8fe8eb56264d | 1 | 2021-09-07 |
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 |
|---|---|---|---|---|---|---|
| Kabiven | DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE | Fresenius Kabi USA, LLC | afeb4837-a759-4484-a76e-e04611c459e7 | 2025-09-11 | Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| Nexviazyme | AVALGLUCOSIDASE ALFA-NGPT | Genzyme Corporation | 80eb3c9c-01d3-44fe-90ef-81df101b954d | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | BLA761194 58468-0426-1 58468-0426 58468042601 2565823 2565818 583725c8-1d65-4479-b93b-b945bfe8a39b 80eb3c9c-01d3-44fe-90ef-81df101b954d EO144CP0X9 |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| N-16 | MGO ENERGIZER | DNA Labs, Inc. | 8292b900-86c1-47ea-81da-b587439c7664 | 2025-01-09 | Warnings | TE7660XO1C |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
| Metab | CALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A, | Nutritional Specialties, Inc. | bbed9973-238f-47c5-9a50-ac0869a7eb3a | 2023-10-09 | Warnings | 4QD397987E TE7660XO1C |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
| Vital Skin Hair Nails | L-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALIS | Liddell Laboratories, Inc. | 3e8a9233-6e65-4023-b3f8-8bca369a9c2a | 2023-06-15 | Warnings | 4QD397987E |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | 3OWL53L36A |
| HGH COMPLEX | ARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, LYSINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, TRIBULUS TERRESTRIS, TYROSINE, CDP-CHOLINE, GABA | ProBlen | 2b7ee28f-474e-414b-bf74-8b2baf382947 | 2022-11-30 | Warnings | TE7660XO1C |
| Refresh Digital PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | 97e83e68-6374-4df4-93f6-d707fc32748d | 2022-11-28 | Warnings | 6OZP39ZG8H |
| Refresh Digital | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81 | 2022-11-28 | Warnings | 6OZP39ZG8H |
| 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 |
| Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Company | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 2022-08-04 | Boxed warning, Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | 6OZP39ZG8H |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| CLINIMIX | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE | Baxter Healthcare Corporation | dccff103-8695-400c-a15d-cc2fd078760a | 2021-04-13 | Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| Glycine | GLYCINE | B. Braun Medical Inc. | f4d83550-42de-44c7-b8d5-1d0debc6aec2 | 2021-04-01 | Warnings, Adverse reactions | TE7660XO1C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.