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 |
|---|---|---|---|---|---|---|
| Rohto Max Strength | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | e4b49550-1ca3-4bd7-854d-409b53fa5e26 | 2026-08-20 | Warnings | 6OZP39ZG8H |
| TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE | B. Braun Medical Inc. | cb6d23ff-3ec5-445a-acbe-f88fd57949bf | 2026-08-19 | Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| Metabatone | ARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), 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, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM, | Energique, Inc. | 9510bb76-b717-407d-b9e8-da7743e4cfc8 | 2026-07-31 | Warnings | 4QD397987E |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | 6OZP39ZG8H |
| Rohto Cool Relief | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30 | 2026-06-19 | Warnings | 6OZP39ZG8H |
| Plenamine | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE | B. Braun Medical Inc. | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | 2026-05-08 | Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| AKSO N2 Youth Complex Essence | ARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, DIOSCOREA VILLOSA, TYROSINE | HEALWAY | 5028304b-22b4-c191-e063-6394a90a5525 | 2026-04-23 | Warnings | TE7660XO1C |
| Mannitol | MANNITOL | Hospira, Inc. | 8ad3145e-00e7-4412-b9a5-06f00f264f30 | 2026-04-21 | Warnings, Adverse reactions | 3OWL53L36A |
| Refresh Optive Mega-3 PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | 326cb5d6-c784-404f-9a13-6d69262dda6e | 2026-03-01 | Warnings | 6OZP39ZG8H |
| L-Histidine High 7410 | L-HISTIDINE HIGH | Professional Complementary Health Formulas | 7eec7d23-236f-4770-9587-1bf602fd91c2 | 2026-01-08 | Warnings | 4QD397987E |
| 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 |
| Mannitol | MANNITOL | ProPharma Distribution | 430669d7-9ad1-9a04-e063-6394a90ababb | 2025-11-07 | Warnings, Adverse reactions | 3OWL53L36A |
| Aminosyn II | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE | ICU Medical Inc. | 5b426208-f090-4650-86c3-89040ba45c2d | 2025-11-02 | Boxed warning, Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| 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 |
| Glycine | GLYCINE | ICU Medical Inc. | c10a4657-cf64-4a71-a247-363dd58993bc | 2025-10-21 | Warnings, Adverse reactions | TE7660XO1C |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 2d212e10-7e08-4aeb-b63f-dcc927897769 | 2025-10-17 | Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| Aminosyn-PF | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE | ICU Medical Inc. | 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
| Perikabiven | 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 | c2eb5522-8572-45f4-869d-42f9fd251bb6 | 2025-09-15 | Warnings, Adverse reactions | 4QD397987E TE7660XO1C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.