NDC 64764-515 - ADZYNMA
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
- 64764-515
- Package NDCs from labels
- 64764-515-50
- Manufacturer
- TAKEDA PHARMACEUTICALS AMERICA, INC. | Takeda Manufacturing Singapore Pte Ltd | Takeda Manufacturing Austria AG | SGS Lab Simon | BioReliance Ltd | Sigma-Aldrich Pte Ltd | Shire Human Genetic Therapies Inc. | Charles River Laboratories Germany GmbH | OFI Technologie & Innovation GmbH | Siegfried Hameln GmbH | Hameln RDS
- Effective date
- 2026-09-25
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| ADZYNMA | TAKEDA PHARMACEUTICALS AMERICA, INC. | Takeda Manufacturing Singapore Pte Ltd | Takeda Manufacturing Austria AG | SGS Lab Simon | BioReliance Ltd | Sigma-Aldrich Pte Ltd | Shire Human Genetic Therapies Inc. | Charles River Laboratories Germany GmbH | OFI Technologie & Innovation GmbH | Siegfried Hameln GmbH | Hameln RDS | 2026-09-25 | HUMAN PRESCRIPTION DRUG LABEL |
| VONVENDI | Takeda Pharmaceuticals America, Inc. | Baxalta US Inc. | Siegfried Hameln GmbH | Baxalta Manufacturing Sàrl | 2026-07-28 | PLASMA DERIVATIVE |
| ADYNOVATE | Takeda Pharmaceuticals Amercia, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Baxalta Belgium Manufacturing SA | Baxalta Manufacturing Sàrl | Takeda Manufacturing Singapore Pte. Ltd. | 2026-05-28 | PLASMA DERIVATIVE |
| RIXUBIS | Takeda Pharmaceuticals America, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Takeda Manufacturing Singapore Pte. Ltd. | OFI Technologie & Innovation GmbH | 2026-05-12 | PLASMA DERIVATIVE |
| CEPROTIN - Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH | Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH | 2025-12-04 | PLASMA DERIVATIVE |
| Cinryze | Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Italia SPA | BAXALTA US INC. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH | Prothya Biosolutions Belgium | Prothya Biosolutions Netherlands B.V. | 2025-11-28 | PLASMA DERIVATIVE |
| RECOMBINATE ® [Antihemophilic Factor (Recombinant)] | Takeda Pharmaceuticals America, Inc. | Baxalta US Inc. | 2025-04-03 | PLASMA DERIVATIVE |
| ADVATE | Takeda Pharmaceuticals America, Inc. | Baxalta US INC | Baxalta Manufacturing Sarl | Takeda Manufacturing Austria AG | Takeda Manufacturing Singapore Pte. Ltd. | Siegfried Hameln GmbH | 2025-04-03 | PLASMA DERIVATIVE |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64764-515 | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CINRYZE (HUMAN C1-ESTERASE INHIBITOR) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 41 | Unmatched | 20241224_d53a911f-070d-498a-8a61-baab72b9d0fe.zip |
| 64764-515 | ADYNOVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED) KIT [TAKEDA PHARMACEUTICALS AMERCIA, INC.] | 22 | Unmatched | 20250331_ef290433-997f-4e98-86d6-42f6a99d6d18.zip |
| 64764-515 | RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 21 | Unmatched | 20250426_d99348b1-edad-41de-aed9-903a6f9f279f.zip |
| 64764-515 | VONVENDI (VON WILLEBRAND FACTOR (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 17 | Unmatched | 20230418_53b6d198-6175-4a26-8606-dc0d2a0f12d6.zip |
| 64764-515 | CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 14 | Unmatched | 20250110_926914a9-78b2-40ea-b37d-2a55c09bf275.zip |
| 64764-515 | ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 13 | Unmatched | 20250418_80fa03d2-cd4c-4155-9b57-1396c4fa42da.zip |
| 64764-515 | RIXUBIS (COAGULATION FACTOR IX (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 13 | Unmatched | 20250410_f5070a92-96b8-476a-a2dc-18b22d95e5e0.zip |
| 64764-515 | ADZYNMA (APADAMTASE ALFA) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 6 | Unmatched | 20240831_22728e96-efa0-46c1-bdd1-ad89a796d5e3.zip |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Nacl 0.9% Normal Saline Solution | SODIUM CHLORIDE | CHI FUNG TECHNOLOGY COMPANY | 5a53c4c8-c9de-700c-e063-6394a90a3ab5 | 2026-08-31 | Warnings | 451W47IQ8X |
| BMNP Nat Mur | NATRUM MURIATICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5a57ccfd-ab6f-cb2c-e063-6394a90ae9e6 | 2026-08-31 | Warnings | 451W47IQ8X |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | Cardinal Health 107, LLC | 4d524ace-9de5-4f62-9263-7cd88a36b67c | 2026-08-28 | Warnings | G2M7P15E5P |
| PEG3350 | POLYETHYLENE GLYCOL 3350 | Major Pharmaceuticals | 161629f6-6193-4712-bba7-7d5b174a9338 | 2026-08-28 | Warnings | G2M7P15E5P |
| Calcium Chloride | CALCIUM CHLORIDE | REMEDYREPACK INC. | 801f110c-7800-4689-a37a-f31d99c0f930 | 2026-08-28 | Adverse reactions | M4I0D6VV5M |
| Allergy Care | ADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | NaturalCare | f3ca7f5a-1448-4670-ac02-b47ffb6c5585 | 2026-08-27 | Warnings | 451W47IQ8X |
| Mix-In Laxative Packets | POLYETHYLENE GLYCOL 3350 | Wal-Mart Stores Inc | 0347c934-1e85-4f8d-8d35-bb07f16810ad | 2026-08-27 | Warnings | G2M7P15E5P |
| Calcium Chloride | CALCIUM CHLORIDE INJECTION | REMEDYREPACK INC. | 3089499b-142d-482e-889d-1db4da7b1152 | 2026-08-26 | Warnings, Adverse reactions | M4I0D6VV5M |
| KUGIG ALOE FOAMING INTIMATE WASH | INTIMATE CLEANSING FOAM | Hong Kong KangXing Centennial Management Limited | 59f4d398-1186-a168-e063-6294a90ab44b | 2026-08-26 | Warnings | 059QF0KO0R |
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | 451W47IQ8X |
| Electrolyte Plus | KALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUM | Deseret Biologicals, Inc. | e3564733-8b88-4753-9077-9d74004d8ec9 | 2026-08-25 | Warnings | HG18B9YRS7 451W47IQ8X |
| Sterile Water | WATER | REMEDYREPACK INC. | 5dd5d148-6e23-41de-bff5-551b2aea9598 | 2026-08-24 | Warnings, Adverse reactions | 059QF0KO0R |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | d5b44f79-5299-4b31-ba45-0e511cdbe17c | 2026-08-24 | Warnings | 451W47IQ8X |
| Rohto Max Strength | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | e4b49550-1ca3-4bd7-854d-409b53fa5e26 | 2026-08-20 | Warnings | 6OZP39ZG8H |
| Bio Combination 28 | SCHUESSLER SALTS | LDD Bioscience Private Limited | 597caf33-5107-9dec-e063-6294a90a5fcd | 2026-08-20 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | YYBA CORP | 597f3347-647c-3545-e063-6294a90abab2 | 2026-08-20 | Warnings | 451W47IQ8X |
| ADZYNMA | APADAMTASE ALFA | TAKEDA PHARMACEUTICALS AMERICA, INC. | 22728e96-efa0-46c1-bdd1-ad89a796d5e3 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | BLA125795 64764-130-01 64764-145-05 64764-140-05 64764-515-50 64764-135-01 64764-140 64764-145 2670300 2670313 2670311 2670293 758b0d1f-9d6c-42f9-a23b-6f75e9181842 22728e96-efa0-46c1-bdd1-ad89a796d5e3 |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88 | 2026-08-20 | Warnings, Adverse reactions | 451W47IQ8X |
| Sinusforce-HP | ARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA | BioActive Nutritional, Inc. | 53c96680-210b-4426-8b41-3b9a882848dd | 2026-08-20 | Warnings | 451W47IQ8X |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.