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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Rising Pharma Holdings, Inc. | 42870188-b1d7-4934-a6c0-310530497dac | 2025-11-07 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | d8b8d796-bfba-42af-a859-99d776871558 | 2025-11-07 | Adverse reactions | 451W47IQ8X |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 059QF0KO0R |
| MiraLAX | POLYETHYLENE GLYCOL 3350 | Cardinal Health 107, LLC | 1771d3bf-954d-49ea-b260-3d356e5dcfa5 | 2025-11-07 | Warnings | G2M7P15E5P |
| Bacteriostatic Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | 31188cdf-7bc8-4d78-bfaf-c1dc9f851fd4 | 2025-11-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | d3d29c8f-c326-4097-814a-7f4e08c67068 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE | B. Braun Medical Inc. | 01721071-af03-4894-95c1-10b8bc64b888 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Dextrose in Lactated Ringers | DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 190da07e-a616-46e6-b4e5-1c0ba39306e5 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | f6d82772-638c-4584-b9d3-8833669f5963 | 2025-11-05 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Bacteriostatic Water | BACTERIOSTATIC WATER | ProPharma Distribution | 42c6938e-f747-ae13-e063-6294a90a59a3 | 2025-11-04 | Warnings, Adverse reactions | 059QF0KO0R |
| Com-Pare2 Dual Yeast Relief Plus Multi-symptom Formula | CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHUR | TRP Company | 42b6b9b9-a673-0bba-e063-6394a90a8866 | 2025-11-03 | Warnings | 451W47IQ8X |
| 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 | HG18B9YRS7 OF5P57N2ZX 4QD397987E TE7660XO1C 2ZD004190S |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE | ICU Medical Inc. | d8ee14e9-6733-4813-9f21-2b043a5f7188 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | ICU Medical Inc. | 4555b1bf-6d97-4798-a63d-6d34291c85ce | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | ICU Medical Inc. | 9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 3cfdeee0-ff14-4341-8396-b11c2a037c60 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 5f372b75-d7a4-471e-8ac6-290040fc84b0 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | SODIUM CHLORIDE AND POTASSIUM CHLORIDE | ICU Medical Inc. | 243fe8fc-996a-4855-8daf-069628e547c4 | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.