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 |
|---|---|---|---|---|---|---|
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | d310d170-5eeb-471b-af1a-0e845001d21d | 2025-11-02 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 009bef3c-e8ac-46be-b564-a2556adf0081 | 2025-10-31 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Lactated Ringers and Dextrose | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE | ICU Medical Inc. | 237b39fa-916e-4a54-99c8-4ae9ad54f056 | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Normosol-R and Dextrose | DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | ead1fca3-eff4-478f-8a8f-67510f80151a | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 0e089a44-0cee-4804-8f6f-8508508ddb5c | 2025-10-30 | Warnings, Adverse reactions | 451W47IQ8X |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 189b8ac6-e346-454f-b501-7645590ca4f8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | A-S Medication Solutions | 4f31a33e-1f60-4aa7-b1dc-a3c011c03a70 | 2025-10-29 | Warnings | G2M7P15E5P |
| Cold and Cough 4 Kids | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Hyland's Inc. | e06599ca-fc94-4b2c-829e-f3d4ec866ed6 | 2025-10-29 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 97007188-43fe-416c-a87b-6ccc4d9ae2ec | 2025-10-29 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | 05f326e6-10e4-4ceb-8a23-f53c592f00b8 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Lactated Ringers and Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Corporation | 6acc9f96-7088-45a7-b48f-1a861e3467ab | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Lactated Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE | Baxter Healthcare Company | dad7735c-709b-40ea-ab7a-15577e24a966 | 2025-10-29 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| WALMART SALINE | SALINE NASAL (SODIUM CHLORIDE) | WALMART STORES INC | 06906744-49a5-4bab-8539-af2d235df9e8 | 2025-10-28 | Warnings | 451W47IQ8X |
| Saline | NASAL | PUBLIX SUPER MARKETS, INC | 19841567-9511-43d6-ba4e-d1e1bd3481a4 | 2025-10-28 | Warnings | 451W47IQ8X |
| Bacteriostatic Water | WATER | Henry Schein, Inc. | a833502e-a622-4e81-8c58-cef6ccb6c4c9 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Polyethylene Glycol 3350 Powder for Solution | POLYETHYLENE GLYCOL, UNSPECIFIED | VALLEY MEDICAL PRODUCTS, LLC | ae595e97-6d29-44f8-a647-fcd54fcda5b1 | 2025-10-27 | Warnings | G2M7P15E5P |
| Calcium Chloride | CALCIUM CHLORIDE | Henry Schein, Inc. | 0a3b8e0e-efb0-465b-84cb-d120b3096ebd | 2025-10-27 | Warnings, Adverse reactions | M4I0D6VV5M |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.