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 |
|---|---|---|---|---|---|---|
| Kids Cold and Cough Daytime Grape Flavor | ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR | Hyland's Consumer Health Inc. | e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d | 2022-08-16 | Warnings | 451W47IQ8X |
| Sterile Saline Kids Mist PediaMeds | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | e5c5b580-1d9f-3081-e053-2995a90a8031 | 2022-08-08 | Warnings | 451W47IQ8X |
| Sterile Saline Kids Mist SinuCleanse Breathe | SODIUM CHLORIDE | ASCENT CONSUMER PRODUCTS, INC. | e5c5c313-046f-b0a7-e053-2a95a90a2a07 | 2022-08-08 | Warnings | 451W47IQ8X |
| 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 | HG18B9YRS7 OF5P57N2ZX 4QD397987E TE7660XO1C 2ZD004190S |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | 123bd10a-90c7-499e-97f6-acf7e0f0fb4e | 2022-07-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | fad9615f-7004-415d-9f69-ee9ff95f0067 | 2022-07-12 | Warnings | 451W47IQ8X |
| BHI Constipation | DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED | MediNatura Inc | 0365b75b-fee4-4c1d-89ab-c692bdd73f75 | 2022-07-07 | Warnings | 451W47IQ8X |
| Natrium Muriaticum 6X | SODIUM CHLORIDE | Seroyal USA | 0ebf18de-12fe-0bc4-e054-00144ff88e88 | 2022-07-07 | Warnings | 451W47IQ8X |
| Good Sense Clear Lax | POLYETHYLENE GLYCOL 3350 | Proficient Rx LP | 0858a914-4812-4e4d-82f8-ecf93d43ef3b | 2022-07-01 | Warnings | G2M7P15E5P |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | 6OZP39ZG8H |
| Erogetone | ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA | Energique, Inc. | 1e872ecd-e7a5-463d-9832-47b7046096db | 2022-06-28 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| GAVILAX | POLYETHYLENE GLYCOL 3350 | Proficient Rx LP | 199d6173-3fad-49e4-88fe-bde7223ed4c3 | 2022-06-01 | Warnings | G2M7P15E5P |
| Cardioplegic Solution | POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Fresenius Kabi, USA, LLC | eb360dc4-88d6-4b28-9b61-bc359e16bd22 | 2022-05-27 | Warnings, Adverse reactions | 451W47IQ8X M4I0D6VV5M |
| Calcarea Muriatica | CALCAREA MURIATICA | Hahnemann Laboratories, INC. | df517477-164b-33cc-e053-2a95a90a2083 | 2022-05-18 | M4I0D6VV5M | |
| ACD Blood-Pack Units (PL 146 PLASTIC) | ANTICOAGULANT CITRATE DEXTROSE (ACD) | Fenwal, Inc. | ba894daa-688e-4a9e-bd74-e71797f951bb | 2022-04-27 | B22547B95K | |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 24a08a93-df23-474b-873e-c59ec8855f9f | 2022-03-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Wild Horse 777 Moisturizing Nasal | SODIUM CHLORIDE | Wild Horse 777, Inc. | b0b4dadd-11fa-3dbb-e053-2995a90a2097 | 2022-03-14 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | cc14fafd-3dcd-4fc8-bdbd-6f355c375768 | 2022-02-23 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.