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 table
LabelManufacturerEffective dateType
ADZYNMATAKEDA 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 RDS2026-09-25HUMAN PRESCRIPTION DRUG LABEL
VONVENDITakeda Pharmaceuticals America, Inc. | Baxalta US Inc. | Siegfried Hameln GmbH | Baxalta Manufacturing Sàrl2026-07-28PLASMA DERIVATIVE
ADYNOVATETakeda 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.2026-05-28PLASMA DERIVATIVE
RIXUBISTakeda Pharmaceuticals America, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Takeda Manufacturing Singapore Pte. Ltd. | OFI Technologie & Innovation GmbH2026-05-12PLASMA DERIVATIVE
CEPROTIN - Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbHTakeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH2025-12-04PLASMA DERIVATIVE
CinryzeTakeda 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.2025-11-28PLASMA DERIVATIVE
RECOMBINATE ® [Antihemophilic Factor (Recombinant)]Takeda Pharmaceuticals America, Inc. | Baxalta US Inc.2025-04-03PLASMA DERIVATIVE
ADVATETakeda Pharmaceuticals America, Inc. | Baxalta US INC | Baxalta Manufacturing Sarl | Takeda Manufacturing Austria AG | Takeda Manufacturing Singapore Pte. Ltd. | Siegfried Hameln GmbH2025-04-03PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-515CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CINRYZE (HUMAN C1-ESTERASE INHIBITOR) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]41Unmatched20241224_d53a911f-070d-498a-8a61-baab72b9d0fe.zip
64764-515ADYNOVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED) KIT [TAKEDA PHARMACEUTICALS AMERCIA, INC.]22Unmatched20250331_ef290433-997f-4e98-86d6-42f6a99d6d18.zip
64764-515RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]21Unmatched20250426_d99348b1-edad-41de-aed9-903a6f9f279f.zip
64764-515VONVENDI (VON WILLEBRAND FACTOR (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]17Unmatched20230418_53b6d198-6175-4a26-8606-dc0d2a0f12d6.zip
64764-515CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]14Unmatched20250110_926914a9-78b2-40ea-b37d-2a55c09bf275.zip
64764-515ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]13Unmatched20250418_80fa03d2-cd4c-4155-9b57-1396c4fa42da.zip
64764-515RIXUBIS (COAGULATION FACTOR IX (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]13Unmatched20250410_f5070a92-96b8-476a-a2dc-18b22d95e5e0.zip
64764-515ADZYNMA (APADAMTASE ALFA) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]6Unmatched20240831_22728e96-efa0-46c1-bdd1-ad89a796d5e3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN C1-ESTERASE INHIBITORACTIVE INGREDIENT6KIC4BB60GCINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
HUMAN C1-ESTERASE INHIBITORACTIVE MOIETY6KIC4BB60GCINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
ALANINEINACTIVE INGREDIENTOF5P57N2ZXCINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
SUCROSEINACTIVE INGREDIENTC151H8M554CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
THREONINEINACTIVE INGREDIENT2ZD004190SCINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
VALINEINACTIVE INGREDIENTHG18B9YRS7CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]23
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE INGREDIENTP89DR4NY54RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE MOIETYP89DR4NY54RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRRECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
CALCIUMINACTIVE INGREDIENTSY7Q814VUPRECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
HISTIDINEINACTIVE INGREDIENT4QD397987ERECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PRECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]10
PROTEIN CACTIVE INGREDIENT3Z6S89TXPWCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
PROTEIN CACTIVE MOIETY3Z6S89TXPWCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE INGREDIENTP89DR4NY54ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
COAGULATION FACTOR IX RECOMBINANT HUMANACTIVE INGREDIENT382L14738LRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE MOIETYP89DR4NY54ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
COAGULATION FACTOR IX RECOMBINANT HUMANACTIVE MOIETY382L14738LRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
GLUTATHIONEINACTIVE INGREDIENTGAN16C9B8OADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
HISTIDINEINACTIVE INGREDIENT4QD397987EADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
HISTIDINEINACTIVE INGREDIENT4QD397987ERIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
SUCROSEINACTIVE INGREDIENTC151H8M554RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
TREHALOSEINACTIVE INGREDIENTB8WCK70T7IADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]2

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.

Matched openFDA labels page 18 of 64 · 1,278 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough DaytimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.804e0e7a-20eb-128b-e053-2991aa0aa82c2025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: 451W47IQ8X
Hair and Nail TonicAVENA, DNA, ELAEIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS, HEPAR SUIS, KALI SULPH, NAT MUR, NICOTINAMIDUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, THUJA OCC, THYROIDINUM, URTICA UR.Eight and Company L.L.C35bda785-b3a7-4928-aaea-27bf9fb6abb52025-12-18WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution3f79fb8b-d0e8-db2a-e063-6394a90ac1362025-12-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: GAN16C9B8O
Body BalanceARALIA QUIN, ARNICA, AVENA, CARDUUS MAR, ELAEIS, GLANDULA SUPRARENALIS SUIS, NAT MUR, PHOSPHORICUM AC, THUJA OCCEight and Company L.L.C876cc0cf-c7a7-4656-adf9-1eff9bb626872025-12-18WarningsExact identifier
unii: 451W47IQ8X
ADRENOPLEXCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS BOVINE, SPLEEN (SUIS), CARDUUS MARIANUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.3c53c23e-7654-4e46-acf1-edb0d605ff3b2025-12-18WarningsExact identifier
unii: 451W47IQ8X
VermasodeARTEMISIA VULGARIS, CHELIDONIUM MAJUS, GRANATUM, SPIGELIA ANTHELMIA, RATANHIA, ARSENICUM ALBUM, FERRUM METALLICUM, CALCAREA CARBONICA, CINA, GAERTNER BACILLUS, GRAPHITES, MERCURIUS DULCIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, VERMIN NOSODENatural Creations, Inc180b5641-5692-42d4-8472-fdadccebd7462025-12-18WarningsExact identifier
unii: 451W47IQ8X
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: 451W47IQ8X
Equate Yeast ReliefCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURWAL-MART STORES INCd96aa608-ed8a-36cd-e053-2a95a90ac2862025-12-17WarningsExact identifier
unii: 451W47IQ8X
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 451W47IQ8X
Vital-FLBODY FLUID BALANCEVitaltiy Works, Inc.13207197-7ef7-49a3-8970-5f98299a75d22025-12-17WarningsExact identifier
unii: 451W47IQ8X
Epl-Cell RepairCELL REPAIR AIDVitality Works, Inc.134d1cc1-2300-409d-b562-98ce807e77b32025-12-17WarningsExact identifier
unii: M4I0D6VV5M
Woman PowerAGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCCEight and Company L.L.C614d47de-742b-4944-89c8-59f2f58dc8b92025-12-17WarningsExact identifier
unii: 451W47IQ8X
PSORIASIS HPARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMNatural Creations, Inc.d2522637-fd16-4246-90d8-f90fb224550e2025-12-16WarningsExact identifier
unii: 451W47IQ8X
MoodARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCCNatural Creations, Inc7f143f30-2b72-4e6c-985c-8d3a485dbdb42025-12-16WarningsExact identifier
unii: 451W47IQ8X
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsExact identifier
unii: G2M7P15E5P
IODIUM HPBARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FUCUS VESICULOSUS, IODINE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED, THYROIDNatural Creations, Inc.9353d604-e168-4df1-9726-e965c9fc2c782025-12-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.