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
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 table
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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HUMAN C1-ESTERASE INHIBITOR	ACTIVE INGREDIENT	6KIC4BB60G	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
HUMAN C1-ESTERASE INHIBITOR	ACTIVE MOIETY	6KIC4BB60G	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
ALANINE	INACTIVE INGREDIENT	OF5P57N2ZX	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
THREONINE	INACTIVE INGREDIENT	2ZD004190S	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
VALINE	INACTIVE INGREDIENT	HG18B9YRS7	CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS]	23
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE INGREDIENT	P89DR4NY54	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE MOIETY	P89DR4NY54	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
ALBUMIN HUMAN	INACTIVE INGREDIENT	ZIF514RVZR	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	RECOMBINATE (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	10
PROTEIN C	ACTIVE INGREDIENT	3Z6S89TXPW	CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	6
PROTEIN C	ACTIVE MOIETY	3Z6S89TXPW	CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	6
ALBUMIN HUMAN	INACTIVE INGREDIENT	ZIF514RVZR	CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	6
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	6
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE INGREDIENT	P89DR4NY54	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
COAGULATION FACTOR IX RECOMBINANT HUMAN	ACTIVE INGREDIENT	382L14738L	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE MOIETY	P89DR4NY54	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
COAGULATION FACTOR IX RECOMBINANT HUMAN	ACTIVE MOIETY	382L14738L	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
GLUTATHIONE	INACTIVE INGREDIENT	GAN16C9B8O	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	2
TREHALOSE	INACTIVE INGREDIENT	B8WCK70T7I	ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	2
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ADVATE (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 64 of 64 · 1,278 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spleen-Pro T018	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Guangzhou Renuma Medical Systems Co., Ltd	bc2b70bd-2a4a-46fb-b3d8-d69b61056b89	2017-10-26	Warnings	Exact identifier unii: 451W47IQ8X
Female Vitality T010	CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA	Guangzhou Renuma Medical Systems Co., Ltd	694f0c36-b656-471a-9f38-2efb5193e05a	2017-10-20	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Cardio Tonic	KALI MURIATICUM, KALI PHOSPHORICUM, PLANTAGO MAJOR, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, HEART (BOVINE), L-CARNITINE, L-VALINE, THYROIDINUM (SUIS), ABROTANUM (ARTEMISIA ABROTANUM), IODIUM, LECITHIN, SPIGELIA ANTHELMIA	BioActive Nutritional, Inc.	2c252ba6-f147-4c22-b432-cd603a9623ac	2017-08-14	Warnings	Exact identifier unii: HG18B9YRS7
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	886f889b-f3cf-4197-b307-6cfa88c89436	2017-05-04		Exact identifier unii: 451W47IQ8X
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)	Energetix Corp	9883c502-9782-451e-9eec-c54d7b054f31	2017-01-31	Warnings	Exact identifier unii: 451W47IQ8X
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: B22547B95K
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2a96096d-43cc-49b7-af53-b53c17f41001	2014-07-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21		Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21		Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
43f74854-1e47-48f8-bb31-2804f54886c2			d53a911f-070d-498a-8a61-baab72b9d0fe	2010-11-01	Warnings, Adverse reactions	Exact identifier spl set id: d53a911f-070d-498a-8a61-baab72b9d0fe
926914a9-78b2-40ea-b37d-2a55c09bf275			926914a9-78b2-40ea-b37d-2a55c09bf275	2010-08-09	Warnings, Adverse reactions	Exact identifier spl set id: 926914a9-78b2-40ea-b37d-2a55c09bf275
6576655e-8d2f-48e8-9ed0-504695addc86			d99348b1-edad-41de-aed9-903a6f9f279f	2010-05-26	Warnings, Adverse reactions	Exact identifier spl set id: d99348b1-edad-41de-aed9-903a6f9f279f

Reported adverse events (FAERS/openFDA)#

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