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 30 of 64 · 1,278 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nauzene	SODIUM CITRATE	Kobayashi Healthcare International, Inc.	a60660b2-c5db-45a0-885f-de93e655380d	2025-04-29	Warnings	Exact identifier unii: B22547B95K
Sinus Wash Packet	SODIUM BICARBONATE, SODIUM CHLORIDE	BETTER LIVING BRANDS LLC	33ee7b77-0871-4df8-e063-6394a90ac479	2025-04-29	Warnings	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	6d43fa91-0940-437f-ba70-b2d3f977593e	2025-04-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Camber Consumer Care Inc	b321a7f5-f80b-4a51-9fd9-2c21fc1cae9b	2025-04-23	Warnings	Exact identifier unii: G2M7P15E5P
good neighbor pharmacy clearlax	POLYETHYLENE GLYCOL 3350	Amerisource Bergen	e0b419b6-6ce0-4aaa-948f-dee5b2ec2082	2025-04-17	Warnings	Exact identifier unii: G2M7P15E5P
Nat Mur 6X	SODIUM CHLORIDE	Hyland's Inc.	dcf0e2ac-3b69-3ae4-e053-2a95a90aaf41	2025-04-10	Warnings	Exact identifier unii: 451W47IQ8X
Winco	POLYETHYLENE GLYCOL 3350	WINCO FOODS	d649f758-a46f-4864-8718-878ee5a74bfc	2025-04-10	Warnings	Exact identifier unii: G2M7P15E5P
Bestmade Natural Products BM68 Pellets	PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARB	Bestmade Natural Products	32423a04-31d1-7477-e063-6394a90aecac	2025-04-08	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Nat Mur 8x	NATRUM MURIATICUM	Bestmade Natural Products	31e0e16d-e4df-cd9a-e063-6394a90abcc1	2025-04-03	Warnings	Exact identifier unii: 451W47IQ8X
Eye Wash	WATER	CMC Group Inc.	6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561	2025-04-02	Warnings	Exact identifier unii: 059QF0KO0R
Kidneyforce-HP	ARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA	BioActive Nutritional, Inc.	0c0f0c0c-10c2-47eb-aad6-bbffb6e16799	2025-04-02	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE TABLET	Belleview Bioscience LLC	31195e8f-d4de-9e37-e063-6294a90a4156	2025-03-24	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products BIO13 Lactose Free	CALC PHOS KALI SULPH, KALI PHOS, NAT MUR	Bestmade Natural Products	303590c5-8a66-aafc-e063-6294a90a1a4e	2025-03-23	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products BIO13	CALC PHOS, KALI SULPH, KALI PHOS, NAT MUR	Bestmade Natural Products	2fffab7f-0d4b-0e96-e063-6294a90a34d8	2025-03-23	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Nat Mur	NAT MUR	Bestmade Natural Products	e9e9a4f6-5104-3c6f-e053-2995a90a1165	2025-03-21	Warnings	Exact identifier unii: 451W47IQ8X
Pituitary Liquescence	CAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHIN	Nutritional Specialties, Inc.	292ca967-abe8-4ae1-b2fe-942531a1e14a	2025-03-20	Warnings	Exact identifier unii: 451W47IQ8X
Anxiety HP	ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUM	Energique, Inc.	191393fa-5f36-43c0-a183-09258eef9bda	2025-03-20	Warnings	Exact identifier unii: 451W47IQ8X
HYDRA NEB	SODIUM CHLORIDE	Venture Healthcare Ltd	30b184bf-2451-d96b-e063-6294a90a43c7	2025-03-19	Warnings	Exact identifier unii: 451W47IQ8X
HYDRA NEB	SODIUM CHLORIDE	Laboratoire Unither	30b244c0-84bb-a0a0-e063-6394a90a9dee	2025-03-19	Warnings	Exact identifier unii: 451W47IQ8X
Polyethylene Gycol 3350	POLYETHYLENE GYCOL 3350	Allegiant Health	13851c9a-a226-481b-9db5-bc7053997df7	2025-03-17	Warnings	Exact identifier unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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