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 58 of 64 · 1,278 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	8b44bfd3-70a4-4b47-bc7b-590f63b8cc75	2022-02-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	ANTICOAGULANT SODIUM CITRATE SOLUTION	Fenwal, Inc.	a63da38d-1fea-4ee0-a70b-55c891a5ebcc	2022-02-11		Exact identifier unii: B22547B95K
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)	ANTICOAGULANT SODIUM CITRATE SOLUTION	Fenwal, Inc.	ac8971a9-36d0-43c9-9121-ba5e58c28bed	2022-02-11		Exact identifier unii: B22547B95K
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	e44c41ae-c9c8-4dd8-ba6c-cebb585378aa	2022-01-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Walgreens	SODIUM CHLORIDE	WALGREEN COMPANY	d6b9d4fc-b758-be32-e053-2995a90a2523	2022-01-29	Warnings	Exact identifier unii: 451W47IQ8X
Extra Strenght Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID CORPORATION	d5b30fb2-4052-4a0c-e053-2a95a90aacd5	2022-01-16	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID	d583067e-1133-7d7d-e053-2a95a90a1e36	2022-01-13	Warnings	Exact identifier unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	648da2bc-bc91-4295-9e46-d3055cdc2418	2022-01-08	Warnings	Exact identifier unii: 451W47IQ8X
SinuCleanse Nasal Drip	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	d5129a91-50e7-6b94-e053-2a95a90a2b30	2022-01-08	Warnings	Exact identifier unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist Daily Care	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC	d5131ab2-8213-3659-e053-2a95a90ab2ab	2022-01-08	Warnings	Exact identifier unii: 451W47IQ8X
Headek Nasal	BELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics	976b9c85-68c9-46a5-9012-53cb24683b03	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
EAR RX	ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM	Miami Beach Pediatrics pa	a8753f88-4b8a-472f-a4bd-f2e9cec83610	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
Lyme Disease Support 1	ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.	OHM PHARMA INC.	035e75d6-aeef-4dfd-b076-9d3d8e4a5086	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
Anxiety Stress Relief	ARG NIT, AUR MET, AVENA, GELSEMIUM, HYOSCYAMUS, IGNATIA, MOSCHUS, NAT MUR, PASSIFLORA, STANNUM MET, VALERIANA.	OHM PHARMA INC.	b736ec93-199a-4d19-882a-186c0e2adb11	2021-12-29	Warnings	Exact identifier unii: 451W47IQ8X
TH-101	CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROB	Temple Health Nutrition, LLC	d54bb860-560c-4f8f-9aea-a0b7774cc92b	2021-12-29	Warnings	Exact identifier unii: C151H8M554 unii: HG18B9YRS7 unii: 451W47IQ8X unii: 2ZD004190S
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4829ee40-c2d7-4e17-a606-75e8a8628413	2021-12-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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