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 54 of 64 · 1,278 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clearlax	POLYETHYLENE GLYCOL 3350	H E B	0b4b752d-045d-4ff0-8e50-5607d1a841a7	2023-01-26	Warnings	Exact identifier unii: G2M7P15E5P
Good Sense Clear Lax	POLYETHYLENE GLYCOL 3350	L. Perrigo Company	435db89c-1e32-4da5-b7d0-15e407162715	2023-01-24	Warnings	Exact identifier unii: G2M7P15E5P
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86463b98-58f5-7f65-e053-2a91aa0ad3a2	2023-01-23		Exact identifier unii: 451W47IQ8X
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8645f130-6a19-ae73-e053-2991aa0ab05b	2023-01-23		Exact identifier unii: 451W47IQ8X
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8645eb60-65d1-9d6c-e053-2991aa0a94ef	2023-01-23		Exact identifier unii: 451W47IQ8X
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8644ffef-f0e6-5c06-e053-2a91aa0ae83d	2023-01-23		Exact identifier unii: 451W47IQ8X
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86466614-b8ee-2335-e053-2a91aa0aa67c	2023-01-23		Exact identifier unii: 451W47IQ8X
Rehydrate	AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN	ParaDocs All Natural, Inc.	648fab10-c46b-420f-a42c-6642009d83fb	2023-01-10	Warnings	Exact identifier unii: 059QF0KO0R
Chip Cravings	COUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUS	Dr. Donna Restivo DC	719ef104-88f3-4db5-9c3a-1ac9a1a63c26	2023-01-10	Warnings	Exact identifier unii: C151H8M554
PSORIASIS	ARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUM	Zorex International	b5b8bb82-4d36-4faa-b023-e48066f4521c	2023-01-09	Warnings	Exact identifier unii: 451W47IQ8X
Virimmune	ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2021-2022), MORBILLINUM	Deseret Biologicals, Inc.	56555cb5-89e5-4a30-8ebe-ce2c01bdd426	2023-01-03	Warnings	Exact identifier unii: 451W47IQ8X
AILGENO	AMANITA MUSCARIA FRUITING BODY, ARSENIC TRIOXIDE, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, GLECHOMA HEDERACEA FLOWERING TOP, GRINDELIA HIRSUTULA WHOLE, AND SODIUM CHLORIDE	PEKANA Naturheilmittel GmbH	4e24f727-4c83-46b6-9549-8f66bd135647	2022-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Weight Management HP	ARSENIC TRIOXIDE, GOLD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, IODINE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SULFUR	Natural Creations, Inc.	93736f0b-a419-4b90-84b0-f27e4c71299b	2022-12-20	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Liebel-Flarsheim Company LLC	e4540d03-06b4-4b4d-b859-75c13e5c20dd	2022-12-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
NATRUM MURIATICUM	SODIUM CHLORIDE	Hyland's Inc.	21ee53eb-b41a-4d2e-8037-12973d2b73d9	2022-12-19	Warnings	Exact identifier unii: 451W47IQ8X
Cataracc	ARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET.	Newton Laboratories, Inc.	eff981fd-5436-7c34-e053-2a95a90a3e8e	2022-12-16	Warnings	Exact identifier unii: 451W47IQ8X
CVS Health Sterile Saline Mist	SODIUM CHLORIDE	CVS Pharmacy	4df47f14-8268-4cd3-b29e-96446743e2f6	2022-12-16	Warnings	Exact identifier unii: 451W47IQ8X
Cold and Cough	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL	Wal-Mart Stores, Inc.	69349b4d-6c5b-7121-e053-2991aa0a3594	2022-12-15	Warnings	Exact identifier unii: 451W47IQ8X
Childrens Cold and Cough Nighttime	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL	Walgreen Company	80c41b65-0411-4395-e053-2a91aa0a9df9	2022-12-15	Warnings	Exact identifier unii: 451W47IQ8X
Childrens Cold and Cough	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL	Walgreen Company	80b5f707-a839-7729-e053-2991aa0a1c56	2022-12-15	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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