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 50 of 64 · 1,278 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AnubisMed	SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION	ANUBIS COSMETICS SL	e99d92c4-8768-9c0a-e053-2a95a90a609e	2023-09-05	Warnings	Exact identifier unii: 023C2WHX2V unii: 059QF0KO0R
AnubisMed	AZELAIC ACID, SALICYLIC ACID	ANUBIS COSMETICS SL	ebf3153d-30f5-54e4-e053-2995a90a74b1	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
AnubisMed	GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID	ANUBIS COSMETICS SL	eca95dde-cb57-2ab6-e053-2995a90af84f	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN	ANUBIS COSMETICS SL	eb9244ea-6102-3cbe-e053-2a95a90ab8f6	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL	ANUBIS COSMETICS SL	eb8e5beb-4452-58c2-e053-2a95a90a66e0	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Protective Line	ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE	ANUBIS COSMETICS SL	ec83846f-11c0-8f59-e053-2995a90ab9d2	2023-09-01	Warnings	Exact identifier unii: 023C2WHX2V unii: 059QF0KO0R
Anubis Barcelona Regul Oil	CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE	ANUBIS COSMETICS SL	eb68c3ab-7835-1a1c-e053-2995a90a0d66	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul OIl	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT	ANUBIS COSMETICS SL	eb905bd0-c600-b8b2-e053-2995a90ad259	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT	ANUBIS COSMETICS SL	eb7c418b-8bee-26a3-e053-2a95a90a4e96	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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