NDC 64764-135 - 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: 64764-135
Package NDCs from labels: 64764-135-01
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: 2024-08-30
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	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64764-135-01	ADZYNMA	1500 [iU] in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1500 [iU]	1500 [iU] in 1[iU]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64764-135	ADZYNMA (APADAMTASE ALFA) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6	Unmatched	20240831_22728e96-efa0-46c1-bdd1-ad89a796d5e3.zip