FDA.reportPublic FDA data

NDC 63402-675-01 - ARCAPTA NEOHALER

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
63402-675
Requested NDC
63402-675-01
Package NDCs from labels
63402-675-01, 63402-675-30, 63402-675-02, 63402-675-06
Manufacturer
Sunovion Pharmaceuticals Inc.
Effective date
2020-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ARCAPTA NEOHALER - Sunovion Pharmaceuticals Inc.Sunovion Pharmaceuticals Inc.2020-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63402-675-01EA - Each63402-6752c1ee963-4476-4518-a6b1-aa4a6d876e4312018-01-12
63402-675-30EA - Each63402-675ad3b7f59-f8f5-4beb-b06f-9e7bccdc168d12018-01-12

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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b68719dc-6a70-44d8-bee7-7b96ca58a8ade82416ba-23b9-4d40-a41d-baba8e11751b2021-07-30Warnings, Adverse reactionsExact identifier
spl set id: e82416ba-23b9-4d40-a41d-baba8e11751b

Reported adverse events (FAERS/openFDA)#

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