NDC 70428-011-11 - Qbrexza

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
70428-011
Requested NDC
70428-011-11
Package NDCs from labels
70428-011-11, 70428-011-12
Manufacturer
Journey Medical Corporation | Aphena Pharma Solutions, LLC
Effective date
2022-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Qbrexza - Journey Medical Corporation | Aphena Pharma Solutions, LLCJourney Medical Corporation | Aphena Pharma Solutions, LLC2022-01-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70428-011-11EA - Each70428-0115ddccef4-837c-4d64-8e86-b7a9966f6b2312019-04-11
70428-011-12EA - Each70428-011b1bc7828-63b3-4737-9b80-7bdbb685923812018-09-05

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QbrexzaGLYCOPYRRONIUMJourney Medical Corporation5b372650-e56e-47a5-93e2-c0c2920170592026-05-21Warnings, Adverse reactionsExact identifier
application number: NDA210361
unii: 1PVF6JLU7B
c56af57e-1ebb-4507-9474-11acdd6ca2b56b985380-1256-4fb3-b89a-6df2c6a6d12e2022-01-17Warnings, Adverse reactionsExact identifier
spl id: c56af57e-1ebb-4507-9474-11acdd6ca2b5
spl set id: 6b985380-1256-4fb3-b89a-6df2c6a6d12e

Reported adverse events (FAERS/openFDA)#

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