NDC 63402-681-01 - UTIBRON 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
63402-681
Requested NDC
63402-681-01
Package NDCs from labels
63402-681-01, 63402-681-60, 63402-681-06, 63402-681-02, 63402-681-12
Manufacturer
Sunovion Pharmaceuticals Inc.
Effective date
2019-05-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
UTIBRON NEOHALER - Sunovion Pharmaceuticals Inc.Sunovion Pharmaceuticals Inc.2019-05-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63402-681-01EA - Each63402-681fdf9a6c3-5389-43b6-b079-50d744dc12f612018-04-19
63402-681-06EA - Each63402-6819eef7d49-3376-4482-b546-cd4a9989790412018-04-19
63402-681-60EA - Each63402-681c91b1e50-982d-4197-8a4c-105b40d16fab12018-06-11

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 2 of 6 · 119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.a338ef22-c243-4075-b02d-bcd5b590104a2026-03-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.fafea739-87d0-4421-833f-eb066791504c2026-03-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATELifestar Pharma LLC0f4a4b94-71e0-49ed-8f1e-c760e4dd31372026-03-25Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMajor Pharmaceuticals6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a2026-03-19Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATEBionpharma Inc.512d3f1e-c35c-87c2-e063-6394a90a8de02026-03-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATENCS HealthCare of KY, LLC dba Vangard Labs5ed930b7-a36e-4bf8-b1d1-dad238d3dd182026-02-25Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack10ea264f-e157-4e13-9d79-b4228daf359d2026-02-17Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEFlorida Pharmaceutical Products, LLC2cda1ed5-10bb-4651-acbf-be44ad7096652026-02-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycateGLYCOPYRROLATEIntra-Sana Laboratories830ba1be-bef3-417c-a915-964cc6005b922026-01-13Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepackeaf38b98-006f-4f4e-bc1c-6fe381f44b362026-01-07Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepackb96c54a1-b8a5-4132-ae6d-725e0e5b91f42026-01-07Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Glycopyrrolate Oral SolutionGLYCOPYRROLATEAJENAT PHARMACEUTICALS LLC7049feaf-004a-481f-b129-996b21c3170a2025-12-29Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEJvet Pharmaceuticals LLC4b335c67-4f8f-47e5-abfc-f8c2c15496d72025-12-19Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEAurolife Pharma LLC677f8495-a870-45b6-bb65-75b449f040ce2025-12-11Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEChartwell RX, LLC5773cf63-4006-4d8f-b53b-c84bcfe19e4a2025-12-10Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATERising Pharma Holdings, Inc.58c4cb1f-59b8-4be9-a222-2264ca077d932025-12-03Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATESolco Healthcare US, LLC2972f22e-378c-450b-8869-1354a9bd0ffc2025-11-30Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATESolco Healthcare US, LLC3707f06a-6cba-4f5c-86ab-fb95bc2a933c2025-11-30Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution430635e8-7c9e-77f6-e063-6294a90a4c8a2025-11-07Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.83602e34-7a8c-4606-b43e-23ab909b6c1a2025-11-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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