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 4 of 6 · 119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CuvposaGLYCOPYRROLATEMerz Pharmaceuticals, LLCd200bd44-9856-4104-a29e-a4cca3db67372024-12-19Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack5ee5f433-fd99-4c8d-8263-b8956d4896202024-12-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATESaptalis Pharmaceuticals, LLC.3e6f8091-d6fe-4c8f-b897-606a70bf74bc2024-11-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLCccafb5c2-86dd-4bb2-883a-c13e3171227c2024-10-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack987ba524-361e-49c3-9e00-550a787485422024-10-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack48a8356e-377e-45ef-a1bf-e9ffec0517492024-10-08Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackfcb295e4-038f-4d4f-8786-4fbcd1d3c2982024-10-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack33bbc475-2fe3-48ab-8a9d-56d13053593e2024-10-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATESomerset Therapeutics, LLC48cfbd5a-b133-4720-9bd7-65296064ea3c2024-08-31Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackbfccdb26-5047-4b54-9732-ffac2d78e4d12024-05-29Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLC685aaf64-1a64-42f9-a96f-4764d650c26f2024-05-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
PREVDUONEOSTIGMINE METHYLSULFATE AND GLYCOPYRROLATEEndo USAdd8ad38f-247b-4948-a13c-8f3a4921b4f12024-04-10Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirst9be0ad4e-3efa-1a24-e053-2995a90a60d52024-02-22Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAmerican Regent, Inc.62267afe-1a73-4623-984e-646db590ec5b2024-02-07Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstc4c3be3a-ea28-864f-e053-2a95a90a701a2024-01-30Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirste76bc0e4-68f5-70b4-e053-2a95a90a451e2024-01-22Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack579d2499-6520-41fb-ae52-f3d8b9af89502024-01-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATENorthStar RxLLCed22456b-b488-49ec-b96b-2541f5f3c9552024-01-10Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEFH2 Pharma LLC18ca98ed-522d-470f-bb22-908bbd7d489a2023-12-31Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC0933e843-df2a-3d32-e063-6394a90a10372023-11-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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