FDA.reportPublic FDA data

NDC 63629-9592-01 - Glycopyrrolate

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
63629-9592
Requested NDC
63629-9592-01
Package NDCs from labels
63629-9592-1, 63629-9592-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate - Bryant Ranch PrepackBryant Ranch Prepack2024-01-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9592-1Glycopyrrolate473 mL in 1 BOTTLESOLUTION473101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9592GLYCOPYRROLATE SOLUTION [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20240114_579d2499-6520-41fb-ae52-f3d8b9af8950.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9592-1ML - Milliliter63629-95922a4cc1f3-1557-4b2f-9b8b-6f1badc2d59012023-02-06

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 7 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEXiromed LLC29618edf-39b0-022a-9875-9d865450d3182022-04-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEXiromed, LLCf777c813-3232-d744-8bcf-58e86fb929bd2022-04-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.516cc4f8-3583-4405-ab66-29d4fcc56d052022-03-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.d5a18d74-0d40-46e2-aa0a-41d18609a5362022-03-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATEBE Pharmaceuticals Inc.d9df3900-a8c2-438b-8971-ba11ff91f90b2022-02-24Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATESomerset Therapeutics, LLCa46c5ec1-a1b4-46fc-9b37-8da7f0c983d62022-01-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAuroMedics Pharma LLCeaebb511-1738-4d11-b9bb-317a8d41316a2021-12-22Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATENivagen Pharmaceuticals, Inc.7cb1ecbe-1e7a-4b39-8e1d-0c20f145e1772021-10-29Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEAlembic Labs LLCdb178372-51d2-4194-bbe2-da9acb1cfd532020-12-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATECivica, Inc.9f7f1ebf-58e8-4ae7-8157-1595df8ad6f42020-02-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: A2I8C7HI9T
GlycopyrrolateGLYCOPYRROLATEDr. Reddy's Laboratories Limited725529e8-9c4b-4108-690a-e4f3914397362016-11-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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