FDA.reportPublic FDA data

NDC 46594-750-01 - Pyridostigmine bromide

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
46594-750
Requested NDC
46594-750-01
Package NDCs from labels
46594-750-01, 46594-750-02
Manufacturer
Valeant Canada Limited
Effective date
2008-10-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pyridostigmine bromide - Valeant Canada LimitedValeant Canada Limited2008-10-27HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46594-750-01Pyridostigmine bromide21 in 1 BLISTER PACKTABLET211
46594-750-02Pyridostigmine bromide10 in 1 BAGTABLET101
46594-750-02Pyridostigmine bromide21 in 1 BLISTER PACKTABLET211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46594-750PYRIDOSTIGMINE BROMIDE TABLET [VALEANT CANADA LIMITED]13 package rows20081114_68E8ABB9-979E-4C84-9E17-0C6584958AE3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyridostigmine bromideACTIVE INGREDIENTKVI301NA53PYRIDOSTIGMINE BROMIDE TABLET [VALEANT CANADA LIMITED]1
PyridostigmineACTIVE MOIETY19QM69HH21PYRIDOSTIGMINE BROMIDE TABLET [VALEANT CANADA LIMITED]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4PYRIDOSTIGMINE BROMIDE TABLET [VALEANT CANADA LIMITED]1
lactose anhydrousINACTIVE INGREDIENTPYRIDOSTIGMINE BROMIDE TABLET [VALEANT CANADA LIMITED]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APPYRIDOSTIGMINE BROMIDE TABLET [VALEANT CANADA LIMITED]1

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 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pyridostigmine BromidePYRIDOSTIGMINE BROMIDESurgeon General-Department of the Army (TSG-DA)0b296555-c32f-42db-b5f3-ea981a3dd2f82025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903841
Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEMethod Pharmaceuticals, LLCe756717f-941b-42f2-ba3b-03798c005ae72025-10-21Warnings, Adverse reactionsExact identifier
rxcui: 903841
Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals of New York LLC91ca7bcf-d2cc-4cb3-bfbe-c294fd7075242023-12-31Warnings, Adverse reactionsExact identifier
rxcui: 903841
C5F839EC-20C9-F291-CC33-658755CF3B2668E8ABB9-979E-4C84-9E17-0C6584958AE32008-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: C5F839EC-20C9-F291-CC33-658755CF3B26
spl set id: 68E8ABB9-979E-4C84-9E17-0C6584958AE3

Reported adverse events (FAERS/openFDA)#

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