FDA.reportPublic FDA data

Pyridostigmine Bromide

Product NDC
58657-811
11-digit product format
586570811
Labeler code
58657
Product ID
58657-811_4aa4cfc7-d427-5306-e063-6394a90a628d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PYRIDOSTIGMINE BROMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA211181
Marketing category
ANDA
Marketing start
2024-06-15
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
60 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pyridostigmine Bromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOSTIGMINE BROMIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5Product name920230112
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-811-012026-01-29C16284748780-149896155-b07e-586f-e063-e6dba90add90Pyridostigmine Bromide Tablets, USP
58657-811-302026-01-29C16284748780-149896155-b07e-586f-e063-e6dba90add90Pyridostigmine Bromide Tablets, USP
58657-811-902026-01-29C16284748780-149896155-b07e-586f-e063-e6dba90add90Pyridostigmine Bromide Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-811-01Pyridostigmine Bromide100 in 1 BOTTLETABLET1002
58657-811-30Pyridostigmine Bromide30 in 1 BOTTLETABLET302
58657-811-90Pyridostigmine Bromide90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-811PYRIDOSTIGMINE BROMIDE TABLET [METHOD PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20240619_1aa7a886-c726-cc91-e063-6294a90a1af1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903857pyRIDostigmine bromide 60 MG Oral TabletPSN1aa7a886-c726-cc91-e063-6294a90a1af12
903857pyridostigmine bromide 60 MG Oral TabletSCD1aa7a886-c726-cc91-e063-6294a90a1af12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-811-0158657081101100 TABLET in 1 BOTTLE (58657-811-01) 100 tablet2024-06-15NoNoCurrent
58657-811-305865708113030 TABLET in 1 BOTTLE (58657-811-30) 30 tablet2024-06-15NoNoCurrent
58657-811-905865708119090 TABLET in 1 BOTTLE (58657-811-90) 90 tablet2024-06-15NoNoCurrent