FDA.reportPublic FDA data

Mestinon

Product NDC
0187-3012
11-digit product format
001873012
Labeler code
0187
Product ID
0187-3012_f6bf0102-bf43-4f3b-8667-39362bc9cfbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyridostigmine bromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Bausch Health US, LLC
Application
NDA015193
Marketing category
NDA
Marketing start
1965-01-25
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
60 mg/5mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mestinon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOSTIGMINE BROMIDE60 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903843, 903845, 903847, 903849, 903857, 903859

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-3012-20Mestinon473 mL in 1 BOTTLESOLUTION47320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-3012-20ML - Milliliter0187-3012ac3b7552-e144-4640-b614-bb9af39fd14c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pyridostigmine bromideACTIVE INGREDIENTKVI301NA53MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
pyridostigmineACTIVE MOIETY19QM69HH21MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
alcoholINACTIVE INGREDIENT3K9958V90MMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
carnauba waxINACTIVE INGREDIENTR12CBM0EIZMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
glycerinINACTIVE INGREDIENTPDC6A3C0OXMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
lactic acidINACTIVE INGREDIENT33X04XA5ATMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
lactoseINACTIVE INGREDIENTJ2B2A4N98GMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
magnesium stearateINACTIVE INGREDIENT70097M6I30MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
sorbitolINACTIVE INGREDIENT506T60A25RMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
stearic acidINACTIVE INGREDIENT4ELV7Z65APMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
sucroseINACTIVE INGREDIENTC151H8M554MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
tribasic calcium phosphateINACTIVE INGREDIENT91D9GV0Z28MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10
waterINACTIVE INGREDIENT059QF0KO0RMESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-3012MESTINON (PYRIDOSTIGMINE BROMIDE) SOLUTION MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US, LLC]20Current NDC, Legacy NDC, 1 package rows20230202_a851795e-b7a8-40c3-9922-5e79d3eb4d92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903849Mestinon 180 MG Extended Release Oral TabletPSNa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903845Mestinon 60 MG in 5 mL Oral SolutionPSNa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903859Mestinon 60 MG Oral TabletPSNa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903847pyRIDostigmine bromide 180 MG Extended Release Oral TabletPSNa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSNa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903857pyRIDostigmine bromide 60 MG Oral TabletPSNa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903845pyridostigmine bromide 12 MG/ML Oral Solution [Mestinon]SBDa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903849pyridostigmine bromide 180 MG Extended Release Oral Tablet [Mestinon]SBDa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903859pyridostigmine bromide 60 MG Oral Tablet [Mestinon]SBDa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCDa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903847pyridostigmine bromide 180 MG Extended Release Oral TabletSCDa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903857pyridostigmine bromide 60 MG Oral TabletSCDa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903845Mestinon 12 MG/ML Oral SolutionSYa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903849Mestinon 180 MG Extended Release Oral TabletSYa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903849Mestinon 180 MG Timespan TabletSYa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903859Mestinon 60 MG Oral TabletSYa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903845Mestinon 60 MG per 5 ML SyrupSYa851795e-b7a8-40c3-9922-5e79d3eb4d9220
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSYa851795e-b7a8-40c3-9922-5e79d3eb4d9220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-3012-2000187301220473 mL in 1 BOTTLE (0187-3012-20) 473 ml1965-01-250000-00-00NoNoCurrent