Mestinon

Basic Information

Product Name

Mestinon

FDA Product Code

0187-3013

Regulatory Information

NDC Product Code

0187-3013

Application Number

NDA011665

Marketing Category

C73594

Effective Date

December 2, 2020

Territorial Authority

USA

FDA Title

MESTINON (pyridostigmine bromide) Oral Solution, USP ORAL SOLUTION TABLETS and TIMESPAN TABLETS

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

magnesium stearate

Code: 70097M6I30

Class Code: IACT

carnauba wax

Code: R12CBM0EIZ

Class Code: IACT

pyridostigmine bromide

Quantity: 180 mg in 1 1

Code: KVI301NA53

Class Code: ACTIB

silicon dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

tribasic calcium phosphate

Code: 91D9GV0Z28

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

Active Moieties

pyridostigmine

Code: 19QM69HH21

Basic Information

Regulatory Information

Company Information

Active Ingredients

magnesium stearate

carnauba wax

silicon dioxide

tribasic calcium phosphate

WATER

ISOPROPYL ALCOHOL

Active Moieties

pyridostigmine