pyridostigmine bromide
Pyridostigmine Bromide Tablets, USP Rx only
Approved
Approval ID
36284496-e56e-466c-9b56-6007bb5bb699
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2021
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pyridostigmine bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-6622
Application NumberANDA205650
Product Classification
M
Marketing Category
C73584
G
Generic Name
pyridostigmine bromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2017
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PYRIDOSTIGMINE BROMIDEActive
Quantity: 60 mg in 1 1
Code: KVI301NA53
Classification: ACTIB
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT