Pyridostigmine Bromide
Pyridostigmine Bromide Extended-Release Tablets (180 mg) Rx only
Approved
Approval ID
013a6524-6eb9-4dbf-b29c-9aec2f40d2d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2019
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code0115-1404
Application NumberANDA203184
Product Classification
M
Marketing Category
C73584
G
Generic Name
PYRIDOSTIGMINE BROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2019
FDA Product Classification
INGREDIENTS (6)
PYRIDOSTIGMINE BROMIDEActive
Quantity: 180 mg in 1 1
Code: KVI301NA53
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT