Pyridostigmine Bromide
Pyridostigmine Bromide Oral Solution USP
Approved
Approval ID
56999559-274e-44ea-a317-29366fdca908
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
Acella Pharmaceuticals, LLC
DUNS: 825380939
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 Code42192-626
Application NumberANDA212405
Product Classification
M
Marketing Category
C73584
G
Generic Name
pyridostigmine bromide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (10)
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PYRIDOSTIGMINE BROMIDEActive
Quantity: 60 mg in 5 mL
Code: KVI301NA53
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT