FDA Product

Pyridostigmine Bromide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Pyridostigmine Bromide

FDA Product Code

42192-626

Regulatory Information

NDC Product Code

42192-626

Application Number

ANDA212405

Marketing Category

C73584

Effective Date

October 9, 2023

Territorial Authority

USA

FDA Title

Pyridostigmine Bromide Oral Solution USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAcella Pharmaceuticals, LLC

DUNS Number

825380939

Active Ingredients

PYRIDOSTIGMINE BROMIDE

Quantity: 60 mg in 5 mL

Code: KVI301NA53

Class Code: ACTIB

Inactive Ingredients

LACTIC ACID

Code: 33X04XA5AT

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

PYRIDOSTIGMINE

Code: 19QM69HH21

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