pyridostigmine bromide

Generic: pyridostigmine bromide

Labeler: acella pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pyridostigmine bromide
Generic Name pyridostigmine bromide
Labeler acella pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

pyridostigmine bromide 60 mg/5mL

Manufacturer
Acella Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 42192-626
Product ID 42192-626_40422b8d-3f5d-6590-e063-6394a90a1532
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212405
Listing Expiration 2026-12-31
Marketing Start 2023-10-09

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42192626
Hyphenated Format 42192-626

Supplemental Identifiers

RxCUI
903843
UPC
0342192626164
UNII
KVI301NA53

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pyridostigmine bromide (source: ndc)
Generic Name pyridostigmine bromide (source: ndc)
Application Number ANDA212405 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (42192-626-16)
source: ndc

Packages (1)

42192-626-16 473 mL in 1 BOTTLE (42192-626-16)

Ingredients (1)

pyridostigmine bromide (60 mg/5mL)

Linked Drug Pages (1)

Pyridostigmine Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40422b8d-3f5d-6590-e063-6394a90a1532", "openfda": {"upc": ["0342192626164"], "unii": ["KVI301NA53"], "rxcui": ["903843"], "spl_set_id": ["56999559-274e-44ea-a317-29366fdca908"], "manufacturer_name": ["Acella Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (42192-626-16)", "package_ndc": "42192-626-16", "marketing_start_date": "20231009"}], "brand_name": "Pyridostigmine Bromide", "product_id": "42192-626_40422b8d-3f5d-6590-e063-6394a90a1532", "dosage_form": "SOLUTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "42192-626", "generic_name": "pyridostigmine bromide", "labeler_name": "Acella Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pyridostigmine Bromide", "active_ingredients": [{"name": "PYRIDOSTIGMINE BROMIDE", "strength": "60 mg/5mL"}], "application_number": "ANDA212405", "marketing_category": "ANDA", "marketing_start_date": "20231009", "listing_expiration_date": "20261231"}