pyridostigmine bromide

Generic: pyridostigmine bromide

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pyridostigmine bromide
Generic Name pyridostigmine bromide
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pyridostigmine bromide 60 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-3511
Product ID 0115-3511_3d2e45fb-a83b-4e76-b1cd-9caf2b00a804
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040502
Listing Expiration 2026-12-31
Marketing Start 2003-04-24

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01153511
Hyphenated Format 0115-3511

Supplemental Identifiers

RxCUI
903857
UPC
0301153511017
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 ANDA040502 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0115-3511-01)
  • 500 TABLET in 1 BOTTLE (0115-3511-02)
source: ndc

Packages (2)

0115-3511-01 100 TABLET in 1 BOTTLE (0115-3511-01) 0115-3511-02 500 TABLET in 1 BOTTLE (0115-3511-02)

Ingredients (1)

pyridostigmine bromide (60 mg/1)

Linked Drug Pages (1)

Pyridostigmine Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d2e45fb-a83b-4e76-b1cd-9caf2b00a804", "openfda": {"upc": ["0301153511017"], "unii": ["KVI301NA53"], "rxcui": ["903857"], "spl_set_id": ["0f56facf-1f0a-4ba5-876d-757b114dfa45"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0115-3511-01)", "package_ndc": "0115-3511-01", "marketing_start_date": "20030424"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0115-3511-02)", "package_ndc": "0115-3511-02", "marketing_start_date": "20030424"}], "brand_name": "Pyridostigmine Bromide", "product_id": "0115-3511_3d2e45fb-a83b-4e76-b1cd-9caf2b00a804", "dosage_form": "TABLET", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "0115-3511", "generic_name": "PYRIDOSTIGMINE BROMIDE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pyridostigmine Bromide", "active_ingredients": [{"name": "PYRIDOSTIGMINE BROMIDE", "strength": "60 mg/1"}], "application_number": "ANDA040502", "marketing_category": "ANDA", "marketing_start_date": "20030424", "listing_expiration_date": "20261231"}