pyridostigmine bromide

Generic: pyridostigmine bromide

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pyridostigmine bromide
Generic Name pyridostigmine bromide
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pyridostigmine bromide 60 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-659
Product ID 68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205650
Listing Expiration 2026-12-31
Marketing Start 2015-08-07

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382659
Hyphenated Format 68382-659

Supplemental Identifiers

RxCUI
903857
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 ANDA205650 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-659-01)
  • 500 TABLET in 1 BOTTLE (68382-659-05)
  • 30 TABLET in 1 BOTTLE (68382-659-06)
  • 90 TABLET in 1 BOTTLE (68382-659-16)
source: ndc

Packages (4)

68382-659-01 100 TABLET in 1 BOTTLE (68382-659-01) 68382-659-05 500 TABLET in 1 BOTTLE (68382-659-05) 68382-659-06 30 TABLET in 1 BOTTLE (68382-659-06) 68382-659-16 90 TABLET in 1 BOTTLE (68382-659-16)

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": "5439e6be-2d67-4bbd-b72f-3364cb62f907", "openfda": {"unii": ["KVI301NA53"], "rxcui": ["903857"], "spl_set_id": ["44e8c2dd-3931-4508-9fa7-5a660d6dfddb"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-659-01)", "package_ndc": "68382-659-01", "marketing_start_date": "20150807"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-659-05)", "package_ndc": "68382-659-05", "marketing_start_date": "20150807"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-659-06)", "package_ndc": "68382-659-06", "marketing_start_date": "20150807"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-659-16)", "package_ndc": "68382-659-16", "marketing_start_date": "20150807"}], "brand_name": "pyridostigmine bromide", "product_id": "68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907", "dosage_form": "TABLET", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "68382-659", "generic_name": "pyridostigmine bromide", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pyridostigmine bromide", "active_ingredients": [{"name": "PYRIDOSTIGMINE BROMIDE", "strength": "60 mg/1"}], "application_number": "ANDA205650", "marketing_category": "ANDA", "marketing_start_date": "20150807", "listing_expiration_date": "20261231"}