glycopyrrolate

Generic: glycopyrrolate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-363
Product ID 50268-363_2f8b2a36-ac60-7762-e063-6294a90ae573
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202675
Listing Expiration 2026-12-31
Marketing Start 2025-03-04

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa] cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268363
Hyphenated Format 50268-363

Supplemental Identifiers

RxCUI
197738
UNII
V92SO9WP2I

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 glycopyrrolate (source: ndc)
Generic Name glycopyrrolate (source: ndc)
Application Number ANDA202675 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-363-15) / 1 TABLET in 1 BLISTER PACK (50268-363-11)
source: ndc

Packages (1)

50268-363-15 50 BLISTER PACK in 1 BOX (50268-363-15) / 1 TABLET in 1 BLISTER PACK (50268-363-11)

Ingredients (1)

glycopyrrolate (1 mg/1)

Linked Drug Pages (1)

Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f8b2a36-ac60-7762-e063-6294a90ae573", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["197738"], "spl_set_id": ["bd497783-e2d1-130c-e053-2995a90a7fb9"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-363-15)  / 1 TABLET in 1 BLISTER PACK (50268-363-11)", "package_ndc": "50268-363-15", "marketing_start_date": "20250304"}], "brand_name": "Glycopyrrolate", "product_id": "50268-363_2f8b2a36-ac60-7762-e063-6294a90ae573", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "50268-363", "generic_name": "Glycopyrrolate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/1"}], "application_number": "ANDA202675", "marketing_category": "ANDA", "marketing_start_date": "20250304", "listing_expiration_date": "20261231"}