glycopyrrolate

Generic: glycopyrrolate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

glycopyrrolate 1 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6709
Product ID 0904-6709_0f08ec01-fce9-498e-810e-f74ad4ff24b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207201
Listing Expiration 2026-12-31
Marketing Start 2017-02-27

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 09046709
Hyphenated Format 0904-6709

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 ANDA207201 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6709-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6709-61 100 BLISTER PACK in 1 CARTON (0904-6709-61) / 1 TABLET in 1 BLISTER PACK

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": "0f08ec01-fce9-498e-810e-f74ad4ff24b2", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["197738"], "spl_set_id": ["6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6709-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6709-61", "marketing_start_date": "20170227"}], "brand_name": "Glycopyrrolate", "product_id": "0904-6709_0f08ec01-fce9-498e-810e-f74ad4ff24b2", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0904-6709", "generic_name": "Glycopyrrolate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/1"}], "application_number": "ANDA207201", "marketing_category": "ANDA", "marketing_start_date": "20170227", "listing_expiration_date": "20261231"}