glycate

Generic: glycopyrrolate

Labeler: intra-sana laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycate
Generic Name glycopyrrolate
Labeler intra-sana laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glycopyrrolate 1.5 mg/1

Manufacturer
Intra-Sana Laboratories

Identifiers & Regulatory

Product NDC 80056-160
Product ID 80056-160_feae0733-6244-4791-b717-581bde769f02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091522
Listing Expiration 2027-12-31
Marketing Start 2022-04-01

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 80056160
Hyphenated Format 80056-160

Supplemental Identifiers

RxCUI
1247658 1437975
UNII
V92SO9WP2I

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 glycate (source: ndc)
Generic Name glycopyrrolate (source: ndc)
Application Number ANDA091522 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (80056-160-10)
source: ndc

Packages (1)

80056-160-10 100 TABLET in 1 BOTTLE (80056-160-10)

Ingredients (1)

glycopyrrolate (1.5 mg/1)

Linked Drug Pages (1)

Glycate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "feae0733-6244-4791-b717-581bde769f02", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["1247658", "1437975"], "spl_set_id": ["830ba1be-bef3-417c-a915-964cc6005b92"], "manufacturer_name": ["Intra-Sana Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (80056-160-10)", "package_ndc": "80056-160-10", "marketing_start_date": "20220401"}], "brand_name": "Glycate", "product_id": "80056-160_feae0733-6244-4791-b717-581bde769f02", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "80056-160", "generic_name": "Glycopyrrolate", "labeler_name": "Intra-Sana Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1.5 mg/1"}], "application_number": "ANDA091522", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20271231"}