glycopyrrolate

Generic: glycopyrrolate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glycopyrrolate 2 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4537
Product ID 70518-4537_462959a6-be3c-2c07-e063-6394a90a5509
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212696
Listing Expiration 2026-12-31
Marketing Start 2025-12-17

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 705184537
Hyphenated Format 70518-4537

Supplemental Identifiers

RxCUI
197739
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 ANDA212696 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4537-0) / 1 TABLET in 1 POUCH (70518-4537-1)
source: ndc

Packages (1)

70518-4537-0 100 POUCH in 1 BOX (70518-4537-0) / 1 TABLET in 1 POUCH (70518-4537-1)

Ingredients (1)

glycopyrrolate (2 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": "462959a6-be3c-2c07-e063-6394a90a5509", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["197739"], "spl_set_id": ["5d7a742e-2bcf-4db4-a07c-f669938e4068"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4537-0)  / 1 TABLET in 1 POUCH (70518-4537-1)", "package_ndc": "70518-4537-0", "marketing_start_date": "20251217"}], "brand_name": "GLYCOPYRROLATE", "product_id": "70518-4537_462959a6-be3c-2c07-e063-6394a90a5509", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70518-4537", "generic_name": "GLYCOPYRROLATE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYCOPYRROLATE", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "2 mg/1"}], "application_number": "ANDA212696", "marketing_category": "ANDA", "marketing_start_date": "20251217", "listing_expiration_date": "20261231"}