glycopyrrolate oral solution

Generic: glycopyrrolate

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

Drug Facts

Product Profile

Brand Name glycopyrrolate oral solution
Generic Name glycopyrrolate
Labeler granules pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-106
Product ID 70010-106_44f401d0-0f25-2def-e063-6294a90a79cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214735
Listing Expiration 2026-12-31
Marketing Start 2025-08-19

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 70010106
Hyphenated Format 70010-106

Supplemental Identifiers

RxCUI
999961
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 glycopyrrolate oral solution (source: ndc)
Generic Name glycopyrrolate (source: ndc)
Application Number ANDA214735 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (70010-106-44)
source: ndc

Packages (1)

70010-106-44 473 mL in 1 BOTTLE (70010-106-44)

Ingredients (1)

glycopyrrolate (1 mg/5mL)

Linked Drug Pages (1)

Glycopyrrolate Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44f401d0-0f25-2def-e063-6294a90a79cf", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["0f05c5d3-9c41-4dae-88d1-18cbddc69487"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (70010-106-44)", "package_ndc": "70010-106-44", "marketing_start_date": "20250819"}], "brand_name": "Glycopyrrolate Oral Solution", "product_id": "70010-106_44f401d0-0f25-2def-e063-6294a90a79cf", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70010-106", "generic_name": "Glycopyrrolate", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate Oral Solution", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA214735", "marketing_category": "ANDA", "marketing_start_date": "20250819", "listing_expiration_date": "20261231"}