glycopyrrolate

Generic: glycopyrrolate

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler precision dose, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-073
Product ID 68094-073_0a84301a-febc-4552-97d6-1fd16f191545
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204438
Listing Expiration 2026-12-31
Marketing Start 2025-07-07

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 68094073
Hyphenated Format 68094-073

Supplemental Identifiers

RxCUI
999961
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 ANDA204438 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 50 BAG in 1 CASE (68094-073-58) / 1 SYRINGE, PLASTIC in 1 BAG / 5 mL in 1 SYRINGE, PLASTIC (68094-073-01)
source: ndc

Packages (1)

68094-073-58 50 BAG in 1 CASE (68094-073-58) / 1 SYRINGE, PLASTIC in 1 BAG / 5 mL in 1 SYRINGE, PLASTIC (68094-073-01)

Ingredients (1)

glycopyrrolate (1 mg/5mL)

Linked Drug Pages (1)

Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a84301a-febc-4552-97d6-1fd16f191545", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["e58f860b-e955-4d71-a128-93bd3812b08d"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 BAG in 1 CASE (68094-073-58)  / 1 SYRINGE, PLASTIC in 1 BAG / 5 mL in 1 SYRINGE, PLASTIC (68094-073-01)", "package_ndc": "68094-073-58", "marketing_start_date": "20250707"}], "brand_name": "Glycopyrrolate", "product_id": "68094-073_0a84301a-febc-4552-97d6-1fd16f191545", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "68094-073", "generic_name": "Glycopyrrolate", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA204438", "marketing_category": "ANDA", "marketing_start_date": "20250707", "listing_expiration_date": "20261231"}