glycopyrrolate

Generic: glycopyrrolate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-023
Product ID 76045-023_1925138e-94b7-4e29-815e-f6681943a734
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214919
Listing Expiration 2026-12-31
Marketing Start 2022-04-21

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 76045023
Hyphenated Format 76045-023

Supplemental Identifiers

RxCUI
2473383
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 (source: ndc)
Generic Name glycopyrrolate (source: ndc)
Application Number NDA214919 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (76045-023-30) / 3 mL in 1 SYRINGE (76045-023-00)
source: ndc

Packages (1)

76045-023-30 10 SYRINGE in 1 CARTON (76045-023-30) / 3 mL in 1 SYRINGE (76045-023-00)

Ingredients (1)

glycopyrrolate (.2 mg/mL)

Linked Drug Pages (1)

Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "1925138e-94b7-4e29-815e-f6681943a734", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["2473383"], "spl_set_id": ["685aaf64-1a64-42f9-a96f-4764d650c26f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (76045-023-30)  / 3 mL in 1 SYRINGE (76045-023-00)", "package_ndc": "76045-023-30", "marketing_start_date": "20220421"}], "brand_name": "Glycopyrrolate", "product_id": "76045-023_1925138e-94b7-4e29-815e-f6681943a734", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "76045-023", "generic_name": "Glycopyrrolate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "NDA214919", "marketing_category": "NDA", "marketing_start_date": "20220421", "listing_expiration_date": "20261231"}