glycopyrrolate

Generic: glycopyrrolate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6213
Product ID 0641-6213_9cafddcc-42f5-486b-9a17-46d75bd6227b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017558
Listing Expiration 2026-12-31
Marketing Start 2025-08-28

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 06416213
Hyphenated Format 0641-6213

Supplemental Identifiers

RxCUI
2101490 2101495
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 NDA017558 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 SYRINGE, GLASS in 1 CARTON (0641-6213-10) / 2 mL in 1 SYRINGE, GLASS (0641-6213-01)
source: ndc

Packages (1)

0641-6213-10 10 SYRINGE, GLASS in 1 CARTON (0641-6213-10) / 2 mL in 1 SYRINGE, GLASS (0641-6213-01)

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": "9cafddcc-42f5-486b-9a17-46d75bd6227b", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["2101490", "2101495"], "spl_set_id": ["960d2dd0-008d-4ec1-ba2e-9388b28b23e2"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE, GLASS in 1 CARTON (0641-6213-10)  / 2 mL in 1 SYRINGE, GLASS (0641-6213-01)", "package_ndc": "0641-6213-10", "marketing_start_date": "20250828"}], "brand_name": "Glycopyrrolate", "product_id": "0641-6213_9cafddcc-42f5-486b-9a17-46d75bd6227b", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0641-6213", "generic_name": "Glycopyrrolate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "NDA017558", "marketing_category": "NDA", "marketing_start_date": "20250828", "listing_expiration_date": "20261231"}