glycopyrrolate

Generic: glycopyrrolate

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-543
Product ID 84549-543_3edcc39d-0e2a-4585-e063-6394a90ad512
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210927
Listing Expiration 2026-12-31
Marketing Start 2019-03-20

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 84549543
Hyphenated Format 84549-543

Supplemental Identifiers

RxCUI
1731582
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 ANDA210927 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (84549-543-25)
source: ndc

Packages (1)

84549-543-25 1 mL in 1 VIAL, SINGLE-DOSE (84549-543-25)

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": "3edcc39d-0e2a-4585-e063-6394a90ad512", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["1731582"], "spl_set_id": ["3edcc39d-0e29-4585-e063-6394a90ad512"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (84549-543-25)", "package_ndc": "84549-543-25", "marketing_start_date": "20250915"}], "brand_name": "GLYCOPYRROLATE", "product_id": "84549-543_3edcc39d-0e2a-4585-e063-6394a90ad512", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "84549-543", "generic_name": "glycopyrrolate", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYCOPYRROLATE", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA210927", "marketing_category": "ANDA", "marketing_start_date": "20190320", "listing_expiration_date": "20261231"}