glycopyrrolate

Generic: glycopyrrolate

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-4601
Product ID 0517-4601_ad03d273-8f44-48f2-bc0e-4dd8dbf08507
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089335
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

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 05174601
Hyphenated Format 0517-4601

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0305174601252 0305174605250 0305174602259 0305174620253
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 ANDA089335 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4601-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0517-4601-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4601-25) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "ad03d273-8f44-48f2-bc0e-4dd8dbf08507", "openfda": {"upc": ["0305174601252", "0305174605250", "0305174602259", "0305174620253"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["62267afe-1a73-4623-984e-646db590ec5b"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4601-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0517-4601-25", "marketing_start_date": "19900930"}], "brand_name": "Glycopyrrolate", "product_id": "0517-4601_ad03d273-8f44-48f2-bc0e-4dd8dbf08507", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0517-4601", "generic_name": "Glycopyrrolate", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA089335", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}