glycopyrrolate

Generic: glycopyrrolate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler endo usa, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-042
Product ID 49884-042_afe8b809-9378-4d06-8965-5e30b2deb18d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204438
Listing Expiration 2026-12-31
Marketing Start 2022-01-04

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 49884042
Hyphenated Format 49884-042

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 16 mL in 1 BOTTLE (49884-042-33)
source: ndc

Packages (1)

49884-042-33 16 mL in 1 BOTTLE (49884-042-33)

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": "afe8b809-9378-4d06-8965-5e30b2deb18d", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["ff65c5d3-7ba9-4315-a884-199151eb45a5"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 mL in 1 BOTTLE (49884-042-33)", "package_ndc": "49884-042-33", "marketing_start_date": "20220104"}], "brand_name": "Glycopyrrolate", "product_id": "49884-042_afe8b809-9378-4d06-8965-5e30b2deb18d", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "49884-042", "generic_name": "Glycopyrrolate", "labeler_name": "Endo USA, 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": "20220104", "listing_expiration_date": "20261231"}