glycopyrrolate

Generic: glycopyrrolate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3829
Product ID 0781-3829_eaf4151c-b7ea-4b3a-e053-2995a90adf17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211334
Listing Expiration 2026-12-31
Marketing Start 2019-07-22

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813829
Hyphenated Format 0781-3829

Supplemental Identifiers

RxCUI
238212 1731582 1731590
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 ANDA211334 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0781-3829-96) / 5 mL in 1 VIAL (0781-3829-75)
source: ndc

Packages (1)

0781-3829-96 25 VIAL in 1 CARTON (0781-3829-96) / 5 mL in 1 VIAL (0781-3829-75)

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": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "eaf4151c-b7ea-4b3a-e053-2995a90adf17", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["cb1ae370-ec4f-4114-9860-8f736f72b545"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0781-3829-96)  / 5 mL in 1 VIAL (0781-3829-75)", "package_ndc": "0781-3829-96", "marketing_start_date": "20190722"}], "brand_name": "Glycopyrrolate", "product_id": "0781-3829_eaf4151c-b7ea-4b3a-e053-2995a90adf17", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0781-3829", "generic_name": "Glycopyrrolate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA211334", "marketing_category": "ANDA", "marketing_start_date": "20190722", "listing_expiration_date": "20261231"}