glycopyrrolate

Generic: glycopyrrolate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-378
Product ID 68083-378_b0deaef8-f0eb-4979-8452-5bf0449fc521
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212612
Listing Expiration 2026-12-31
Marketing Start 2019-10-09

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 68083378
Hyphenated Format 68083-378

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0368083379018
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 ANDA212612 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-378-25) / 5 mL in 1 VIAL (68083-378-01)
source: ndc

Packages (1)

68083-378-25 25 VIAL in 1 CARTON (68083-378-25) / 5 mL in 1 VIAL (68083-378-01)

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": "b0deaef8-f0eb-4979-8452-5bf0449fc521", "openfda": {"upc": ["0368083379018"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["d670bd26-8a44-44be-90e1-107d4c380233"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-378-25)  / 5 mL in 1 VIAL (68083-378-01)", "package_ndc": "68083-378-25", "marketing_start_date": "20191009"}], "brand_name": "Glycopyrrolate", "product_id": "68083-378_b0deaef8-f0eb-4979-8452-5bf0449fc521", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "68083-378", "generic_name": "Glycopyrrolate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA212612", "marketing_category": "ANDA", "marketing_start_date": "20191009", "listing_expiration_date": "20261231"}