glyrx-pf

Generic: glycopyrrolate

Labeler: exela pharma sciences, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name glyrx-pf
Generic Name glycopyrrolate
Labeler exela pharma sciences, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Exela Pharma Sciences, LLC

Identifiers & Regulatory

Product NDC 51754-6001
Product ID 51754-6001_442634f7-9858-421d-91db-5bfdb21dcf13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210997
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

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 517546001
Hyphenated Format 51754-6001

Supplemental Identifiers

RxCUI
1731582 1731590 2371710 2371715 2371718 2371796 2473383 2473384
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 glyrx-pf (source: ndc)
Generic Name glycopyrrolate (source: ndc)
Application Number NDA210997 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6001-4) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

51754-6001-4 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6001-4) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

glycopyrrolate (.2 mg/mL)

Linked Drug Pages (1)

GLYRX-PF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "442634f7-9858-421d-91db-5bfdb21dcf13", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["1731582", "1731590", "2371710", "2371715", "2371718", "2371796", "2473383", "2473384"], "spl_set_id": ["2189f3f5-39dc-4e85-b7c6-9515ded59686"], "manufacturer_name": ["Exela Pharma Sciences, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6001-4)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51754-6001-4", "marketing_start_date": "20180801"}], "brand_name": "GLYRX-PF", "product_id": "51754-6001_442634f7-9858-421d-91db-5bfdb21dcf13", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "51754-6001", "generic_name": "glycopyrrolate", "labeler_name": "Exela Pharma Sciences, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYRX-PF", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "NDA210997", "marketing_category": "NDA", "marketing_start_date": "20180801", "listing_expiration_date": "20261231"}