glycopyrrolate

Generic: glycopyrrolate

Labeler: piramal critical care inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler piramal critical care inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Piramal Critical Care Inc

Identifiers & Regulatory

Product NDC 66794-205
Product ID 66794-205_3f1431b2-9fb7-4739-e063-6394a90a1ddc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210842
Listing Expiration 2026-12-31
Marketing Start 2019-07-11

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 66794205
Hyphenated Format 66794-205

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 ANDA210842 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (66794-205-41) / 20 mL in 1 VIAL, GLASS (66794-205-02)
source: ndc

Packages (1)

66794-205-41 10 VIAL, GLASS in 1 CARTON (66794-205-41) / 20 mL in 1 VIAL, GLASS (66794-205-02)

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": "3f1431b2-9fb7-4739-e063-6394a90a1ddc", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["83d70378-011b-4ce3-e053-2991aa0a22be"], "manufacturer_name": ["Piramal Critical Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (66794-205-41)  / 20 mL in 1 VIAL, GLASS (66794-205-02)", "package_ndc": "66794-205-41", "marketing_start_date": "20190711"}], "brand_name": "Glycopyrrolate", "product_id": "66794-205_3f1431b2-9fb7-4739-e063-6394a90a1ddc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "66794-205", "generic_name": "Glycopyrrolate", "labeler_name": "Piramal Critical Care Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA210842", "marketing_category": "ANDA", "marketing_start_date": "20190711", "listing_expiration_date": "20261231"}