glycopyrrolate

Generic: glycopyrrolate

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler xiromed, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-902
Product ID 70700-902_c69bb9fb-1204-4258-bdf0-4c83cb2067b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212612
Listing Expiration 2026-12-31
Marketing Start 2021-11-09

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 70700902
Hyphenated Format 70700-902

Supplemental Identifiers

RxCUI
238212
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 (70700-902-25) / 5 mL in 1 VIAL (70700-902-22)
source: ndc

Packages (1)

70700-902-25 25 VIAL in 1 CARTON (70700-902-25) / 5 mL in 1 VIAL (70700-902-22)

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": "c69bb9fb-1204-4258-bdf0-4c83cb2067b9", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["238212"], "spl_set_id": ["f777c813-3232-d744-8bcf-58e86fb929bd"], "manufacturer_name": ["Xiromed, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (70700-902-25)  / 5 mL in 1 VIAL (70700-902-22)", "package_ndc": "70700-902-25", "marketing_start_date": "20211109"}], "brand_name": "Glycopyrrolate", "product_id": "70700-902_c69bb9fb-1204-4258-bdf0-4c83cb2067b9", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70700-902", "generic_name": "Glycopyrrolate", "labeler_name": "Xiromed, LLC", "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": "20211109", "listing_expiration_date": "20261231"}