glycopyrrolate

Generic: glycopyrrolate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-801
Product ID 65219-801_516b2ac1-7eab-4d63-a0d0-97245858a1d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209328
Listing Expiration 2026-12-31
Marketing Start 2023-12-31

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219801
Hyphenated Format 65219-801

Supplemental Identifiers

RxCUI
1731582
UPC
0365219801009
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 ANDA209328 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (65219-801-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-801-00)
source: ndc

Packages (1)

65219-801-01 25 VIAL, SINGLE-DOSE in 1 CARTON (65219-801-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-801-00)

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": "516b2ac1-7eab-4d63-a0d0-97245858a1d0", "openfda": {"upc": ["0365219801009"], "unii": ["V92SO9WP2I"], "rxcui": ["1731582"], "spl_set_id": ["250eeef7-b1a9-45e7-a927-7807232e10be"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (65219-801-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (65219-801-00)", "package_ndc": "65219-801-01", "marketing_start_date": "20231231"}], "brand_name": "Glycopyrrolate", "product_id": "65219-801_516b2ac1-7eab-4d63-a0d0-97245858a1d0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "65219-801", "generic_name": "Glycopyrrolate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA209328", "marketing_category": "ANDA", "marketing_start_date": "20231231", "listing_expiration_date": "20261231"}