glycopyrrolate

Generic: glycopyrrolate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9681
Product ID 0143-9681_8ed339c6-d65f-4b1c-8e23-301f75258c2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090963
Listing Expiration 2026-12-31
Marketing Start 2011-09-21

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439681
Hyphenated Format 0143-9681

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 ANDA090963 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0143-9681-25) / 2 mL in 1 VIAL (0143-9681-01)
source: ndc

Packages (1)

0143-9681-25 25 VIAL in 1 CARTON (0143-9681-25) / 2 mL in 1 VIAL (0143-9681-01)

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": "8ed339c6-d65f-4b1c-8e23-301f75258c2e", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["516cc4f8-3583-4405-ab66-29d4fcc56d05"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0143-9681-25)  / 2 mL in 1 VIAL (0143-9681-01)", "package_ndc": "0143-9681-25", "marketing_start_date": "20110921"}], "brand_name": "Glycopyrrolate", "product_id": "0143-9681_8ed339c6-d65f-4b1c-8e23-301f75258c2e", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0143-9681", "generic_name": "Glycopyrrolate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA090963", "marketing_category": "ANDA", "marketing_start_date": "20110921", "listing_expiration_date": "20261231"}