glycopyrrolate

Generic: glycopyrrolate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .4 mg/2mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1395
Product ID 70121-1395_eef9f866-2de4-4bc2-881d-c0dcb5422d3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208973
Listing Expiration 2026-12-31
Marketing Start 2017-06-15

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 701211395
Hyphenated Format 70121-1395

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 ANDA208973 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .4 mg/2mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (70121-1395-5) / 2 mL in 1 VIAL (70121-1395-1)
source: ndc

Packages (1)

70121-1395-5 25 VIAL in 1 CARTON (70121-1395-5) / 2 mL in 1 VIAL (70121-1395-1)

Ingredients (1)

glycopyrrolate (.4 mg/2mL)

Linked Drug Pages (1)

Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "eef9f866-2de4-4bc2-881d-c0dcb5422d3b", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["bbab4cf1-0441-4fc4-9de9-e4117fa19faa"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (70121-1395-5)  / 2 mL in 1 VIAL (70121-1395-1)", "package_ndc": "70121-1395-5", "marketing_start_date": "20170615"}], "brand_name": "Glycopyrrolate", "product_id": "70121-1395_eef9f866-2de4-4bc2-881d-c0dcb5422d3b", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70121-1395", "generic_name": "Glycopyrrolate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".4 mg/2mL"}], "application_number": "ANDA208973", "marketing_category": "ANDA", "marketing_start_date": "20170615", "listing_expiration_date": "20261231"}