glycopyrrolate

Generic: glycopyrrolate

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

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-616
Product ID 70069-616_2fc11e36-103a-4967-9130-89ab02d9a1f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207639
Listing Expiration 2026-12-31
Marketing Start 2022-02-18

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 70069616
Hyphenated Format 70069-616

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0370069616017 0370069619018 0370069617014 0370069618257 0370069617250 0370069618011 0370069619254 0370069616109
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 ANDA207639 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (70069-616-10) / 20 mL in 1 VIAL (70069-616-01)
source: ndc

Packages (1)

70069-616-10 10 VIAL in 1 CARTON (70069-616-10) / 20 mL in 1 VIAL (70069-616-01)

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": "2fc11e36-103a-4967-9130-89ab02d9a1f0", "openfda": {"upc": ["0370069616017", "0370069619018", "0370069617014", "0370069618257", "0370069617250", "0370069618011", "0370069619254", "0370069616109"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["48cfbd5a-b133-4720-9bd7-65296064ea3c"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70069-616-10)  / 20 mL in 1 VIAL (70069-616-01)", "package_ndc": "70069-616-10", "marketing_start_date": "20220218"}], "brand_name": "GLYCOPYRROLATE", "product_id": "70069-616_2fc11e36-103a-4967-9130-89ab02d9a1f0", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70069-616", "generic_name": "GLYCOPYRROLATE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYCOPYRROLATE", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA207639", "marketing_category": "ANDA", "marketing_start_date": "20220218", "listing_expiration_date": "20261231"}