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 INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-013
Product ID 70069-013_1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211705
Listing Expiration 2026-12-31
Marketing Start 2022-01-29

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069013
Hyphenated Format 70069-013

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0370069011010 0370069012017 0370069013014 0370069014011
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 ANDA211705 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (70069-013-25) / 5 mL in 1 VIAL (70069-013-01)
source: ndc

Packages (1)

70069-013-25 25 VIAL in 1 CARTON (70069-013-25) / 5 mL in 1 VIAL (70069-013-01)

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": "1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9", "openfda": {"upc": ["0370069011010", "0370069012017", "0370069013014", "0370069014011"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (70069-013-25)  / 5 mL in 1 VIAL (70069-013-01)", "package_ndc": "70069-013-25", "marketing_start_date": "20220129"}], "brand_name": "Glycopyrrolate", "product_id": "70069-013_1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "70069-013", "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": "ANDA211705", "marketing_category": "ANDA", "marketing_start_date": "20220129", "listing_expiration_date": "20261231"}