glycopyrrolate

Generic: glycopyrrolate

Labeler: accord healthcare, inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler accord healthcare, inc.,
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Accord Healthcare, Inc.,

Identifiers & Regulatory

Product NDC 16729-473
Product ID 16729-473_415de5a5-d773-4816-e063-6294a90a6853
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213238
Listing Expiration 2026-12-31
Marketing Start 2020-12-10

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 16729473
Hyphenated Format 16729-473

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0316729474054 0316729472302 0316729473316 0316729471633
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 ANDA213238 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (16729-473-03) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

16729-473-03 10 VIAL, MULTI-DOSE in 1 CARTON (16729-473-03) / 5 mL in 1 VIAL, MULTI-DOSE

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": "415de5a5-d773-4816-e063-6294a90a6853", "openfda": {"upc": ["0316729474054", "0316729472302", "0316729473316", "0316729471633"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["871797f0-697a-4a29-a37b-d06219e8f266"], "manufacturer_name": ["Accord Healthcare, Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (16729-473-03)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-473-03", "marketing_start_date": "20201217"}], "brand_name": "Glycopyrrolate", "product_id": "16729-473_415de5a5-d773-4816-e063-6294a90a6853", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16729-473", "generic_name": "glycopyrrolate", "labeler_name": "Accord Healthcare, Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA213238", "marketing_category": "ANDA", "marketing_start_date": "20201210", "listing_expiration_date": "20261231"}