glycopyrrolate

Generic: glycopyrrolate

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler solco healthcare us, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-639
Product ID 43547-639_8a403c54-3e23-41fc-bf80-c40e8d867aa2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210927
Listing Expiration 2027-12-31
Marketing Start 2019-03-20

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 43547639
Hyphenated Format 43547-639

Supplemental Identifiers

RxCUI
1731582 1731590
UPC
0343547639013 0343547640019
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 ANDA210927 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (43547-639-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43547-639-01)
source: ndc

Packages (1)

43547-639-25 25 VIAL, SINGLE-DOSE in 1 CARTON (43547-639-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43547-639-01)

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": "8a403c54-3e23-41fc-bf80-c40e8d867aa2", "openfda": {"upc": ["0343547639013", "0343547640019"], "unii": ["V92SO9WP2I"], "rxcui": ["1731582", "1731590"], "spl_set_id": ["2972f22e-378c-450b-8869-1354a9bd0ffc"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (43547-639-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (43547-639-01)", "package_ndc": "43547-639-25", "marketing_start_date": "20210501"}], "brand_name": "GLYCOPYRROLATE", "product_id": "43547-639_8a403c54-3e23-41fc-bf80-c40e8d867aa2", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43547-639", "generic_name": "glycopyrrolate", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYCOPYRROLATE", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA210927", "marketing_category": "ANDA", "marketing_start_date": "20190320", "listing_expiration_date": "20271231"}