glycopyrrolate

Generic: glycopyrrolate

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-415
Product ID 71288-415_b3bf6c1b-89c3-44ad-b505-9f2384e15a9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212802
Listing Expiration 2026-12-31
Marketing Start 2021-07-06

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 71288415
Hyphenated Format 71288-415

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 ANDA212802 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05)
  • 10 VIAL, MULTI-DOSE in 1 CARTON (71288-415-21) / 20 mL in 1 VIAL, MULTI-DOSE (71288-415-20)
source: ndc

Packages (2)

71288-415-06 25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05) 71288-415-21 10 VIAL, MULTI-DOSE in 1 CARTON (71288-415-21) / 20 mL in 1 VIAL, MULTI-DOSE (71288-415-20)

Ingredients (1)

glycopyrrolate (.2 mg/mL)

Linked Drug Pages (2)

Glycopyrrolate ndc-match (0.9) Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "b3bf6c1b-89c3-44ad-b505-9f2384e15a9b", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["02541cfd-b209-49b9-a73f-13ef18dce06d"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-415-06)  / 5 mL in 1 VIAL, MULTI-DOSE (71288-415-05)", "package_ndc": "71288-415-06", "marketing_start_date": "20210706"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (71288-415-21)  / 20 mL in 1 VIAL, MULTI-DOSE (71288-415-20)", "package_ndc": "71288-415-21", "marketing_start_date": "20210706"}], "brand_name": "Glycopyrrolate", "product_id": "71288-415_b3bf6c1b-89c3-44ad-b505-9f2384e15a9b", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "71288-415", "generic_name": "Glycopyrrolate", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA212802", "marketing_category": "ANDA", "marketing_start_date": "20210706", "listing_expiration_date": "20261231"}