glycopyrrolate

Generic: glycopyrrolate

Labeler: saptalis pharmaceuticals, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler saptalis pharmaceuticals, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Saptalis Pharmaceuticals, LLC.

Identifiers & Regulatory

Product NDC 71656-061
Product ID 71656-061_26be665a-acae-22fd-e063-6394a90a2a0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216297
Listing Expiration 2026-12-31
Marketing Start 2024-11-25

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 71656061
Hyphenated Format 71656-061

Supplemental Identifiers

RxCUI
999961
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 ANDA216297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOTTLE (71656-061-16) / 473 mL in 1 BOTTLE
source: ndc

Packages (1)

71656-061-16 1 BOTTLE in 1 BOTTLE (71656-061-16) / 473 mL in 1 BOTTLE

Ingredients (1)

glycopyrrolate (1 mg/5mL)

Linked Drug Pages (1)

glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26be665a-acae-22fd-e063-6394a90a2a0e", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["3e6f8091-d6fe-4c8f-b897-606a70bf74bc"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOTTLE (71656-061-16)  / 473 mL in 1 BOTTLE", "package_ndc": "71656-061-16", "marketing_start_date": "20241125"}], "brand_name": "glycopyrrolate", "product_id": "71656-061_26be665a-acae-22fd-e063-6394a90a2a0e", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "71656-061", "generic_name": "glycopyrrolate", "labeler_name": "Saptalis Pharmaceuticals, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA216297", "marketing_category": "ANDA", "marketing_start_date": "20241125", "listing_expiration_date": "20261231"}