glycopyrrolate

Generic: glycopyrrolate

Labeler: aurolife pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler aurolife pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glycopyrrolate 2 mg/1

Manufacturer
Aurolife Pharma LLC

Identifiers & Regulatory

Product NDC 13107-015
Product ID 13107-015_1ec6c3c1-ed9c-481e-bcc0-bafb7f5c0448
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202675
Listing Expiration 2026-12-31
Marketing Start 2023-02-28

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 13107015
Hyphenated Format 13107-015

Supplemental Identifiers

RxCUI
197738 197739
UPC
0313107014017
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 ANDA202675 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-015-01)
source: ndc

Packages (1)

13107-015-01 100 TABLET in 1 BOTTLE (13107-015-01)

Ingredients (1)

glycopyrrolate (2 mg/1)

Linked Drug Pages (1)

GLYCOPYRROLATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ec6c3c1-ed9c-481e-bcc0-bafb7f5c0448", "openfda": {"upc": ["0313107014017"], "unii": ["V92SO9WP2I"], "rxcui": ["197738", "197739"], "spl_set_id": ["677f8495-a870-45b6-bb65-75b449f040ce"], "manufacturer_name": ["Aurolife Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-015-01)", "package_ndc": "13107-015-01", "marketing_start_date": "20230228"}], "brand_name": "GLYCOPYRROLATE", "product_id": "13107-015_1ec6c3c1-ed9c-481e-bcc0-bafb7f5c0448", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "13107-015", "generic_name": "GLYCOPYRROLATE", "labeler_name": "Aurolife Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYCOPYRROLATE", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "2 mg/1"}], "application_number": "ANDA202675", "marketing_category": "ANDA", "marketing_start_date": "20230228", "listing_expiration_date": "20261231"}