glycopyrrolate

Generic: glycopyrrolate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-743
Product ID 16571-743_9f8d9c4c-f326-4784-8ea4-f791613077f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA012827
Listing Expiration 2027-12-31
Marketing Start 2020-10-06

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 16571743
Hyphenated Format 16571-743

Supplemental Identifiers

RxCUI
197738 197739
UPC
0316571743094
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 NDA012827 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 CONTAINER (16571-743-03)
  • 90 TABLET in 1 CONTAINER (16571-743-09)
source: ndc

Packages (2)

16571-743-03 30 TABLET in 1 CONTAINER (16571-743-03) 16571-743-09 90 TABLET in 1 CONTAINER (16571-743-09)

Ingredients (1)

glycopyrrolate (1 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": "9f8d9c4c-f326-4784-8ea4-f791613077f7", "openfda": {"upc": ["0316571743094"], "unii": ["V92SO9WP2I"], "rxcui": ["197738", "197739"], "spl_set_id": ["58c4cb1f-59b8-4be9-a222-2264ca077d93"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 CONTAINER (16571-743-03)", "package_ndc": "16571-743-03", "marketing_start_date": "20201006"}, {"sample": false, "description": "90 TABLET in 1 CONTAINER (16571-743-09)", "package_ndc": "16571-743-09", "marketing_start_date": "20201006"}], "brand_name": "Glycopyrrolate", "product_id": "16571-743_9f8d9c4c-f326-4784-8ea4-f791613077f7", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16571-743", "generic_name": "Glycopyrrolate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/1"}], "application_number": "NDA012827", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20201006", "listing_expiration_date": "20271231"}