glycopyrrolate

Generic: glycopyrrolate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-961
Product ID 62135-961_32fec6b3-f126-b5b6-e063-6394a90ab77d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216368
Listing Expiration 2026-12-31
Marketing Start 2024-08-28

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 62135961
Hyphenated Format 62135-961

Supplemental Identifiers

RxCUI
999961
UPC
0362135961473
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 ANDA216368 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (62135-961-47)
source: ndc

Packages (1)

62135-961-47 473 mL in 1 BOTTLE (62135-961-47)

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": "32fec6b3-f126-b5b6-e063-6394a90ab77d", "openfda": {"upc": ["0362135961473"], "unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["89090b34-470c-478c-be49-1d2bc48a28f8"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (62135-961-47)", "package_ndc": "62135-961-47", "marketing_start_date": "20250411"}], "brand_name": "Glycopyrrolate", "product_id": "62135-961_32fec6b3-f126-b5b6-e063-6394a90ab77d", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "62135-961", "generic_name": "Glycopyrrolate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA216368", "marketing_category": "ANDA", "marketing_start_date": "20240828", "listing_expiration_date": "20261231"}