glycopyrrolate oral solution

Generic: glycopyrrolate

Labeler: ajenat pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate oral solution
Generic Name glycopyrrolate
Labeler ajenat pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
AJENAT PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 82983-428
Product ID 82983-428_80036e14-8ef8-4d3e-a6c5-4bfca592dd79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219267
Listing Expiration 2026-12-31
Marketing Start 2025-12-12

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 82983428
Hyphenated Format 82983-428

Supplemental Identifiers

RxCUI
999961
UPC
0382983428478
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 oral solution (source: ndc)
Generic Name glycopyrrolate (source: ndc)
Application Number ANDA219267 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOTTLE (82983-428-47) / 473 mL in 1 BOTTLE
source: ndc

Packages (1)

82983-428-47 1 BOTTLE in 1 BOTTLE (82983-428-47) / 473 mL in 1 BOTTLE

Ingredients (1)

glycopyrrolate (1 mg/5mL)

Linked Drug Pages (1)

Glycopyrrolate Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "80036e14-8ef8-4d3e-a6c5-4bfca592dd79", "openfda": {"upc": ["0382983428478"], "unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["7049feaf-004a-481f-b129-996b21c3170a"], "manufacturer_name": ["AJENAT PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOTTLE (82983-428-47)  / 473 mL in 1 BOTTLE", "package_ndc": "82983-428-47", "marketing_start_date": "20251212"}], "brand_name": "Glycopyrrolate Oral Solution", "product_id": "82983-428_80036e14-8ef8-4d3e-a6c5-4bfca592dd79", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "82983-428", "generic_name": "Glycopyrrolate", "labeler_name": "AJENAT PHARMACEUTICALS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate Oral Solution", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA219267", "marketing_category": "ANDA", "marketing_start_date": "20251212", "listing_expiration_date": "20261231"}