glycopyrrolate

Generic: glycopyrrolate

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler camber pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-016
Product ID 31722-016_e3b10753-2b28-5dd9-e053-2995a90a8687
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213698
Listing Expiration 2026-12-31
Marketing Start 2022-07-05

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722016
Hyphenated Format 31722-016

Supplemental Identifiers

RxCUI
999961
UPC
0331722016476
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 ANDA213698 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (31722-016-47) / 473 mL in 1 BOTTLE
source: ndc

Packages (1)

31722-016-47 1 BOTTLE in 1 CARTON (31722-016-47) / 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": "e3b10753-2b28-5dd9-e053-2995a90a8687", "openfda": {"upc": ["0331722016476"], "unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["4741be85-3abb-4545-aba9-281f64d210ec"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (31722-016-47)  / 473 mL in 1 BOTTLE", "package_ndc": "31722-016-47", "marketing_start_date": "20220705"}], "brand_name": "Glycopyrrolate", "product_id": "31722-016_e3b10753-2b28-5dd9-e053-2995a90a8687", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "31722-016", "generic_name": "Glycopyrrolate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA213698", "marketing_category": "ANDA", "marketing_start_date": "20220705", "listing_expiration_date": "20261231"}