glycopyrrolate oral solution (51672-5316)

Drug Facts

Product Profile

Brand Name glycopyrrolate oral solution

Generic Name glycopyrrolate oral solution

Labeler taro pharmaceuticals u.s.a. inc.

Dosage Form LIQUID

Routes

ORAL

Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer

Taro Pharmaceuticals U.S.A. Inc.

Identifiers & Regulatory

Product NDC 51672-5316

Product ID 51672-5316_0e8fd624-fbe2-c134-e063-6294a90a01e2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212467

Listing Expiration 2026-12-31

Marketing Start 2022-07-05

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 516725316

Hyphenated Format 51672-5316

Supplemental Identifiers

RxCUI

999961

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 oral solution (source: ndc)

Application Number ANDA212467 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (51672-5316-9) / 500 mL in 1 BOTTLE

source: ndc

Packages (1)

51672-5316-9 1 BOTTLE in 1 CARTON (51672-5316-9) / 500 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": "0e8fd624-fbe2-c134-e063-6294a90a01e2", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["999961"], "spl_set_id": ["e20c9a89-2a81-3c6e-e053-2995a90a9861"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A. Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-5316-9)  / 500 mL in 1 BOTTLE", "package_ndc": "51672-5316-9", "marketing_start_date": "20220705"}], "brand_name": "Glycopyrrolate Oral Solution", "product_id": "51672-5316_0e8fd624-fbe2-c134-e063-6294a90a01e2", "dosage_form": "LIQUID", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "51672-5316", "generic_name": "Glycopyrrolate Oral Solution", "labeler_name": "Taro Pharmaceuticals U.S.A. Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate Oral Solution", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA212467", "marketing_category": "ANDA", "marketing_start_date": "20220705", "listing_expiration_date": "20261231"}