glycopyrrolate

Generic: glycopyrrolate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-796
Product ID 25021-796_dd91a731-1472-4b4b-8654-5acd3571cf3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210083
Listing Expiration 2026-12-31
Marketing Start 2024-10-15

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 25021796
Hyphenated Format 25021-796

Supplemental Identifiers

RxCUI
238212 1731582 1731590
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 ANDA210083 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-796-01) / 1 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-796-02) / 2 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-796-05) / 5 mL in 1 VIAL
source: ndc

Packages (3)

25021-796-01 10 VIAL in 1 CARTON (25021-796-01) / 1 mL in 1 VIAL 25021-796-02 10 VIAL in 1 CARTON (25021-796-02) / 2 mL in 1 VIAL 25021-796-05 10 VIAL in 1 CARTON (25021-796-05) / 5 mL in 1 VIAL

Ingredients (1)

glycopyrrolate (.2 mg/mL)

Linked Drug Pages (1)

Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "dd91a731-1472-4b4b-8654-5acd3571cf3c", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["55930f87-8964-43b1-b790-c1e6dd2602d2"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-796-01)  / 1 mL in 1 VIAL", "package_ndc": "25021-796-01", "marketing_start_date": "20241015"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-796-02)  / 2 mL in 1 VIAL", "package_ndc": "25021-796-02", "marketing_start_date": "20241115"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-796-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-796-05", "marketing_start_date": "20241115"}], "brand_name": "Glycopyrrolate", "product_id": "25021-796_dd91a731-1472-4b4b-8654-5acd3571cf3c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "25021-796", "generic_name": "Glycopyrrolate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA210083", "marketing_category": "ANDA", "marketing_start_date": "20241015", "listing_expiration_date": "20261231"}