glycopyrrolate

Generic: glycopyrrolate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-203
Product ID 76045-203_d8f5e3e4-34e3-4e52-b76d-69e210e649d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209024
Listing Expiration 2026-12-31
Marketing Start 2018-07-25

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045203
Hyphenated Format 76045-203

Supplemental Identifiers

RxCUI
2101490 2101495
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 ANDA209024 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-203-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01) / 1 mL in 1 SYRINGE, GLASS
  • 24 BLISTER PACK in 1 CARTON (76045-203-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02) / 2 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

76045-203-10 24 BLISTER PACK in 1 CARTON (76045-203-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01) / 1 mL in 1 SYRINGE, GLASS 76045-203-20 24 BLISTER PACK in 1 CARTON (76045-203-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02) / 2 mL in 1 SYRINGE, GLASS

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": "d8f5e3e4-34e3-4e52-b76d-69e210e649d5", "openfda": {"unii": ["V92SO9WP2I"], "rxcui": ["2101490", "2101495"], "spl_set_id": ["88d3e865-8dca-4c89-b6f7-a34c481f75b9"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-203-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-203-10", "marketing_start_date": "20180725"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-203-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02)  / 2 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-203-20", "marketing_start_date": "20180725"}], "brand_name": "Glycopyrrolate", "product_id": "76045-203_d8f5e3e4-34e3-4e52-b76d-69e210e649d5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "76045-203", "generic_name": "Glycopyrrolate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA209024", "marketing_category": "ANDA", "marketing_start_date": "20180725", "listing_expiration_date": "20261231"}