glycopyrrolate

Generic: glycopyrrolate

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

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler be pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
BE Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71839-123
Product ID 71839-123_d9df3900-a8c2-438b-8971-ba11ff91f90b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211705
Listing Expiration 2026-12-31
Marketing Start 2022-03-10

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71839123
Hyphenated Format 71839-123

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0371839126019
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 ANDA211705 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (71839-123-25) / 1 mL in 1 VIAL, SINGLE-DOSE (71839-123-01)
source: ndc

Packages (1)

71839-123-25 25 VIAL, SINGLE-DOSE in 1 CARTON (71839-123-25) / 1 mL in 1 VIAL, SINGLE-DOSE (71839-123-01)

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": "d9df3900-a8c2-438b-8971-ba11ff91f90b", "openfda": {"upc": ["0371839126019"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["d9df3900-a8c2-438b-8971-ba11ff91f90b"], "manufacturer_name": ["BE Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (71839-123-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (71839-123-01)", "package_ndc": "71839-123-25", "marketing_start_date": "20220310"}], "brand_name": "glycopyrrolate", "product_id": "71839-123_d9df3900-a8c2-438b-8971-ba11ff91f90b", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "71839-123", "generic_name": "glycopyrrolate", "labeler_name": "BE Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA211705", "marketing_category": "ANDA", "marketing_start_date": "20220310", "listing_expiration_date": "20261231"}