glycopyrrolate

Generic: glycopyrrolate

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

Drug Facts

Product Profile

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

glycopyrrolate .2 mg/mL

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-194
Product ID 75834-194_29803114-1d00-4e06-9a14-b75895c85f5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212591
Listing Expiration 2026-12-31
Marketing Start 2021-10-25

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834194
Hyphenated Format 75834-194

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0375834196107 0375834193250 0375834194257 0375834195254
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 ANDA212591 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (75834-194-25) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

75834-194-25 25 VIAL, SINGLE-DOSE in 1 CARTON (75834-194-25) / 2 mL in 1 VIAL, SINGLE-DOSE

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": "29803114-1d00-4e06-9a14-b75895c85f5a", "openfda": {"upc": ["0375834196107", "0375834193250", "0375834194257", "0375834195254"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (75834-194-25)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "75834-194-25", "marketing_start_date": "20211025"}], "brand_name": "GLYCOPYRROLATE", "product_id": "75834-194_29803114-1d00-4e06-9a14-b75895c85f5a", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "75834-194", "generic_name": "glycopyrrolate", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYCOPYRROLATE", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA212591", "marketing_category": "ANDA", "marketing_start_date": "20211025", "listing_expiration_date": "20261231"}