glycopyrrolate

Generic: glycopyrrolate

Labeler: auromedics pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler auromedics pharma llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate .2 mg/mL

Manufacturer
AuroMedics Pharma LLC

Identifiers & Regulatory

Product NDC 55150-293
Product ID 55150-293_eea49fec-ee88-4ac2-bc4f-5ff7a7b1bbda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210244
Listing Expiration 2026-12-31
Marketing Start 2018-11-28

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150293
Hyphenated Format 55150-293

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0355150295203
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 ANDA210244 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-293-02) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-293-02 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-293-02) / 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": "eea49fec-ee88-4ac2-bc4f-5ff7a7b1bbda", "openfda": {"upc": ["0355150295203"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["eaebb511-1738-4d11-b9bb-317a8d41316a"], "manufacturer_name": ["AuroMedics Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-293-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-293-02", "marketing_start_date": "20181128"}], "brand_name": "Glycopyrrolate", "product_id": "55150-293_eea49fec-ee88-4ac2-bc4f-5ff7a7b1bbda", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "55150-293", "generic_name": "Glycopyrrolate", "labeler_name": "AuroMedics Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": ".2 mg/mL"}], "application_number": "ANDA210244", "marketing_category": "ANDA", "marketing_start_date": "20181128", "listing_expiration_date": "20261231"}