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 63323-578
Product ID 63323-578_779dc924-ecc3-41cc-8cf9-a7354db4f763
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209328
Listing Expiration 2026-12-31
Marketing Start 2017-10-27

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323578
Hyphenated Format 63323-578

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0363323578046 0363323578039 0363323578077
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 ANDA209328 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04)
  • 25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07)
source: ndc

Packages (3)

63323-578-01 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03) 63323-578-02 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04) 63323-578-05 25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07)

Ingredients (1)

glycopyrrolate (.2 mg/mL)

Linked Drug Pages (2)

Glycopyrrolate ndc-match (0.9) Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "779dc924-ecc3-41cc-8cf9-a7354db4f763", "openfda": {"upc": ["0363323578046", "0363323578039", "0363323578077"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["54458620-d888-4df6-ae4b-78c3dfed3423"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03)", "package_ndc": "63323-578-01", "marketing_start_date": "20171027"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04)", "package_ndc": "63323-578-02", "marketing_start_date": "20171027"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05)  / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07)", "package_ndc": "63323-578-05", "marketing_start_date": "20171027"}], "brand_name": "Glycopyrrolate", "product_id": "63323-578_779dc924-ecc3-41cc-8cf9-a7354db4f763", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "63323-578", "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": "ANDA209328", "marketing_category": "ANDA", "marketing_start_date": "20171027", "listing_expiration_date": "20261231"}