glycopyrrolate

Generic: glycopyrrolate

Labeler: alembic labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler alembic labs llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glycopyrrolate 1 mg/1

Manufacturer
Alembic Labs LLC

Identifiers & Regulatory

Product NDC 15955-305
Product ID 15955-305_adf69aaa-e03b-419a-ac5b-e7b80cab3668
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203657
Listing Expiration 2026-12-31
Marketing Start 2012-10-19

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 15955305
Hyphenated Format 15955-305

Supplemental Identifiers

RxCUI
197738 197739
UPC
0315955318019 0315955305019
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 ANDA203657 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (15955-305-01)
source: ndc

Packages (1)

15955-305-01 100 TABLET in 1 BOTTLE, PLASTIC (15955-305-01)

Ingredients (1)

glycopyrrolate (1 mg/1)

Linked Drug Pages (1)

GLYCOPYRROLATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "adf69aaa-e03b-419a-ac5b-e7b80cab3668", "openfda": {"upc": ["0315955318019", "0315955305019"], "unii": ["V92SO9WP2I"], "rxcui": ["197738", "197739"], "spl_set_id": ["db178372-51d2-4194-bbe2-da9acb1cfd53"], "manufacturer_name": ["Alembic Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (15955-305-01)", "package_ndc": "15955-305-01", "marketing_start_date": "20121019"}], "brand_name": "GLYCOPYRROLATE", "product_id": "15955-305_adf69aaa-e03b-419a-ac5b-e7b80cab3668", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "15955-305", "generic_name": "GLYCOPYRROLATE", "labeler_name": "Alembic Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLYCOPYRROLATE", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/1"}], "application_number": "ANDA203657", "marketing_category": "ANDA", "marketing_start_date": "20121019", "listing_expiration_date": "20261231"}