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United States · US · US:50268-363_2f8b2a36-ac60-7762-e063-6294a90ae573

Glycopyrrolate

Orange BookUNIISPLATC A03AB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAvPAK
CountryUS (United States)
ATC codeA03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5026836315
    50 BLISTER PACK in 1 BOX (50268-363-15) / 1 TABLET in 1 BLISTER PACK (50268-363-11)

Annotations

UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A202675
AAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V92SO9WP2I",
    "rxcui": "4955",
    "inchikey": "VPNYRYCIDCJBOM-QQTWVUFVSA-M;VPNYRYCIDCJBOM-POCMBTLOSA-M",
    "display_name": "GLYCOPYRROLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ec15e70c-8473-469a-9f07-ea668783fa07": {
      "match": "brand_token",
      "title": "GLYCOPYRROLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "9",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50268-363_2f8b2a36-ac60-7762-e063-6294a90ae573",
  "productndc": "50268-363",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202675",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Apr 15, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "Glycopyrrolate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202675",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glycopyrrolate",
  "start_marketing_date": "20250304",
  "active_numerator_strength": "1"
}

Related drugs

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