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United States · US · US:49884-065_1b923cd6-6a35-4f2f-bcb8-cab438977a08

Glycopyrrolate

Orange BookUNIISPLATC A03AB02

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeA03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4988406501
    100 TABLET in 1 BOTTLE (49884-065-01)

Annotations

UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A040653
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": "49884-065_1b923cd6-6a35-4f2f-bcb8-cab438977a08",
  "productndc": "49884-065",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040653",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 31, 2006"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 31, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "Glycopyrrolate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040653",
  "marketing_category": "ANDA",
  "nonproprietary_name": "glycopyrrolate",
  "start_marketing_date": "20060926",
  "active_numerator_strength": "1"
}

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