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United States · US · US:80056-160_feae0733-6244-4791-b717-581bde769f02

Glycate

Orange BookUNIISPLATC A03AB02

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

Identification

ManufacturerIntra-Sana Laboratories
CountryUS (United States)
ATC codeA03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8005616010
    100 TABLET in 1 BOTTLE (80056-160-10)

Annotations

UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A091522
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": {
    "830ba1be-bef3-417c-a915-964cc6005b92": {
      "match": "brand_token",
      "title": "GLYCATE (GLYCOPYRROLATE) TABLET [INTRA-SANA LABORATORIES]",
      "spl_version": "4",
      "published_date": "2026-01-12"
    }
  },
  "productid": "80056-160_feae0733-6244-4791-b717-581bde769f02",
  "productndc": "80056-160",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091522",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Mar 12, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "Glycate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091522",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glycopyrrolate",
  "start_marketing_date": "20220401",
  "active_numerator_strength": "1.5"
}

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