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United States · US · US:16571-743_9f8d9c4c-f326-4784-8ea4-f791613077f7

Glycopyrrolate

Orange BookUNIISPLATC A03AB02

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

Identification

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

Packs · 2

  • ndc11
    1657174303
    30 TABLET in 1 CONTAINER (16571-743-03)
  • ndc11
    1657174309
    90 TABLET in 1 CONTAINER (16571-743-09)

Annotations

UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
N012827
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": "16571-743_9f8d9c4c-f326-4784-8ea4-f791613077f7",
  "productndc": "16571-743",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "012827",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "Glycopyrrolate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA012827",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Glycopyrrolate",
  "start_marketing_date": "20201006",
  "active_numerator_strength": "1"
}

Related drugs

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