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United States · US · US:25021-796_13b1a856-788d-4154-a4b5-daa5a008cafa

Glycopyrrolate

Orange BookUNIISPLATC A03AB02

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

Identification

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

Packs · 3

  • ndc11
    2502179601
    10 VIAL in 1 CARTON (25021-796-01) / 1 mL in 1 VIAL
  • ndc11
    2502179602
    10 VIAL in 1 CARTON (25021-796-02) / 2 mL in 1 VIAL
  • ndc11
    2502179605
    10 VIAL in 1 CARTON (25021-796-05) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A210083
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
  "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": "25021-796_13b1a856-788d-4154-a4b5-daa5a008cafa",
  "productndc": "25021-796",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210083",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.2MG/ML",
        "product_no": "001",
        "approval_date": "Feb 21, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "Glycopyrrolate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210083",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glycopyrrolate",
  "start_marketing_date": "20241015",
  "active_numerator_strength": ".2"
}

Related drugs

Other records sharing ATC code A03AB02.

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