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United States · US · US:70069-013_1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9

Glycopyrrolate

Orange BookUNIISPLATC A03AB02

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

Identification

ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeA03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7006901325
    25 VIAL in 1 CARTON (70069-013-25) / 5 mL in 1 VIAL (70069-013-01)

Annotations

UNII (FDA Substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A211705
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": "70069-013_1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9",
  "productndc": "70069-013",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "211705",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.2MG/ML",
        "product_no": "001",
        "approval_date": "Mar 20, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "Glycopyrrolate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA211705",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glycopyrrolate",
  "start_marketing_date": "20220129",
  "active_numerator_strength": ".2"
}

Related drugs

Other records sharing ATC code A03AB02.

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