GLYRX-PF

Orange BookUNIISPLATC A03AB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerExela Pharma Sciences, LLC

CountryUS (United States)

ATC codeA03AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5175460153
10 SYRINGE, PLASTIC in 1 CARTON (51754-6015-3) / 5 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)

V92SO9WP2I

GLYCOPYRROLATE

RxCUI 4955

Orange Book

N210997

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": {
    "2189f3f5-39dc-4e85-b7c6-9515ded59686": {
      "match": "brand_token",
      "title": "GLYRX-PF (GLYCOPYRROLATE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]",
      "spl_version": "5",
      "published_date": "2025-07-25"
    }
  },
  "productid": "51754-6015_442634f7-9858-421d-91db-5bfdb21dcf13",
  "productndc": "51754-6015",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210997",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/ML (0.2MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 11, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG/2ML (0.2MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 11, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/5ML (0.2MG/ML)",
        "product_no": "003",
        "approval_date": "Apr 9, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.6MG/3ML (0.2MG/ML)",
        "product_no": "004",
        "approval_date": "Dec 14, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "GLYRX-PF",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA210997",
  "marketing_category": "NDA",
  "nonproprietary_name": "glycopyrrolate",
  "start_marketing_date": "20200601",
  "active_numerator_strength": ".2"
}

Related drugs

Other records sharing ATC code A03AB02.

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