ez2go Laxative Bisacodyl

NDC product · U.S. Food and Drug Administration (openFDA) · United States

  • Product NDC 76470-059
  • Package NDC 76470-059-59
  • Application number 505G(a)(3)(A)
  • SPL ID 494cc23a-ef5b-26cd-e063-6294a90a4f15
  • SPL set ID e7bf28c4-58d9-4259-925c-16fbd45c66d3
  • UNII 10X0709Y6I

What the source publishes

Labeler
Valley Medical Products, LLC
Active ingredients
BISACODYL
Form
CAPSULE, COATED
Routes
ORAL
Administrative status
present-in-source-snapshot
Marketing status
OTC MONOGRAPH DRUG
Product type
HUMAN OTC DRUG
Prescription
Non-prescription

Names this record is found by

Complete source data
us:fda:ndc:76470-059_494cc23a-ef5b-26cd-e063-6294a90a4f15
{
  "name": "ez2go Laxative Bisacodyl",
  "splId": "494cc23a-ef5b-26cd-e063-6294a90a4f15",
  "labels": [
    {
      "setId": "e7bf28c4-58d9-4259-925c-16fbd45c66d3",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e7bf28c4-58d9-4259-925c-16fbd45c66d3",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=e7bf28c4-58d9-4259-925c-16fbd45c66d3"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "Valley Medical Products, LLC",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "4 CAPSULE, COATED in 1 BLISTER PACK (76470-059-59)",
      "package_ndc": "76470-059-59",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20251201"
    }
  ],
  "productId": "76470-059_494cc23a-ef5b-26cd-e063-6294a90a4f15",
  "useDomain": "unknown",
  "dosageForm": "CAPSULE, COATED",
  "productNdc": "76470-059",
  "deaSchedule": null,
  "genericName": "BISACODYL",
  "productType": "HUMAN OTC DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "BISACODYL",
      "strength": "5 mg/1"
    }
  ],
  "applicationNumber": "505G(a)(3)(A)",
  "marketingCategory": "OTC MONOGRAPH DRUG",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20251201",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "non-prescription",
  "harmonizedIdentifiers": {
    "nui": [
      "N0000009371",
      "N0000175812",
      "N0000009871"
    ],
    "unii": [
      "10X0709Y6I"
    ],
    "spl_set_id": [
      "e7bf28c4-58d9-4259-925c-16fbd45c66d3"
    ],
    "pharm_class_pe": [
      "Increased Large Intestinal Motility [PE]",
      "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
    ],
    "pharm_class_epc": [
      "Stimulant Laxative [EPC]"
    ],
    "manufacturer_name": [
      "Valley Medical Products, LLC"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20271231"
}

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