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
{
"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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