GaviLyte-H and Bisacodyl

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4338607183
1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17)

Annotations

Orange Book

A202217

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "78fe1c29-e22a-4615-a2f9-a61cd4eb38a3": {
      "match": "brand_token",
      "title": "GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-01-30"
    }
  },
  "productid": "43386-071_c34cfe17-96c2-4f07-8a2d-74bc84e61fb4",
  "productndc": "43386-071",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202217",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM",
        "product_no": "001",
        "approval_date": "Aug 20, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "GaviLyte-H and Bisacodyl",
  "active_ingred_unit": null,
  "application_number": "ANDA202217",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release Tablet",
  "start_marketing_date": "20150421",
  "active_numerator_strength": null
}

Access this data programmatically

Query GaviLyte-H and Bisacodyl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs