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United States · US · US:70710-1641_f06e99fa-9894-48ab-99d8-914987dbb73f

Lubiprostone

Orange BookUNIISPLATC A06AX03

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA06AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7071016411
    100 CAPSULE in 1 BOTTLE (70710-1641-1)
  • ndc11
    7071016416
    60 CAPSULE in 1 BOTTLE (70710-1641-6)

Annotations

UNII (FDA Substance ID)
7662KG2R6K
LUBIPROSTONE
RxCUI 623033
Orange Book
A214131
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7662KG2R6K",
    "rxcui": "623033",
    "inchikey": "WGFOBBZOWHGYQH-MXHNKVEKSA-N",
    "display_name": "LUBIPROSTONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f4d506e0-1322-4fc4-e053-2995a90ac880": {
      "match": "brand_token",
      "title": "LUBIPROSTONE CAPSULE, GELATIN COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "5",
      "published_date": "2026-05-11"
    }
  },
  "productid": "70710-1641_f06e99fa-9894-48ab-99d8-914987dbb73f",
  "productndc": "70710-1641",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214131",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MCG",
        "product_no": "001",
        "approval_date": "Mar 23, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "24MCG",
        "product_no": "002",
        "approval_date": "Mar 23, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LUBIPROSTONE",
  "proprietary_name": "Lubiprostone",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA214131",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lubiprostone",
  "start_marketing_date": "20230323",
  "active_numerator_strength": "8"
}

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