Lubiprostone

Orange BookUNIISPLATC A06AX03

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA06AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7120583400
100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-00)
ndc11
7120583411
1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-11)
ndc11
7120583430
30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-30)
ndc11
7120583455
500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-55)
ndc11
7120583460
60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-60)
ndc11
7120583464
240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-64)
ndc11
7120583467
270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-67)
ndc11
7120583472
120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-72)
ndc11
7120583478
180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-78)
ndc11
7120583490
90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-90)

Annotations

UNII (FDA Substance ID)

7662KG2R6K

LUBIPROSTONE

RxCUI 623033

Orange Book

N021908

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": "71205-834_a368117c-0e80-4dbc-a0a7-9b88dbfeece3",
  "productndc": "71205-834",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "021908",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "24MCG",
        "product_no": "001",
        "approval_date": "Jan 31, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "8MCG",
        "product_no": "002",
        "approval_date": "Apr 29, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LUBIPROSTONE",
  "proprietary_name": "Lubiprostone",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021908",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Lubiprostone",
  "start_marketing_date": "20230101",
  "active_numerator_strength": "24"
}

Related drugs

Other records sharing ATC code A06AX03.

Access this data programmatically

Query Lubiprostone 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