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
7120583200
100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-00)
ndc11
7120583211
1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-11)
ndc11
7120583230
30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-30)
ndc11
7120583255
500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-55)
ndc11
7120583260
60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-60)
ndc11
7120583264
240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-64)
ndc11
7120583267
270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-67)
ndc11
7120583272
120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-72)
ndc11
7120583278
180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-78)
ndc11
7120583290
90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-90)

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": "71205-832_ea61ffd1-0610-4264-b964-00a9f4485d36",
  "productndc": "71205-832",
  "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

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