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
7120583100
100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-00)
ndc11
7120583111
1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11)
ndc11
7120583130
30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30)
ndc11
7120583155
500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55)
ndc11
7120583160
60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60)
ndc11
7120583164
240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64)
ndc11
7120583167
270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-67)
ndc11
7120583172
120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-72)
ndc11
7120583178
180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-78)
ndc11
7120583190
90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-90)

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": "71205-831_4aed57d0-99d8-424e-a1c7-0cd8a31a66cf",
  "productndc": "71205-831",
  "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": "8"
}

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