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United States · US · US:0591-5660_988f11c7-805d-4926-84b3-4c9c0cb0038d

Sulindac

Orange BookUNIISPLATC M01AB02

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeM01AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0591566001
    100 TABLET in 1 BOTTLE, PLASTIC (0591-5660-01)
  • ndc11
    0591566005
    500 TABLET in 1 BOTTLE, PLASTIC (0591-5660-05)

Annotations

UNII (FDA Substance ID)
184SNS8VUH
SULINDAC
RxCUI 10237
Orange Book
A071795
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "184SNS8VUH",
    "rxcui": "10237",
    "inchikey": "MLKXDPUZXIRXEP-MFOYZWKCSA-N",
    "display_name": "SULINDAC",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6041acc2-5e8a-4d3c-bf50-7e9447748e2b": {
      "match": "brand_token",
      "title": "SULINDAC TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "16",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0591-5660_988f11c7-805d-4926-84b3-4c9c0cb0038d",
  "productndc": "0591-5660",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071795",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Apr 3, 1990"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULINDAC",
  "proprietary_name": "Sulindac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA071795",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulindac",
  "start_marketing_date": "19900403",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code M01AB02.

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