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United States · US · US:53489-479_2524fd49-5789-e388-e063-6394a90a2c9b

SULINDAC

Orange BookUNIISPLATC M01AB02

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

Identification

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

Packs · 6

  • ndc11
    5348947901
    100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01)
  • ndc11
    5348947902
    50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02)
  • ndc11
    5348947903
    250 TABLET in 1 BOTTLE, PLASTIC (53489-479-03)
  • ndc11
    5348947905
    500 TABLET in 1 BOTTLE, PLASTIC (53489-479-05)
  • ndc11
    5348947906
    60 TABLET in 1 BOTTLE, PLASTIC (53489-479-06)
  • ndc11
    5348947910
    1000 TABLET in 1 BOTTLE, PLASTIC (53489-479-10)

Annotations

UNII (FDA Substance ID)
184SNS8VUH
SULINDAC
RxCUI 10237
Orange Book
A072051
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": "53489-479_2524fd49-5789-e388-e063-6394a90a2c9b",
  "productndc": "53489-479",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "072051",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Apr 17, 1991"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULINDAC",
  "proprietary_name": "SULINDAC",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072051",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sulindac",
  "start_marketing_date": "20090904",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code M01AB02.

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