sulindac

Generic: sulindac

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulindac
Generic Name sulindac
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulindac 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-479
Product ID 53489-479_2524fd49-5789-e388-e063-6394a90a2c9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072051
Listing Expiration 2026-12-31
Marketing Start 2009-09-04

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53489479
Hyphenated Format 53489-479

Supplemental Identifiers

RxCUI
198238 198239
UPC
0353489479011 0353489478014
UNII
184SNS8VUH
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sulindac (source: ndc)
Generic Name sulindac (source: ndc)
Application Number ANDA072051 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01)
  • 50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02)
  • 250 TABLET in 1 BOTTLE, PLASTIC (53489-479-03)
  • 500 TABLET in 1 BOTTLE, PLASTIC (53489-479-05)
  • 60 TABLET in 1 BOTTLE, PLASTIC (53489-479-06)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (53489-479-10)
source: ndc

Packages (6)

53489-479-01 100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01) 53489-479-02 50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02) 53489-479-03 250 TABLET in 1 BOTTLE, PLASTIC (53489-479-03) 53489-479-05 500 TABLET in 1 BOTTLE, PLASTIC (53489-479-05) 53489-479-06 60 TABLET in 1 BOTTLE, PLASTIC (53489-479-06) 53489-479-10 1000 TABLET in 1 BOTTLE, PLASTIC (53489-479-10)

Ingredients (1)

sulindac (200 mg/1)

Linked Drug Pages (1)

SULINDAC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2524fd49-5789-e388-e063-6394a90a2c9b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0353489479011", "0353489478014"], "unii": ["184SNS8VUH"], "rxcui": ["198238", "198239"], "spl_set_id": ["a47e4259-d44b-4b7b-b517-841cb6840982"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01)", "package_ndc": "53489-479-01", "marketing_start_date": "20090904"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02)", "package_ndc": "53489-479-02", "marketing_start_date": "20090904"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE, PLASTIC (53489-479-03)", "package_ndc": "53489-479-03", "marketing_start_date": "20090904"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (53489-479-05)", "package_ndc": "53489-479-05", "marketing_start_date": "20090904"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (53489-479-06)", "package_ndc": "53489-479-06", "marketing_start_date": "20090904"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (53489-479-10)", "package_ndc": "53489-479-10", "marketing_start_date": "20090904"}], "brand_name": "SULINDAC", "product_id": "53489-479_2524fd49-5789-e388-e063-6394a90a2c9b", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53489-479", "generic_name": "sulindac", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SULINDAC", "active_ingredients": [{"name": "SULINDAC", "strength": "200 mg/1"}], "application_number": "ANDA072051", "marketing_category": "ANDA", "marketing_start_date": "20090904", "listing_expiration_date": "20261231"}