sulindac

Generic: sulindac

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulindac
Generic Name sulindac
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulindac 200 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-374
Product ID 72789-374_31f654da-06fe-9e86-e063-6294a90a3312
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 72789374
Hyphenated Format 72789-374

Supplemental Identifiers

RxCUI
198239
UPC
0372789374826
UNII
184SNS8VUH
NUI
N0000000160 M0001335 N0000175722

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 (72789-374-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82)
source: ndc

Packages (2)

72789-374-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-374-01) 72789-374-82 500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82)

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": "31f654da-06fe-9e86-e063-6294a90a3312", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0372789374826"], "unii": ["184SNS8VUH"], "rxcui": ["198239"], "spl_set_id": ["1fffe88d-50c8-45cf-ac7c-a62b665c89a8"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72789-374-01)", "package_ndc": "72789-374-01", "marketing_start_date": "20240827"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82)", "package_ndc": "72789-374-82", "marketing_start_date": "20240125"}], "brand_name": "SULINDAC", "product_id": "72789-374_31f654da-06fe-9e86-e063-6294a90a3312", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72789-374", "generic_name": "sulindac", "labeler_name": "PD-Rx Pharmaceuticals, 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"}