etodolac

Generic: etodolac

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

etodolac 400 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8673
Product ID 68788-8673_fe4239d0-8003-4b3e-9770-01b21a0dd1d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075074
Listing Expiration 2026-12-31
Marketing Start 2024-05-22

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 687888673
Hyphenated Format 68788-8673

Supplemental Identifiers

RxCUI
197686
UNII
2M36281008
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 etodolac (source: ndc)
Generic Name etodolac (source: ndc)
Application Number ANDA075074 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8673-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8673-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8673-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8673-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8673-9)
source: ndc

Packages (5)

68788-8673-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8673-1) 68788-8673-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8673-2) 68788-8673-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8673-3) 68788-8673-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8673-6) 68788-8673-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8673-9)

Ingredients (1)

etodolac (400 mg/1)

Linked Drug Pages (1)

Etodolac ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe4239d0-8003-4b3e-9770-01b21a0dd1d8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["197686"], "spl_set_id": ["117b3005-a8ec-4f76-824c-95ec42dc87a1"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8673-1)", "package_ndc": "68788-8673-1", "marketing_start_date": "20240522"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8673-2)", "package_ndc": "68788-8673-2", "marketing_start_date": "20240522"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8673-3)", "package_ndc": "68788-8673-3", "marketing_start_date": "20240522"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8673-6)", "package_ndc": "68788-8673-6", "marketing_start_date": "20240522"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8673-9)", "package_ndc": "68788-8673-9", "marketing_start_date": "20240522"}], "brand_name": "Etodolac", "product_id": "68788-8673_fe4239d0-8003-4b3e-9770-01b21a0dd1d8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-8673", "generic_name": "Etodolac", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "400 mg/1"}], "application_number": "ANDA075074", "marketing_category": "ANDA", "marketing_start_date": "20240522", "listing_expiration_date": "20261231"}