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 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7300
Product ID 68788-7300_eef62abe-3257-4bf2-8b70-10302e7a304e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208834
Listing Expiration 2026-12-31
Marketing Start 2019-01-07

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 687887300
Hyphenated Format 68788-7300

Supplemental Identifiers

RxCUI
199390
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 ANDA208834 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-7300-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-7300-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-7300-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-7300-6)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68788-7300-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-7300-9)
source: ndc

Packages (6)

68788-7300-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-7300-1) 68788-7300-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-7300-2) 68788-7300-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7300-3) 68788-7300-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-7300-6) 68788-7300-8 120 TABLET, FILM COATED in 1 BOTTLE (68788-7300-8) 68788-7300-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-7300-9)

Ingredients (1)

etodolac (500 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": "eef62abe-3257-4bf2-8b70-10302e7a304e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["199390"], "spl_set_id": ["2ade1463-452e-4a62-a632-5f8629176535"], "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 (68788-7300-1)", "package_ndc": "68788-7300-1", "marketing_start_date": "20190107"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-7300-2)", "package_ndc": "68788-7300-2", "marketing_start_date": "20190107"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-7300-3)", "package_ndc": "68788-7300-3", "marketing_start_date": "20190107"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7300-6)", "package_ndc": "68788-7300-6", "marketing_start_date": "20190107"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68788-7300-8)", "package_ndc": "68788-7300-8", "marketing_start_date": "20190107"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-7300-9)", "package_ndc": "68788-7300-9", "marketing_start_date": "20190107"}], "brand_name": "Etodolac", "product_id": "68788-7300_eef62abe-3257-4bf2-8b70-10302e7a304e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-7300", "generic_name": "Etodolac", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "500 mg/1"}], "application_number": "ANDA208834", "marketing_category": "ANDA", "marketing_start_date": "20190107", "listing_expiration_date": "20261231"}