etodolac

Generic: etodolac

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

etodolac 400 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0190
Product ID 80425-0190_2a99a7c1-c4c5-2b01-e063-6294a90aa3b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076004
Listing Expiration 2026-12-31
Marketing Start 2022-06-14

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 804250190
Hyphenated Format 80425-0190

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 ANDA076004 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0190-2)
source: ndc

Packages (1)

80425-0190-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0190-2)

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": "2a99a7c1-c4c5-2b01-e063-6294a90aa3b8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["197686"], "spl_set_id": ["d83d9f30-c367-f8b3-e053-2a95a90a1f40"], "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": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0190-2)", "package_ndc": "80425-0190-2", "marketing_start_date": "20240217"}], "brand_name": "Etodolac", "product_id": "80425-0190_2a99a7c1-c4c5-2b01-e063-6294a90aa3b8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0190", "generic_name": "Etodolac", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "400 mg/1"}], "application_number": "ANDA076004", "marketing_category": "ANDA", "marketing_start_date": "20220614", "listing_expiration_date": "20261231"}