etodolac

Generic: etodolac

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

etodolac 400 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-804
Product ID 71610-804_141bf837-5a1f-da26-e063-6294a90a20bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076004
Listing Expiration 2026-12-31
Marketing Start 2003-05-01

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 71610804
Hyphenated Format 71610-804

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
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-804-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-804-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-804-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-804-80)
source: ndc

Packages (4)

71610-804-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-804-30) 71610-804-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-804-53) 71610-804-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-804-60) 71610-804-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-804-80)

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": "141bf837-5a1f-da26-e063-6294a90a20bc", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["197686"], "spl_set_id": ["141be3f6-198d-ce46-e063-6294a90a7993"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-804-30)", "package_ndc": "71610-804-30", "marketing_start_date": "20240315"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-804-53)", "package_ndc": "71610-804-53", "marketing_start_date": "20240315"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-804-60)", "package_ndc": "71610-804-60", "marketing_start_date": "20240315"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-804-80)", "package_ndc": "71610-804-80", "marketing_start_date": "20240315"}], "brand_name": "Etodolac", "product_id": "71610-804_141bf837-5a1f-da26-e063-6294a90a20bc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71610-804", "generic_name": "Etodolac", "labeler_name": "Aphena Pharma Solutions - 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": "20030501", "listing_expiration_date": "20261231"}