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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

etodolac 600 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0381
Product ID 80425-0381_15d6ab3c-a8ab-953b-e063-6394a90a9849
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091134
Listing Expiration 2026-12-31
Marketing Start 2024-04-10

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 804250381
Hyphenated Format 80425-0381

Supplemental Identifiers

RxCUI
310247
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 ANDA091134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0381-1)
source: ndc

Packages (1)

80425-0381-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0381-1)

Ingredients (1)

etodolac (600 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": "15d6ab3c-a8ab-953b-e063-6394a90a9849", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["310247"], "spl_set_id": ["15d6bc8e-1e25-6676-e063-6294a90a0035"], "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": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0381-1)", "package_ndc": "80425-0381-1", "marketing_start_date": "20240410"}], "brand_name": "Etodolac", "product_id": "80425-0381_15d6ab3c-a8ab-953b-e063-6394a90a9849", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0381", "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": "600 mg/1"}], "application_number": "ANDA091134", "marketing_category": "ANDA", "marketing_start_date": "20240410", "listing_expiration_date": "20261231"}