etodolac

Generic: etodolac

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

etodolac 500 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1343
Product ID 69238-1343_f5259276-4fc9-4d24-98ee-fd40a89db0d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208834
Listing Expiration 2026-12-31
Marketing Start 2018-06-11

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 692381343
Hyphenated Format 69238-1343

Supplemental Identifiers

RxCUI
197686 199390
UPC
0369238134216 0369238134315
UNII
2M36281008
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

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 (69238-1343-1)
source: ndc

Packages (1)

69238-1343-1 100 TABLET, FILM COATED in 1 BOTTLE (69238-1343-1)

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": "f5259276-4fc9-4d24-98ee-fd40a89db0d4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0369238134216", "0369238134315"], "unii": ["2M36281008"], "rxcui": ["197686", "199390"], "spl_set_id": ["2f306e69-c109-4e60-aaf3-9016a4e2cc33"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69238-1343-1)", "package_ndc": "69238-1343-1", "marketing_start_date": "20180611"}], "brand_name": "Etodolac", "product_id": "69238-1343_f5259276-4fc9-4d24-98ee-fd40a89db0d4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69238-1343", "generic_name": "Etodolac", "labeler_name": "Amneal Pharmaceuticals NY LLC", "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": "20180611", "listing_expiration_date": "20261231"}