etodolac

Generic: etodolac

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

etodolac 400 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8805
Product ID 63629-8805_bf9bfa1f-7a0d-46b5-8504-8164d7d93a81
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 636298805
Hyphenated Format 63629-8805

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
  • 100 TABLET, FILM COATED in 1 BOTTLE (63629-8805-1)
source: ndc

Packages (1)

63629-8805-1 100 TABLET, FILM COATED in 1 BOTTLE (63629-8805-1)

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": "bf9bfa1f-7a0d-46b5-8504-8164d7d93a81", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["197686"], "spl_set_id": ["479bce92-2066-46ed-b4bb-8c7a59edfffd"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (63629-8805-1)", "package_ndc": "63629-8805-1", "marketing_start_date": "20030501"}], "brand_name": "Etodolac", "product_id": "63629-8805_bf9bfa1f-7a0d-46b5-8504-8164d7d93a81", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63629-8805", "generic_name": "Etodolac", "labeler_name": "Bryant Ranch Prepack", "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"}