etodolac

Generic: etodolac

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

etodolac 400 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-856
Product ID 43063-856_43f468d8-6312-389d-e063-6294a90abfae
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 43063856
Hyphenated Format 43063-856

Supplemental Identifiers

RxCUI
197686
UPC
0343063856307
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
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-60)
source: ndc

Packages (3)

43063-856-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-20) 43063-856-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-30) 43063-856-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-60)

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": "43f468d8-6312-389d-e063-6294a90abfae", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0343063856307"], "unii": ["2M36281008"], "rxcui": ["197686"], "spl_set_id": ["007c55fa-ef8b-4a8e-bfe5-e47c6e5da727"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-20)", "package_ndc": "43063-856-20", "marketing_start_date": "20180531"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-30)", "package_ndc": "43063-856-30", "marketing_start_date": "20180627"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-60)", "package_ndc": "43063-856-60", "marketing_start_date": "20181101"}], "brand_name": "Etodolac", "product_id": "43063-856_43f468d8-6312-389d-e063-6294a90abfae", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-856", "generic_name": "Etodolac", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}