etodolac

Generic: etodolac

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

etodolac 200 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0039
Product ID 60505-0039_41e18dea-7642-9715-53b0-db2b46d8265b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075419
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 605050039
Hyphenated Format 60505-0039

Supplemental Identifiers

RxCUI
197684 197685
UPC
0360505004010
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 ANDA075419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (60505-0039-1)
source: ndc

Packages (1)

60505-0039-1 100 CAPSULE in 1 BOTTLE (60505-0039-1)

Ingredients (1)

etodolac (200 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": "41e18dea-7642-9715-53b0-db2b46d8265b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0360505004010"], "unii": ["2M36281008"], "rxcui": ["197684", "197685"], "spl_set_id": ["86c7b7b8-3a98-e5f4-c558-5b5caede6377"], "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": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (60505-0039-1)", "package_ndc": "60505-0039-1", "marketing_start_date": "20030501"}], "brand_name": "Etodolac", "product_id": "60505-0039_41e18dea-7642-9715-53b0-db2b46d8265b", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60505-0039", "generic_name": "Etodolac", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "200 mg/1"}], "application_number": "ANDA075419", "marketing_category": "ANDA", "marketing_start_date": "20030501", "listing_expiration_date": "20261231"}