etodolac

Generic: etodolac

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

etodolac 500 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 76385-119
Product ID 76385-119_c135c9a7-8a1d-4383-b373-a1dbf711567a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210704
Listing Expiration 2026-12-31
Marketing Start 2021-08-01

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 76385119
Hyphenated Format 76385-119

Supplemental Identifiers

RxCUI
197686 199390
UPC
0376385118013 0376385119010
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 ANDA210704 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76385-119-01)
source: ndc

Packages (1)

76385-119-01 100 TABLET, FILM COATED in 1 BOTTLE (76385-119-01)

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": "c135c9a7-8a1d-4383-b373-a1dbf711567a", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0376385118013", "0376385119010"], "unii": ["2M36281008"], "rxcui": ["197686", "199390"], "spl_set_id": ["18215cb7-c833-4a98-a61d-4bedf518a380"], "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": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76385-119-01)", "package_ndc": "76385-119-01", "marketing_start_date": "20210801"}], "brand_name": "Etodolac", "product_id": "76385-119_c135c9a7-8a1d-4383-b373-a1dbf711567a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76385-119", "generic_name": "Etodolac", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "500 mg/1"}], "application_number": "ANDA210704", "marketing_category": "ANDA", "marketing_start_date": "20210801", "listing_expiration_date": "20261231"}