etodolac

Generic: etodolac

Labeler: ipca laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler ipca laboratories limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

etodolac 200 mg/1

Manufacturer
Ipca Laboratories Limited

Identifiers & Regulatory

Product NDC 83980-031
Product ID 83980-031_fa34700b-9acd-4ccf-9e98-0f88e4a35e12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205448
Listing Expiration 2027-12-31
Marketing Start 2026-02-06

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 83980031
Hyphenated Format 83980-031

Supplemental Identifiers

RxCUI
197684 197685
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 ANDA205448 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (83980-031-01)
  • 500 CAPSULE in 1 BOTTLE (83980-031-05)
  • 30 CAPSULE in 1 BOTTLE (83980-031-13)
source: ndc

Packages (3)

83980-031-01 100 CAPSULE in 1 BOTTLE (83980-031-01) 83980-031-05 500 CAPSULE in 1 BOTTLE (83980-031-05) 83980-031-13 30 CAPSULE in 1 BOTTLE (83980-031-13)

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": "fa34700b-9acd-4ccf-9e98-0f88e4a35e12", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["197684", "197685"], "spl_set_id": ["d583988c-3e7e-4415-b2fd-34049791cd1c"], "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": ["Ipca Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (83980-031-01)", "package_ndc": "83980-031-01", "marketing_start_date": "20260206"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (83980-031-05)", "package_ndc": "83980-031-05", "marketing_start_date": "20260206"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (83980-031-13)", "package_ndc": "83980-031-13", "marketing_start_date": "20260206"}], "brand_name": "etodolac", "product_id": "83980-031_fa34700b-9acd-4ccf-9e98-0f88e4a35e12", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83980-031", "generic_name": "etodolac", "labeler_name": "Ipca Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "200 mg/1"}], "application_number": "ANDA205448", "marketing_category": "ANDA", "marketing_start_date": "20260206", "listing_expiration_date": "20271231"}