etodolac

Generic: etodolac

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

etodolac 400 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-777
Product ID 65841-777_12ad7193-e8e8-49cd-871c-e7a4c47f32c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091134
Listing Expiration 2026-12-31
Marketing Start 2014-02-15

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 65841777
Hyphenated Format 65841-777

Supplemental Identifiers

RxCUI
310245 310247 359500
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 ANDA091134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-05)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-10)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-14)
  • 100 BLISTER PACK in 1 CARTON (65841-777-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65841-777-30)
source: ndc

Packages (5)

65841-777-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-01) 65841-777-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-05) 65841-777-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-10) 65841-777-14 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-14) 65841-777-77 100 BLISTER PACK in 1 CARTON (65841-777-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65841-777-30)

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": "12ad7193-e8e8-49cd-871c-e7a4c47f32c4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["2M36281008"], "rxcui": ["310245", "310247", "359500"], "spl_set_id": ["0c5f8631-f013-4bbb-b610-0a8a1311844e"], "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": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-01)", "package_ndc": "65841-777-01", "marketing_start_date": "20140215"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-05)", "package_ndc": "65841-777-05", "marketing_start_date": "20140215"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-10)", "package_ndc": "65841-777-10", "marketing_start_date": "20140215"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-14)", "package_ndc": "65841-777-14", "marketing_start_date": "20140215"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (65841-777-77)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65841-777-30)", "package_ndc": "65841-777-77", "marketing_start_date": "20140215"}], "brand_name": "Etodolac", "product_id": "65841-777_12ad7193-e8e8-49cd-871c-e7a4c47f32c4", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "65841-777", "generic_name": "Etodolac", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "400 mg/1"}], "application_number": "ANDA091134", "marketing_category": "ANDA", "marketing_start_date": "20140215", "listing_expiration_date": "20261231"}