etodolac

Generic: etodolac

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

etodolac 600 mg/1

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-4053
Product ID 51672-4053_28681979-a277-8b4c-e063-6394a90a2235
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076174
Listing Expiration 2026-12-31
Marketing Start 2003-03-13

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 516724053
Hyphenated Format 51672-4053

Supplemental Identifiers

RxCUI
310245 310247 359500
UPC
0351672405144 0351672405342
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 ANDA076174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-1)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-2)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-3)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-4)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-6)
  • 10 BLISTER PACK in 1 CARTON (51672-4053-9) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (6)

51672-4053-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-1) 51672-4053-2 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-2) 51672-4053-3 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-3) 51672-4053-4 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-4) 51672-4053-6 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-6) 51672-4053-9 10 BLISTER PACK in 1 CARTON (51672-4053-9) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

etodolac (600 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": "28681979-a277-8b4c-e063-6394a90a2235", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0351672405144", "0351672405342"], "unii": ["2M36281008"], "rxcui": ["310245", "310247", "359500"], "spl_set_id": ["2c5b44b4-78d5-43b2-827d-d2763b6672b3"], "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": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-1)", "package_ndc": "51672-4053-1", "marketing_start_date": "20030313"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-2)", "package_ndc": "51672-4053-2", "marketing_start_date": "20030313"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-3)", "package_ndc": "51672-4053-3", "marketing_start_date": "20030313"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-4)", "package_ndc": "51672-4053-4", "marketing_start_date": "20030313"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-6)", "package_ndc": "51672-4053-6", "marketing_start_date": "20030313"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (51672-4053-9)  / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51672-4053-9", "marketing_start_date": "20030313"}], "brand_name": "Etodolac", "product_id": "51672-4053_28681979-a277-8b4c-e063-6394a90a2235", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "51672-4053", "generic_name": "Etodolac", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "600 mg/1"}], "application_number": "ANDA076174", "marketing_category": "ANDA", "marketing_start_date": "20030313", "listing_expiration_date": "20261231"}