etodolac

Generic: etodolac

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etodolac
Generic Name etodolac
Labeler northstar rx llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

etodolac 400 mg/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-497
Product ID 16714-497_38568f45-b334-0e6f-e063-6294a90a178a
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 16714497
Hyphenated Format 16714-497

Supplemental Identifiers

RxCUI
310245 310247 359500
UPC
0316714497020 0316714498027
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
  • 400 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02)
source: ndc

Packages (2)

16714-497-01 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01) 16714-497-02 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02)

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": "38568f45-b334-0e6f-e063-6294a90a178a", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0316714497020", "0316714498027"], "unii": ["2M36281008"], "rxcui": ["310245", "310247", "359500"], "spl_set_id": ["107ea9d7-80a9-41a4-b61e-168370127319"], "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": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01)", "package_ndc": "16714-497-01", "marketing_start_date": "20160815"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02)", "package_ndc": "16714-497-02", "marketing_start_date": "20160815"}], "brand_name": "Etodolac", "product_id": "16714-497_38568f45-b334-0e6f-e063-6294a90a178a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "16714-497", "generic_name": "Etodolac", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etodolac", "active_ingredients": [{"name": "ETODOLAC", "strength": "400 mg/1"}], "application_number": "ANDA076174", "marketing_category": "ANDA", "marketing_start_date": "20030313", "listing_expiration_date": "20261231"}