Home NDC 59651-461 Etodolac
Product NDC 59651-461
11-digit product format 596510461
Labeler code 59651
Product ID 59651-461_c74c3c56-a5ac-40b4-974b-c4f4b05c5df9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA214872
Marketing category ANDA
Marketing start 2026-07-15
Substance ETODOLAC
Active strength 400 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 59651-461 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 59651-461 59651-461-07 UNFINISHED Active or certified unfinished drug listing 2026-10-05
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214872-001 ETODOLAC ETODOLAC 400MG TABLET / ORAL AB 2026-07-15 A214872-002 ETODOLAC ETODOLAC 500MG TABLET / ORAL AB 2026-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A214872-001 ETODOLAC 400MG TABLET / ORAL AB 2026-07-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214872-002 ETODOLAC 500MG TABLET / ORAL AB 2026-07-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214872-001 ETODOLAC 400MG TABLET / ORAL AB 2026-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214872-002 ETODOLAC 500MG TABLET / ORAL AB 2026-07-15 caaa826d4ba7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Etodolac
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETODOLAC 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2M36281008 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197686 Internal RxNorm lookup 199390 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-461-01 59651046101 100 TABLET, FILM COATED in 1 BOTTLE (59651-461-01) 2026-07-15 No No Current 59651-461-07 59651046107 1600 TABLET, FILM COATED in 1 BAG (59651-461-07) 15-JUL-26 Current