Home NDC 83980-029 etodolac
Product NDC 83980-029
11-digit product format 839800029
Labeler code 83980
Product ID 83980-029_4064e892-4c7a-46a7-9114-3e2bf466e597
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etodolac
Dosage form TABLET
Route ORAL
Labeler Ipca Laboratories Limited
Application ANDA204729
Marketing category ANDA
Marketing start 2026-02-13
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 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 A204729-001 ETODOLAC ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 A204729-002 ETODOLAC ETODOLAC 500MG TABLET / ORAL AB 2024-05-01
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 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204729-001 ETODOLAC 400MG TABLET / ORAL AB 2024-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204729-002 ETODOLAC 500MG TABLET / ORAL AB 2024-05-01 a50c72e98297…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83980-029-01 etodolac 100 in 1 BOTTLE TABLET 100 1 83980-029-10 etodolac 1000 in 1 BOTTLE TABLET 1000 1 83980-029-13 etodolac 30 in 1 BOTTLE TABLET 30 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83980-029-01 83980002901 100 TABLET in 1 BOTTLE (83980-029-01) 100 tablet 2026-02-13 No No Current 83980-029-10 83980002910 1000 TABLET in 1 BOTTLE (83980-029-10) 1000 tablet 2026-02-13 No No Current 83980-029-13 83980002913 30 TABLET in 1 BOTTLE (83980-029-13) 30 tablet 2026-02-13 No No Current