Home NDC 76385-119 Etodolac
Product NDC 76385-119
11-digit product format 763850119
Labeler code 76385
Product ID 76385-119_c135c9a7-8a1d-4383-b373-a1dbf711567a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA210704
Marketing category ANDA
Marketing start 2021-08-01
Substance ETODOLAC
Active strength 500 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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76385-119-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76385-119-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76385-119-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76385-119-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76385-119-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76385-119-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76385-119-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A210704-001 ETODOLAC ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 A210704-002 ETODOLAC ETODOLAC 500MG TABLET / ORAL AB 2020-12-16
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.
Product history page 1 of 2 · 70 observed 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 2026-02-19 14:30 UTC 2026-02 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Etodolac
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETODOLAC 500 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76385-119-01 Etodolac 100 in 1 BOTTLE TABLET, FILM COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76385-119 ETODOLAC TABLET, FILM COATED [BAYSHORE PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20230111_18215cb7-c833-4a98-a61d-4bedf518a380.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 76385-119-01 76385011901 100 TABLET, FILM COATED in 1 BOTTLE (76385-119-01) 2021-08-01 0000-00-00 No No Current