Home NDC 43353-294-60 Etodolac
Product NDC 43353-294
Requested package NDC 43353-294-60
11-digit product format 433530294
Labeler code 43353
Product ID 43353-294_f7a2760f-2274-412b-8dc6-111f547e7e03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075419
Marketing category ANDA
Marketing start 2017-01-05
Marketing end 0000-00-00
Substance ETODOLAC
Active strength 300 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-294 43353-294-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-294 43353-294-60 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A075419-001 ETODOLAC ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 A075419-002 ETODOLAC ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28
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 3 · 82 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 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075419-001 ETODOLAC 200MG CAPSULE / ORAL AB 2000-07-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075419-002 ETODOLAC 300MG CAPSULE / ORAL AB 2000-07-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-294 ETODOLAC (ETODOLAC) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20171021_d8edfe71-a186-4ee1-9287-d4f69fd79da4.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-294-60 43353029460 90 CAPSULE in 1 BOTTLE (43353-294-60) 90 capsule 2017-04-04 0000-00-00 No No Current