Home NDC 51655-166 Etodolac
Product NDC 51655-166
11-digit product format 516550166
Labeler code 51655
Product ID 51655-166_48c3f545-4ae6-d18f-e063-6294a90acb45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form CAPSULE
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA075419
Marketing category ANDA
Marketing start 2014-11-13
Substance ETODOLAC
Active strength 300 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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 51655-166-52 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 51655-166-52 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 51655-166-52 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 51655-166-52 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 51655-166-52 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 51655-166-52 9bebd1f3094a…5416666fcb17…
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.
Additional Listing Data#
Finished product Yes
Brand name base Etodolac
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETODOLAC 300 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197685 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 51655-166-52 Etodolac 30 in 1 BOTTLE, DISPENSING CAPSULE 30 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-166 ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241215_7ec87ffd-057e-420c-b8f2-0a6eed4152be.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51655-166-52 51655016652 30 CAPSULE in 1 BOTTLE, DISPENSING (51655-166-52) 30 capsule 2014-11-13 No No Current