Home NDC 52959-471 Etodolac
Product NDC 52959-471
11-digit product format 529590471
Labeler code 52959
Product ID 52959-471_fa86884d-639e-4a55-8038-650350c81462
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA075009
Marketing category ANDA
Marketing start 1998-05-20
Marketing end 0000-00-00
Substance ETODOLAC
Active strength 400 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 2019-12-31
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 4 · 231 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A075009-001 ETODOLAC ETODOLAC 400MG TABLET / ORAL 1997-11-26 A075009-002 ETODOLAC ETODOLAC 500MG TABLET / ORAL 1999-12-28
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 · 84 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 2026-08-18 06:07:40 2026-07 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075009-001 ETODOLAC 400MG TABLET / ORAL AB 1997-11-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075009-002 ETODOLAC 500MG TABLET / ORAL AB 1999-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075009-001 ETODOLAC 400MG TABLET / ORAL 1997-11-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075009-002 ETODOLAC 500MG TABLET / ORAL 1999-12-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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 52959-471-02 Etodolac 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 2 52959-471-12 Etodolac 12 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 12 2 52959-471-14 Etodolac 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 2 52959-471-15 Etodolac 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 2 52959-471-20 Etodolac 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 2 52959-471-25 Etodolac 25 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 25 2 52959-471-28 Etodolac 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 2 52959-471-30 Etodolac 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 52959-471-60 Etodolac 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2 52959-471-90 Etodolac 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETODOLAC ACTIVE INGREDIENT 2M36281008 ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 ETODOLAC ACTIVE MOIETY 2M36281008 ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-471 ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 2 Legacy NDC, 10 package rows 20120831_cb26ac8c-294b-4705-8dd9-8c96afc33b8c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-471-02 52959047102 120 in 1 BOTTLE, PLASTIC Historical 52959-471-12 52959047112 12 in 1 BOTTLE, PLASTIC Historical 52959-471-14 52959047114 14 in 1 BOTTLE, PLASTIC Historical 52959-471-15 52959047115 15 in 1 BOTTLE, PLASTIC Historical 52959-471-20 52959047120 20 in 1 BOTTLE, PLASTIC Historical 52959-471-25 52959047125 25 in 1 BOTTLE, PLASTIC Historical 52959-471-28 52959047128 28 in 1 BOTTLE, PLASTIC Historical 52959-471-30 52959047130 30 in 1 BOTTLE, PLASTIC Historical 52959-471-60 52959047160 60 in 1 BOTTLE, PLASTIC Historical 52959-471-90 52959047190 90 in 1 BOTTLE, PLASTIC Historical