Home NDC 71335-2259 Etodolac
Product NDC 71335-2259
11-digit product format 713352259
Labeler code 71335
Product ID 71335-2259_2b889026-2eb9-4894-a68d-2fcf5a3ceae4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA210704
Marketing category ANDA
Marketing start 2021-08-01
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 2026-12-31
Current FDA listing Yes 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 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 · 72 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 A210704-001 ETODOLAC 400MG TABLET / ORAL AB 2020-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210704-002 ETODOLAC 500MG TABLET / ORAL AB 2020-12-16 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197686 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 71335-2259-1 Etodolac 20 in 1 BOTTLE TABLET, FILM COATED 20 101 71335-2259-2 Etodolac 14 in 1 BOTTLE TABLET, FILM COATED 14 101 71335-2259-3 Etodolac 30 in 1 BOTTLE TABLET, FILM COATED 30 101 71335-2259-4 Etodolac 100 in 1 BOTTLE TABLET, FILM COATED 100 101 71335-2259-5 Etodolac 60 in 1 BOTTLE TABLET, FILM COATED 60 101 71335-2259-6 Etodolac 90 in 1 BOTTLE TABLET, FILM COATED 90 101 71335-2259-7 Etodolac 56 in 1 BOTTLE TABLET, FILM COATED 56 101 71335-2259-8 Etodolac 120 in 1 BOTTLE TABLET, FILM COATED 120 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2259 ETODOLAC TABLET, FILM COATED [BRYANT RANCH PREPACK] 100 Current NDC, 8 package rows 20231031_5e94a98f-d36e-4f28-b79c-6ad8a6793381.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 Sample Exclude flag Status 71335-2259-1 71335225901 20 TABLET, FILM COATED in 1 BOTTLE (71335-2259-1) 2023-10-30 No No Current 71335-2259-2 71335225902 14 TABLET, FILM COATED in 1 BOTTLE (71335-2259-2) 2023-10-30 No No Current 71335-2259-3 71335225903 30 TABLET, FILM COATED in 1 BOTTLE (71335-2259-3) 2023-10-30 No No Current 71335-2259-4 71335225904 100 TABLET, FILM COATED in 1 BOTTLE (71335-2259-4) 2023-10-30 No No Current 71335-2259-5 71335225905 60 TABLET, FILM COATED in 1 BOTTLE (71335-2259-5) 2023-10-30 No No Current 71335-2259-6 71335225906 90 TABLET, FILM COATED in 1 BOTTLE (71335-2259-6) 2023-10-30 No No Current 71335-2259-7 71335225907 56 TABLET, FILM COATED in 1 BOTTLE (71335-2259-7) 2023-10-30 No No Current 71335-2259-8 71335225908 120 TABLET, FILM COATED in 1 BOTTLE (71335-2259-8) 2023-10-30 No No Current