Home NDC 50090-6739 Etodolac
Product NDC 50090-6739
11-digit product format 500906739
Labeler code 50090
Product ID 50090-6739_523e2e08-af46-4003-8112-80de28f3bd86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
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 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199390 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 50090-6739-5 Etodolac 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6739 ETODOLAC TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 1 Current NDC, 1 package rows 20231018_06f602d1-6faf-41c8-bcfd-33e51f4ca636.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 50090-6739-5 50090673905 60 TABLET, FILM COATED in 1 BOTTLE (50090-6739-5) 2023-10-12 No No Current