Home NDC 71335-3119 Etodolac
Product NDC 71335-3119
11-digit product format 713353119
Labeler code 71335
Product ID 71335-3119_24b80ca8-c835-44c1-b73a-d9a3d5ecd0fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075078
Marketing category ANDA
Marketing start 1998-04-30
Substance ETODOLAC
Active strength 200 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 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 A075078-001 ETODOLAC ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 A075078-002 ETODOLAC ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30
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 · 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 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075078-001 ETODOLAC 200MG CAPSULE / ORAL AB 1998-04-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075078-002 ETODOLAC 300MG CAPSULE / ORAL AB RS 1998-04-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 200 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 197684 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 71335-3119-1 Etodolac 60 in 1 BOTTLE CAPSULE 60 1 71335-3119-2 Etodolac 90 in 1 BOTTLE CAPSULE 90 1 71335-3119-3 Etodolac 18 in 1 BOTTLE CAPSULE 18 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Etodolac ETODOLAC Sun Pharmaceutical Industries, Inc. ec82b108-6a6f-4d1b-82cb-831d4ed36c80 2026-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075078 application number: ANDA075078 Etodolac ETODOLAC Bryant Ranch Prepack ea12933b-2280-4a11-a0e3-554194c53c4d 2026-03-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075078 application number: ANDA075078 ndc (product): 71335-3119 Etodolac ETODOLAC Golden State Medical Supply, Inc. cf17926c-ed90-4fd0-80af-ccee084075e8 2024-11-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075078 application number: ANDA075078
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-3119-1 71335311901 60 CAPSULE in 1 BOTTLE (71335-3119-1) 60 capsule 2026-03-30 No No Current 71335-3119-2 71335311902 90 CAPSULE in 1 BOTTLE (71335-3119-2) 90 capsule 2026-03-30 No No Current 71335-3119-3 71335311903 18 CAPSULE in 1 BOTTLE (71335-3119-3) 18 capsule 2026-03-30 No No Current