Home NDC 43353-918 Etodolac
Product NDC 43353-918
11-digit product format 433530918
Labeler code 43353
Product ID 43353-918_fbe19c2c-9e78-41d9-9455-21ed571956e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etodolac
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075078
Marketing category ANDA
Marketing start 1998-04-05
Marketing end 0000-00-00
Substance ETODOLAC
Active strength 200 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 2020-12-31
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 2 · 90 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 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 43353-918-53 Etodolac Capsules, Tablets and ER Tablets, USP 43353-918-60 Etodolac Capsules, Tablets and ER Tablets, USP 43353-918-70 Etodolac Capsules, Tablets and ER Tablets, USP 43353-918-80 Etodolac Capsules, Tablets and ER Tablets, USP 43353-918-87 Etodolac Capsules, Tablets and ER Tablets, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-918-53 Etodolac 60 in 1 BOTTLE, PLASTIC CAPSULE 60 3 43353-918-60 Etodolac 90 in 1 BOTTLE, PLASTIC CAPSULE 90 3 43353-918-70 Etodolac 120 in 1 BOTTLE, PLASTIC CAPSULE 120 3 43353-918-80 Etodolac 180 in 1 BOTTLE, PLASTIC CAPSULE 180 3 43353-918-87 Etodolac 2400 in 1 BOTTLE, PLASTIC CAPSULE 2400 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Etodolac ACTIVE INGREDIENT 2M36281008 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Etodolac ACTIVE MOIETY 2M36281008 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Gelatin INACTIVE INGREDIENT 2G86QN327L ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Isopropyl Alcohol INACTIVE INGREDIENT ND2M416302 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Povidone INACTIVE INGREDIENT FZ989GH94E ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM STARCH GLYCOLATE TYPE B POTATO INACTIVE INGREDIENT 27NA468985 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Water INACTIVE INGREDIENT 059QF0KO0R ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-918 ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC, 5 package rows 20191228_c9f3dc18-d81c-4b02-8ff4-240c247bcbdd.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.
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 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 Marketing end Sample Exclude flag Status 43353-918-53 43353091853 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-53) 60 capsule 2015-02-25 0000-00-00 No No Current 43353-918-60 43353091860 90 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-60) 90 capsule 2015-02-25 0000-00-00 No No Current 43353-918-70 43353091870 120 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-70) 120 capsule 2015-02-25 0000-00-00 No No Current 43353-918-80 43353091880 180 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-80) 180 capsule 2015-02-25 0000-00-00 No No Current 43353-918-87 43353091887 2400 CAPSULE in 1 BOTTLE, PLASTIC (43353-918-87) 2400 capsule 2014-04-02 0000-00-00 No No Current