Home NDC 67296-0595 ETODOLAC
Product NDC 67296-0595
11-digit product format 672960595
Labeler code 67296
Product ID 67296-0595_1f185c52-0399-4844-8e3e-6b48c6c221b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etodolac
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RedPharm Drug Inc.
Application ANDA074819
Marketing category ANDA
Marketing start 2008-12-01
Marketing end 0000-00-00
Substance ETODOLAC
Active strength 400 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A074819-001 ETODOLAC ETODOLAC 400MG TABLET / ORAL 1997-02-28 A074819-002 ETODOLAC ETODOLAC 500MG TABLET / ORAL 1998-04-28
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.
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 2026-08-01 22:54:32 2026-06 A074819-001 ETODOLAC 400MG TABLET / ORAL 1997-02-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A074819-002 ETODOLAC 500MG TABLET / ORAL 1998-04-28 a50c72e98297…
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 67296-0595-1 ETODOLAC 15 in 1 BOTTLE TABLET, FILM COATED 15 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Etodolac ACTIVE INGREDIENT 2M36281008 ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 Etodolac ACTIVE MOIETY 2M36281008 ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 HYPROMELLOSE 2910 (15000 MPA.S) INACTIVE INGREDIENT 288VBX44JC ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 Povidone INACTIVE INGREDIENT FZ989GH94E ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-0595 ETODOLAC TABLET, FILM COATED [REDPHARM DRUG INC.] 1 Legacy NDC, 1 package rows 20110714_82ef8726-d6c8-458a-86d5-4ec5fd514681.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 67296-0595-1 67296059501 15 in 1 BOTTLE Historical