FDA.reportPublic FDA data

NDC 65841-778-30 - Etodolac

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65841-778
Requested NDC
65841-778-30
Package NDCs from labels
65841-778-14, 65841-778-01, 65841-778-05, 65841-778-10, 65841-778-30, 65841-778-77
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Etodolac - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-11-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-778-01Etodolac100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
65841-778-05Etodolac500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5008
65841-778-10Etodolac1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10008
65841-778-14Etodolac60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
65841-778-30Etodolac1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE18
65841-778-77Etodolac100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-778ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 6 package rows20241201_0c5f8631-f013-4bbb-b610-0a8a1311844e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]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 2 of 110 · 2,189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EtodolacETODOLACGolden State Medical Supply, Inc.cf17926c-ed90-4fd0-80af-ccee084075e82026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACGolden State Medical Supply, Inc.c59c5108-a09b-2a03-e053-2995a90abba12026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310245
rxcui: 310247
rxcui: 359500
unii: 2M36281008
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.