FDA.reportPublic FDA data

NDC 65841-779-30 - 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
65841-779
Requested NDC
65841-779-30
Package NDCs from labels
65841-779-14, 65841-779-01, 65841-779-05, 65841-779-10, 65841-779-30, 65841-779-77
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
65841-779-01Etodolac100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
65841-779-05Etodolac500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5008
65841-779-10Etodolac1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10008
65841-779-14Etodolac60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
65841-779-30Etodolac1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE18
65841-779-77Etodolac100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-779ETODOLAC 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 8 of 110 · 2,189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4d47292f-35f2-4e9f-a9d8-2df57cbe92cf2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior96258152-5255-4f04-9a35-c5a76b9c05202026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5df158da-3280-4ce6-a04c-3709993434002026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbe60feb0-8c16-4ef6-a36f-423ed18e098c2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d7678b4-b082-4911-80a2-c019eb5294142026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior00c9da7c-d4c7-49da-afa9-1fde93a815402026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior201acd8e-23c6-43fd-81dc-a814c3d8160b2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb24806b1-d9da-4373-b072-6d9a262ea3652026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc981ae5e-e7e8-484b-b682-fb96d501e03b2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDEHave & Be Co., Ltd.4a7e868d-6310-6ee4-e063-6394a90aebce2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior53a79ee7-312b-49a2-8a9b-c50794fcd1712026-05-05WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEPort Jervis Laboratories, Inc51169bed-2091-ad2b-e063-6294a90a84b62026-05-05WarningsExact identifier
unii: 15FIX9V2JP
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.41bd86b9-2ef3-49a4-874e-fe8ac68910802026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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