FDA.reportPublic FDA data

NDC 68382-271-30 - 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
68382-271
Requested NDC
68382-271-30
Package NDCs from labels
68382-271-01, 68382-271-05, 68382-271-10, 68382-271-30, 68382-271-77, 68382-271-14
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2024-12-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Etodolac Extended-Release Tablets, USPNuCare Pharmaceuticals, Inc.2024-12-24HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2024-09-20HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Proficient Rx LPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-271-01Etodolac100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10014
68382-271-05Etodolac500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50014
68382-271-10Etodolac1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100014
68382-271-14Etodolac60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6014
68382-271-30Etodolac1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE114
68382-271-77Etodolac100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-271ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 6 package rows20240921_7ef79e43-0628-4795-937e-ebb752d79133.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-271-01EA - Each68382-271302c2179-f797-48c2-afe8-ff3492d22a8712014-06-03
68382-271-14EA - Each68382-2715cef453b-335b-4c4a-a0d6-f133f341e66812014-06-03

DailyMed Socrata Ingredients#

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

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 9 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 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.556eaa67-d30d-4095-a981-c65f98d3acdd2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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