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 3 of 110 · 2,189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EtodolacETODOLACAurobindo Pharma Limitedc74c3c56-a5ac-40b4-974b-c4f4b05c5df92026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACSun Pharmaceutical Industries, Inc.ec82b108-6a6f-4d1b-82cb-831d4ed36c802026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2M36281008
EtodolacETODOLACTaSun Pharmaceutical Industries, Inc.2c5b44b4-78d5-43b2-827d-d2763b6672b32026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310245
rxcui: 310247
rxcui: 359500
unii: 2M36281008
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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