NDC 60505-0102-01 - 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
60505-0102
Requested NDC
60505-0102-01
Package NDCs from labels
60505-0102-1, 60505-0102-2, 60505-0102-01
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyApotex Corp. | Apotex Inc.2026-09-11HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyREMEDYREPACK INC.2026-06-09HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 500 mg Rx onlyPD-Rx Pharmaceuticals, Inc.2026-05-05HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Bryant Ranch PrepackBryant Ranch Prepack2024-09-05HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyMedsource Pharmaceuticals | Apotex Inc.2024-03-05HUMAN PRESCRIPTION DRUG LABEL
Etodolac - A-S Medication SolutionsA-S Medication Solutions2023-12-10HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Proficient Rx LPProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Quality Care Products, LLCQuality Care Products, LLC2022-08-01HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC - DIRECT RXDIRECT RX2020-01-20HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx onlyPreferred Pharmaceuticals Inc.2019-09-16HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC - DIRECT RXDIRECT RX2019-04-30HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Aidarex Pharmaceuticals LLC | Aidarex PharmaceuticalsAidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals2018-08-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0102-1Etodolac100 in 1 BOTTLETABLET, FILM COATED10016
60505-0102-2Etodolac500 in 1 BOTTLETABLET, FILM COATED50016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0102ETODOLAC TABLET, FILM COATED [APOTEX CORP.]15Current NDC, Legacy NDC, 2 package rows20240809_4d682f98-1e8a-4c2b-6df3-169d2ed10dc1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0102-1EA - Each60505-01024b45057f-ad61-4cd5-9d3c-dbc1ec0f2c1012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [APOTEX CORP.]5
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC TABLET, FILM COATED [DIRECT RX]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UETODOLAC TABLET, FILM COATED [DIRECT RX]1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTETODOLAC TABLET, FILM COATED [DIRECT RX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOETODOLAC TABLET, FILM COATED [DIRECT RX]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC TABLET, FILM COATED [DIRECT RX]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC TABLET, FILM COATED [DIRECT RX]1
PovidoneINACTIVE INGREDIENTFZ989GH94EETODOLAC TABLET, FILM COATED [DIRECT RX]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2ETODOLAC TABLET, FILM COATED [DIRECT RX]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETODOLAC TABLET, FILM COATED [DIRECT RX]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 11 of 112 · 2,235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f968058-e851-86d0-e063-6294a90aa7862026-04-16WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f970778-97d6-40a9-e063-6394a90a6c892026-04-16WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f81e482-8111-451c-e063-6294a90ad1482026-04-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
unii: 15FIX9V2JP
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
unii: 15FIX9V2JP
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f87e24f-e4ff-03a7-e063-6294a90a23b12026-04-15WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
unii: 15FIX9V2JP
EtodolacETODOLACPreferred Pharmaceuticals Inc.117b3005-a8ec-4f76-824c-95ec42dc87a12026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075074
rxcui: 197686
unii: 2M36281008
EtodolacETODOLACPreferred Pharmaceuticals Inc.55ae2e78-d803-496b-b66d-af11403127852026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197686
unii: 2M36281008
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
unii: 15FIX9V2JP
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
unii: 15FIX9V2JP
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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