FDA.reportPublic FDA data

NDC 0093-1015-19 - NABUMETONE

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
0093-1015
Requested NDC
0093-1015-19
Package NDCs from labels
0093-1015-19
Manufacturer
DIRECT RX
Effective date
2020-01-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NABUMETONE - DIRECT RXDIRECT RX2020-01-21HUMAN PRESCRIPTION DRUG LABEL
NABUMETONE - Direct RxDirect Rx2015-08-19HUMAN PRESCRIPTION DRUG LABEL
Nabumetone - NCS HealthCare of KY, Inc dba Vangard LabsNCS HealthCare of KY, Inc dba Vangard Labs2012-04-18HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1015-01EA - Each0093-1015a941b801-68bb-4a27-aa5d-1b9fce94c71812012-07-24
0093-1015-10EA - Each0093-1015b761a9cd-1ee9-4f27-8505-9c7b628f916e12012-07-24
0093-1015-19EA - Each0093-1015d644cd80-c80e-4b0f-9119-f9d580cae80d12012-07-24
0093-1015-93EA - Each0093-10158d6439f4-2715-420f-b8b1-6679962513f212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
NABUMETONEACTIVE INGREDIENTLW0TIW155ZNABUMETONE TABLET, FILM COATED [DIRECT RX]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
NABUMETONEACTIVE MOIETYLW0TIW155ZNABUMETONE TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNABUMETONE TABLET, FILM COATED [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NABUMETONE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82NABUMETONE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4NABUMETONE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNABUMETONE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WENABUMETONE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NABUMETONE TABLET, FILM COATED [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNABUMETONE TABLET, FILM COATED [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NABUMETONE TABLET, FILM COATED [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNABUMETONE TABLET, FILM COATED [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNABUMETONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]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 23 of 143 · 2,846 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcc0f19fc-7b6f-4454-9a77-dc11f0fd12512026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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