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 54 of 142 · 2,832 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lip ProtectingTITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544b8f2-2651-4c01-e063-6394a90ae53d2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3531d609-a0d8-cb59-e063-6394a90a4bea2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3532a6a2-dbb5-8111-e063-6294a90aeaeb2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC35338026-525a-d8b3-e063-6394a90a98f52025-12-12Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3541971e-3664-a9f5-e063-6294a90ac2d22025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
unii: 15FIX9V2JP
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
unii: 15FIX9V2JP
Sun Elegant Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDESKIN BY NESRIN3580ae10-1867-cb68-e063-6394a90a72df2025-12-12Exact identifier
unii: 15FIX9V2JP
PROTECTOR SOLAR NON-TINTED SPF SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC358195c0-6d28-1ffe-e063-6394a90a60272025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation3583f860-664b-2658-e063-6394a90a38572025-12-12Exact identifier
unii: 15FIX9V2JP
SPF LipTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359297cd-10e2-6ddd-e063-6394a90a4aa02025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
unii: 15FIX9V2JP
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
unii: 15FIX9V2JP
GERM HPAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.15dc5391-0e6e-45d9-8ac7-142333a907162025-12-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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