NDC 68084-101-11 - Fluoxetine

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
68084-101
Requested NDC
68084-101-11
Package NDCs from labels
68084-101-11, 68084-101-01
Manufacturer
American Health Packaging
Effective date
2022-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine - American Health PackagingAmerican Health Packaging2022-06-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-101-01EA - Each68084-10159f8afe0-9f86-4827-bf07-834d978c5c6d12014-01-04
68084-101-11EA - Each68084-101a5edac94-8d05-478e-88e5-338ee4d08e1b12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3

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 72 of 142 · 2,822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD4115b653-63ff-703f-e063-6294a90a652a2025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
FluoxetineFLUOXETINEBryant Ranch Prepackc1c7ec04-dd9e-400f-8f49-e900945fc61c2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: ETJ7Z6XBU4
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
unii: 15FIX9V2JP
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
unii: 15FIX9V2JP
ParathyroparSYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, RHUS TOX, SILICEA, PARATHORMONUMEnergique, Inc.bd13617a-c470-4421-8f47-43a98036f40b2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
unii: 15FIX9V2JP
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
unii: 15FIX9V2JP
Kids Mineral Sunscreen SPF50SUNSCREENHello Bello01cc554b-9241-d891-e063-6394a90a84502025-10-02WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINETeva Pharmaceuticals USA, Inc.369dbfba-9de4-433c-8680-2ec047b8f8d92025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
unii: I9W7N6B1KJ
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
unii: 15FIX9V2JP
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
unii: 15FIX9V2JP
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD3fb16579-7cf1-873a-e063-6294a90a9ac12025-09-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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