NDC 68084-692-11 - Duloxetine

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
68084-692
Requested NDC
68084-692-11
Package NDCs from labels
68084-692-11, 68084-692-01
Manufacturer
American Health Packaging
Effective date
2023-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Duloxetine - American Health PackagingAmerican Health Packaging2023-04-28HUMAN PRESCRIPTION DRUG LABEL
Duloxetine - Cardinal Health 107, LLCCardinal Health 107, LLC2022-11-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-692-01EA - Each68084-6924cd41f0e-9b0c-4f75-9d44-c980f72b37ce12014-01-04
68084-692-11EA - Each68084-6921f30a706-d920-4cc3-bb27-f517e0602f6612014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
DULOXETINE HYDROCHLORIDEACTIVE INGREDIENT9044SC542WDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
DULOXETINEACTIVE MOIETYO5TNM5N07UDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
GELATININACTIVE INGREDIENT2G86QN327LDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
SHELLACINACTIVE INGREDIENT46N107B71ODULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDULOXETINE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]4

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 9 of 116 · 2,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDEHave & Be Co., Ltd.4a7e868d-6310-6ee4-e063-6394a90aebce2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
DULOXETINE HYDROCHLORIDEDULOXETINEAlembic Pharmaceuticals Inc.39453971-766d-45bf-a0fd-4658d72bae722026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior53a79ee7-312b-49a2-8a9b-c50794fcd1712026-05-05WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEPort Jervis Laboratories, Inc51169bed-2091-ad2b-e063-6294a90a84b62026-05-05WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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