NDC 52959-669 - Sentraflox AM-10

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
52959-669
Package NDCs from labels
52959-669-30
Manufacturer
Physician Therapeutics LLC | Pliva | H.J. Harkins Company, Inc. | Targeted Medical Pharma, Inc.
Effective date
2011-08-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sentraflox AM-10Physician Therapeutics LLC | Pliva | H.J. Harkins Company, Inc. | Targeted Medical Pharma, Inc.2011-08-17HUMAN PRESCRIPTION DRUG LABEL
SentroxatinePhysician Therapeutics LLC | Pliva | H.J. Harkins Company, Inc | Targeted Medical Pharma, Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL
GaboxetinePhysician Therapeutics LLC | Pliva | H.J. Harkins Company, Inc. | Targeted Medical Pharma, Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-669-30Sentroxatine30 in 1 BOTTLECAPSULE3010 mg9
52959-669-30Sentraflox AM-1030 in 1 BOTTLECAPSULE3010 mg9
52959-669-30Gaboxetine30 in 1 BOTTLECAPSULE3010 mg8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-669SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9Unmatched20110818_35fee753-acd7-4da2-bd60-973dc6c0b21f.zip
52959-669SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9Unmatched20110815_83df297b-6467-451e-af4d-2c1f996cd009.zip
52959-669GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8Unmatched20110815_52057058-abdb-44ed-b60d-a718c97fbfda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE MOIETYN91BDP6H0XSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE MOIETYN91BDP6H0XSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FLUOXETINEACTIVE MOIETY01K63SUP8DSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FLUOXETINEACTIVE MOIETY01K63SUP8DSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
AMMONIAINACTIVE INGREDIENT5138Q19F1XSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
AMMONIAINACTIVE INGREDIENT5138Q19F1XSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
GELATININACTIVE INGREDIENT2G86QN327LSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
GELATININACTIVE INGREDIENT2G86QN327LSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
SHELLACINACTIVE INGREDIENT46N107B71OSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
SHELLACINACTIVE INGREDIENT46N107B71OSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CHOLINEACTIVE MOIETYN91BDP6H0XGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
FLUOXETINEACTIVE MOIETY01K63SUP8DGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
GELATININACTIVE INGREDIENT2G86QN327LGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
SHELLACINACTIVE INGREDIENT46N107B71OGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8

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 92 of 114 · 2,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINEBryant Ranch Prepackdced86a0-fc08-465c-897c-f8899e6206d52024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEBryant Ranch Prepack493a5946-e750-4500-afd1-8f3fdc1d420e2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076001
rxcui: 310385
unii: I9W7N6B1KJ
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 6DC9Q167V3
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
unii: 15FIX9V2JP
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.80e52273-9741-6aef-eb24-8a93ead85ba72024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma180a07fd-1f6a-4617-b8e0-f938c65ba2732024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs13bc141b-a30f-2661-e063-6294a90aca2b2024-03-15WarningsExact identifier
unii: 15FIX9V2JP
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
unii: 15FIX9V2JP
BB Blanc 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137a1528-c487-8bf3-e063-6294a90ade842024-03-12WarningsExact identifier
unii: 15FIX9V2JP
BB Sienna 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137bff4a-5156-b12c-e063-6394a90abe632024-03-12WarningsExact identifier
unii: 15FIX9V2JP
BB Brite 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13660aee-3b28-7e3e-e063-6294a90a82cc2024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Bronze 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13679e50-01ef-9a8f-e063-6294a90ac5772024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Noir 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs136a7f66-844c-b16a-e063-6294a90aa9752024-03-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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