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 86 of 114 · 2,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
unii: 15FIX9V2JP
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact identifier
unii: 15FIX9V2JP
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETOPCO ASSOCIATES LLCf14f43e6-ee57-5495-e053-2a95a90a40112024-10-15WarningsExact identifier
unii: 15FIX9V2JP
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
unii: 15FIX9V2JP
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEH.E.B.c5279caf-3af9-d163-e053-2995a90a943b2024-10-15WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions9a151528-2fe0-4059-b7b7-fcb4e80a51e32024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONcfd735d2-df3a-5ed0-e053-2995a90a9f262024-10-14WarningsExact identifier
unii: 15FIX9V2JP
Target Up and Up SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONf99028fa-a17e-4a84-e053-6294a90a927f2024-10-14WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions42c4c341-8282-4961-8581-8a04301625592024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310385
unii: I9W7N6B1KJ
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
unii: 15FIX9V2JP
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
unii: 15FIX9V2JP
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
unii: 15FIX9V2JP
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINEProficient Rx LPcece294b-c414-4832-a8a2-22fb66aabda92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076001
rxcui: 310385
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEProficient Rx LP5ebf287e-fc95-4a2c-a496-62c7cf6cbf382024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
unii: 15FIX9V2JP
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions2f302db0-1c88-44cf-8258-3c1c60afb5a42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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