{
"NDC": [
{
"NDCCode": "53405-0008-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (53405-0008-1) ",
"NDC11Code": "53405-0008-01",
"ProductNDC": "53405-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.o.l.",
"NonProprietaryName": "Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (palmatum), Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, Dl-methionine, L-alanine, L-cystine, L-glutamic Acid, L-glutamine, L-lysine, L-methionine, L-serine, Para-aminobenzoic Acid, Potassium Gluconate, Thymus (suis), Thyroidinum (suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene, Vaccinium Macrocarpon, Oxytocin,",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20211206",
"EndMarketingDate": "20261223",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "InLight Creation, LLC.",
"SubstanceName": "STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; FRAGARIA VESCA FRUIT; NIACINAMIDE; RHEUM PALMATUM ROOT; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; UBIDECARENONE; CHOLECALCIFEROL; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SQUALENE; CRANBERRY; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; CANDIDA ALBICANS; OXYTOCIN; PUMPKIN SEED; LEMON JUICE; BROMELAINS; HIPPEASTRUM PUNICEUM WHOLE; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER",
"StrengthNumber": "3; 3; 4; 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 12; 16; 17; 18; 6; 9; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Amino Acid [EPC], Amino Acid [EPC], Amino Acids [CS], Amino Acids [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Methylating Activity [MoA], Methylating Agent [EPC], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vitamin B Complex Member [EPC], Vitamin B Complex [CS], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211206",
"EndMarketingDatePackage": "20261223",
"SamplePackage": "N"
},
{
"NDCCode": "53405-0001-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (53405-0001-1)",
"NDC11Code": "53405-0001-01",
"ProductNDC": "53405-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.o.l.",
"NonProprietaryName": "Stollingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin Serotonin, 5-hydroxytryptophan, Betainum Murriatium, Biotin, Cholinum, Coconut Oil, Co Q 10, Dl-methionine, L-alanine",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131010",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Inlight Creation, LLC",
"SubstanceName": "STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; COCONUT OIL; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; THYROID, PORCINE; CHOLECALCIFEROL; CRANBERRY; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; PUMPKIN SEED; LEMON JUICE; BROMELAINS; ILEX AQUIFOLIUM FRUITING TOP; MALUS SYLVESTRIS FLOWER; HORSE CHESTNUT",
"StrengthNumber": "3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 17; 18; 6; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-05-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "53405-0002-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (53405-0002-1)",
"NDC11Code": "53405-0002-01",
"ProductNDC": "53405-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.o.l.",
"NonProprietaryName": "Stillingia Sylvatica, Zincum Gluconicum, Fragaria Vesca, Niacin, Serotonin, 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Co Q 10, Dl-methionine, L-alanine, L-cysteine, L-cystine, L-glutamic Acid",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131021",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "InLight Creations, LLC",
"SubstanceName": "STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; PUMPKIN SEED; LEMON JUICE; BROMELAINS; MALUS SYLVESTRIS FLOWER; ILEX AQUIFOLIUM FRUITING TOP; HORSE CHESTNUT",
"StrengthNumber": "3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 6; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-05-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "53405-0003-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (53405-0003-1) ",
"NDC11Code": "53405-0003-01",
"ProductNDC": "53405-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.o.l.",
"NonProprietaryName": "Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin, Serotonin, 5-hydroxtryptophan, Betainum Muriaticum, Biotin, Cholinum, Co-enzyme Q-10, Dl-methionine, L-alanine, Cysteinum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131023",
"EndMarketingDate": "20180708",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "InLight Creation, LLC",
"SubstanceName": "STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; CRANBERRY; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; PUMPKIN SEED; LEMON JUICE; BROMELAINS; MALUS DOMESTICA FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; HORSE CHESTNUT",
"StrengthNumber": "3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 6; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131023",
"EndMarketingDatePackage": "20180708",
"SamplePackage": "N"
},
{
"NDCCode": "53405-0004-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (53405-0004-1) ",
"NDC11Code": "53405-0004-01",
"ProductNDC": "53405-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.o.l.",
"NonProprietaryName": "Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vescus, Niacin, Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140707",
"EndMarketingDate": "20191224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "InLight Creation, LLC.",
"SubstanceName": "STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; THYROID, PORCINE; CHOLECALCIFEROL; CRANBERRY; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; CANDIDA ALBICANS; PUMPKIN SEED; LEMON JUICE; BROMELAINS; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER",
"StrengthNumber": "3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 12; 17; 18; 6; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140707",
"EndMarketingDatePackage": "20191224",
"SamplePackage": "N"
},
{
"NDCCode": "53405-0005-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (53405-0005-1) ",
"NDC11Code": "53405-0005-01",
"ProductNDC": "53405-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.o.l.",
"NonProprietaryName": "Rosa Canina, Flos, Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (officinale), Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, Dl-methionine, L-alanine, L-cystine, L-glutamic Acid, L-glutamine, L-lysine, L-methionine, L-serine, Oxytocin Acetate, Para-aminobenzoic Acid, Potassium Gluconate, Thymus (suis), Thyroidinum (suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20170817",
"EndMarketingDate": "20200714",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "InLight Creation, LLC.",
"SubstanceName": "ROSA CANINA FLOWER; STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; RHEUM OFFICINALE ROOT; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; OXYTOCIN ACETATE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SQUALENE; CRANBERRY; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; CANDIDA ALBICANS; PUMPKIN SEED; LEMON JUICE; HIPPEASTRUM PUNICEUM WHOLE; BROMELAINS; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER",
"StrengthNumber": "3; 3; 3; 4; 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 3; 6; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170817",
"EndMarketingDatePackage": "20200714",
"SamplePackage": "N"
},
{
"NDCCode": "53405-0007-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (53405-0007-1) ",
"NDC11Code": "53405-0007-01",
"ProductNDC": "53405-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.o.l.",
"NonProprietaryName": "Rosa Canina, Flos, Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (officinale), Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, Dl-methionine, L-alanine, L-cystine, L-glutamic Acid, L-glutamine, L-lysine, L-methionine, L-serine, Oxytocin Acetate, Para-aminobenzoic Acid, Potassium Gluconate, Thymus (suis), Thyroidinum (suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20170822",
"EndMarketingDate": "20240719",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "InLight Creation, LLC.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ALANINE; ALPINE STRAWBERRY; AMINOBENZOIC ACID; BETAINE HYDROCHLORIDE; BIOTIN; BORRELIA BURGDORFERI; BROMELAINS; CANDIDA ALBICANS; CHOLECALCIFEROL; CHOLINE HYDROXIDE; COCONUT OIL; COPPER; CRANBERRY; CYSTEINE; CYSTINE; DOPAMINE HYDROCHLORIDE; GLUTAMIC ACID; GLUTAMINE; HIPPEASTRUM PUNICEUM WHOLE; ILEX AQUIFOLIUM FLOWERING TOP; LEMON JUICE; LITHIUM BROMIDE; LYSINE; MALUS DOMESTICA FLOWER; METHIONINE; NIACINAMIDE; OXITRIPTAN; OXYTOCIN ACETATE; PHENYLALANINE; POTASSIUM GLUCONATE; PUMPKIN SEED; RACEMETHIONINE; RHEUM OFFICINALE ROOT; ROSA CANINA FLOWER; SELENIUM; SELENIUM DIOXIDE; SERINE; SEROTONIN HYDROCHLORIDE; SQUALENE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; SUS SCROFA THYROID; THIAMINE HYDROCHLORIDE; UBIDECARENONE; ZINC GLUCONATE",
"StrengthNumber": "30; 6; 5; 6; 6; 6; 12; 6; 12; 6; 6; 12; 8; 7; 6; 6; 7; 6; 6; 3; 30; 18; 7; 6; 30; 6; 5; 5; 6; 8; 6; 17; 6; 5; 3; 8; 8; 6; 5; 7; 3; 6; 6; 4; 6; 3",
"StrengthUnit": "[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Amino Acid [EPC], Amino Acid [EPC], Amino Acids [CS], Amino Acids [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Methylating Activity [MoA], Methylating Agent [EPC], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vitamin B Complex Member [EPC], Vitamin B Complex [CS], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170822",
"EndMarketingDatePackage": "20240719",
"SamplePackage": "N",
"IndicationAndUsage": "Support of fingernails, hair and skin."
},
{
"NDCCode": "0008-0045-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-01",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0045-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-02",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0100-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0100-01",
"ProductNDC": "0008-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besponsa",
"NonProprietaryName": "Inotuzumab Ozogamicin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761040",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "INOTUZUMAB OZOGAMICIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170818",
"SamplePackage": "N",
"IndicationAndUsage": "BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.",
"Description": "Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0."
},
{
"NDCCode": "0008-0407-03",
"PackageDescription": "1 mL in 1 VIAL (0008-0407-03)",
"NDC11Code": "00008-0407-03",
"ProductNDC": "0008-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Antivenin (micrurus Fulvius)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19670601",
"EndMarketingDate": "20170331",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "0008-0423-03",
"PackageDescription": "1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) ",
"NDC11Code": "00008-0423-03",
"ProductNDC": "0008-0423",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "North American Coral Snake Antivenin (equine)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161012",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "250",
"StrengthUnit": "[arb'U]/10mL",
"Status": "Active",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161012",
"SamplePackage": "N",
"IndicationAndUsage": "North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).",
"Description": "North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol."
},
{
"NDCCode": "0008-0606-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)",
"NDC11Code": "00008-0606-01",
"ProductNDC": "0008-0606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "0008-0607-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)",
"NDC11Code": "00008-0607-01",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "0008-0607-04",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00008-0607-04",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "0008-0833-03",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) ",
"NDC11Code": "00008-0833-03",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0833-20",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) ",
"NDC11Code": "00008-0833-20",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0833-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) ",
"NDC11Code": "00008-0833-21",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0833-22",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) ",
"NDC11Code": "00008-0833-22",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0836-03",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0836-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0836-02) ",
"NDC11Code": "00008-0836-03",
"ProductNDC": "0008-0836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0836-20",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-20) ",
"NDC11Code": "00008-0836-20",
"ProductNDC": "0008-0836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0836-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-21) ",
"NDC11Code": "00008-0836-21",
"ProductNDC": "0008-0836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
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"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
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"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
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"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
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"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-22) ",
"NDC11Code": "00008-0836-22",
"ProductNDC": "0008-0836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ProprietaryNameSuffix": "Xr",
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"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
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"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0837-03",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0837-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0837-02) ",
"NDC11Code": "00008-0837-03",
"ProductNDC": "0008-0837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
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"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0837-20",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-20) ",
"NDC11Code": "00008-0837-20",
"ProductNDC": "0008-0837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
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"RouteName": "ORAL",
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"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0837-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-21) ",
"NDC11Code": "00008-0837-21",
"ProductNDC": "0008-0837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
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"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
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"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
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},
{
"NDCCode": "0008-0837-22",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-22) ",
"NDC11Code": "00008-0837-22",
"ProductNDC": "0008-0837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "CAPSULE, EXTENDED RELEASE",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
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"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0841-17",
"PackageDescription": "5 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0008-0841-17)",
"NDC11Code": "00008-0841-17",
"ProductNDC": "0008-0841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protonix",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-15"
},
{
"NDCCode": "0008-0841-81",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0841-81) ",
"NDC11Code": "00008-0841-81",
"ProductNDC": "0008-0841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protonix",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
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"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20000501",
"SamplePackage": "N",
"IndicationAndUsage": "PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for.",
"Description": "The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. PROTONIX is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength 40 mg pantoprazole, (equivalent to 45.1 mg of pantoprazole sodium), and as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). PROTONIX Delayed-Release Tablets contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2. PROTONIX For Delayed-Release Oral Suspension contains the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide."
},
{
"NDCCode": "0008-0841-99",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0841-99) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00008-0841-99",
"ProductNDC": "0008-0841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protonix",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
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"StartMarketingDate": "20000501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
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}
]
}
{"NDC":[{"NDCCode":"53405-0008-1","ProprietaryName":"E.o.l.","NonProprietaryName":"Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (palmatum), Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, Dl-methionine, L-alanine, L-cystine, L-glutamic Acid, L-glutamine, L-lysine, L-methionine, L-serine, Para-aminobenzoic Acid, Potassium Gluconate, Thymus (suis), Thyroidinum (suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene, Vaccinium Macrocarpon, Oxytocin,"},{"NDCCode":"53405-0001-1","ProprietaryName":"E.o.l.","NonProprietaryName":"Stollingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin Serotonin, 5-hydroxytryptophan, Betainum Murriatium, Biotin, Cholinum, Coconut Oil, Co Q 10, Dl-methionine, L-alanine"},{"NDCCode":"53405-0002-1","ProprietaryName":"E.o.l.","NonProprietaryName":"Stillingia Sylvatica, Zincum Gluconicum, 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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>InLight Creation, LLC.</LabelerName>
<SubstanceName>STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; FRAGARIA VESCA FRUIT; NIACINAMIDE; RHEUM PALMATUM ROOT; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; UBIDECARENONE; CHOLECALCIFEROL; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SQUALENE; CRANBERRY; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; CANDIDA ALBICANS; OXYTOCIN; PUMPKIN SEED; LEMON JUICE; BROMELAINS; HIPPEASTRUM PUNICEUM WHOLE; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER</SubstanceName>
<StrengthNumber>3; 3; 4; 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 12; 16; 17; 18; 6; 9; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Amino Acid [EPC], Amino Acid [EPC], Amino Acids [CS], Amino Acids [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Methylating Activity [MoA], Methylating Agent [EPC], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vitamin B Complex Member [EPC], Vitamin B Complex [CS], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211206</StartMarketingDatePackage>
<EndMarketingDatePackage>20261223</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53405-0001-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (53405-0001-1)</PackageDescription>
<NDC11Code>53405-0001-01</NDC11Code>
<ProductNDC>53405-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.o.l.</ProprietaryName>
<NonProprietaryName>Stollingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin Serotonin, 5-hydroxytryptophan, Betainum Murriatium, Biotin, Cholinum, Coconut Oil, Co Q 10, Dl-methionine, L-alanine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131010</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Inlight Creation, LLC</LabelerName>
<SubstanceName>STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; COCONUT OIL; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; THYROID, PORCINE; CHOLECALCIFEROL; CRANBERRY; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; PUMPKIN SEED; LEMON JUICE; BROMELAINS; ILEX AQUIFOLIUM FRUITING TOP; MALUS SYLVESTRIS FLOWER; HORSE CHESTNUT</SubstanceName>
<StrengthNumber>3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 17; 18; 6; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53405-0002-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (53405-0002-1)</PackageDescription>
<NDC11Code>53405-0002-01</NDC11Code>
<ProductNDC>53405-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.o.l.</ProprietaryName>
<NonProprietaryName>Stillingia Sylvatica, Zincum Gluconicum, Fragaria Vesca, Niacin, Serotonin, 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Co Q 10, Dl-methionine, L-alanine, L-cysteine, L-cystine, L-glutamic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131021</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>InLight Creations, LLC</LabelerName>
<SubstanceName>STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; PUMPKIN SEED; LEMON JUICE; BROMELAINS; MALUS SYLVESTRIS FLOWER; ILEX AQUIFOLIUM FRUITING TOP; HORSE CHESTNUT</SubstanceName>
<StrengthNumber>3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 6; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53405-0003-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (53405-0003-1) </PackageDescription>
<NDC11Code>53405-0003-01</NDC11Code>
<ProductNDC>53405-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.o.l.</ProprietaryName>
<NonProprietaryName>Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin, Serotonin, 5-hydroxtryptophan, Betainum Muriaticum, Biotin, Cholinum, Co-enzyme Q-10, Dl-methionine, L-alanine, Cysteinum,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131023</StartMarketingDate>
<EndMarketingDate>20180708</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>InLight Creation, LLC</LabelerName>
<SubstanceName>STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; CRANBERRY; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; PUMPKIN SEED; LEMON JUICE; BROMELAINS; MALUS DOMESTICA FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; HORSE CHESTNUT</SubstanceName>
<StrengthNumber>3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 6; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131023</StartMarketingDatePackage>
<EndMarketingDatePackage>20180708</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53405-0004-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (53405-0004-1) </PackageDescription>
<NDC11Code>53405-0004-01</NDC11Code>
<ProductNDC>53405-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.o.l.</ProprietaryName>
<NonProprietaryName>Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vescus, Niacin, Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<EndMarketingDate>20191224</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>InLight Creation, LLC.</LabelerName>
<SubstanceName>STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; THYROID, PORCINE; CHOLECALCIFEROL; CRANBERRY; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; CANDIDA ALBICANS; PUMPKIN SEED; LEMON JUICE; BROMELAINS; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER</SubstanceName>
<StrengthNumber>3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 12; 17; 18; 6; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140707</StartMarketingDatePackage>
<EndMarketingDatePackage>20191224</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53405-0005-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (53405-0005-1) </PackageDescription>
<NDC11Code>53405-0005-01</NDC11Code>
<ProductNDC>53405-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.o.l.</ProprietaryName>
<NonProprietaryName>Rosa Canina, Flos, Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (officinale), Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, Dl-methionine, L-alanine, L-cystine, L-glutamic Acid, L-glutamine, L-lysine, L-methionine, L-serine, Oxytocin Acetate, Para-aminobenzoic Acid, Potassium Gluconate, Thymus (suis), Thyroidinum (suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<EndMarketingDate>20200714</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>InLight Creation, LLC.</LabelerName>
<SubstanceName>ROSA CANINA FLOWER; STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; RHEUM OFFICINALE ROOT; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; OXYTOCIN ACETATE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SQUALENE; CRANBERRY; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; CANDIDA ALBICANS; PUMPKIN SEED; LEMON JUICE; HIPPEASTRUM PUNICEUM WHOLE; BROMELAINS; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER</SubstanceName>
<StrengthNumber>3; 3; 3; 4; 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 3; 6; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170817</StartMarketingDatePackage>
<EndMarketingDatePackage>20200714</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53405-0007-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (53405-0007-1) </PackageDescription>
<NDC11Code>53405-0007-01</NDC11Code>
<ProductNDC>53405-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.o.l.</ProprietaryName>
<NonProprietaryName>Rosa Canina, Flos, Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (officinale), Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, Dl-methionine, L-alanine, L-cystine, L-glutamic Acid, L-glutamine, L-lysine, L-methionine, L-serine, Oxytocin Acetate, Para-aminobenzoic Acid, Potassium Gluconate, Thymus (suis), Thyroidinum (suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170822</StartMarketingDate>
<EndMarketingDate>20240719</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>InLight Creation, LLC.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ALANINE; ALPINE STRAWBERRY; AMINOBENZOIC ACID; BETAINE HYDROCHLORIDE; BIOTIN; BORRELIA BURGDORFERI; BROMELAINS; CANDIDA ALBICANS; CHOLECALCIFEROL; CHOLINE HYDROXIDE; COCONUT OIL; COPPER; CRANBERRY; CYSTEINE; CYSTINE; DOPAMINE HYDROCHLORIDE; GLUTAMIC ACID; GLUTAMINE; HIPPEASTRUM PUNICEUM WHOLE; ILEX AQUIFOLIUM FLOWERING TOP; LEMON JUICE; LITHIUM BROMIDE; LYSINE; MALUS DOMESTICA FLOWER; METHIONINE; NIACINAMIDE; OXITRIPTAN; OXYTOCIN ACETATE; PHENYLALANINE; POTASSIUM GLUCONATE; PUMPKIN SEED; RACEMETHIONINE; RHEUM OFFICINALE ROOT; ROSA CANINA FLOWER; SELENIUM; SELENIUM DIOXIDE; SERINE; SEROTONIN HYDROCHLORIDE; SQUALENE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; SUS SCROFA THYROID; THIAMINE HYDROCHLORIDE; UBIDECARENONE; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>30; 6; 5; 6; 6; 6; 12; 6; 12; 6; 6; 12; 8; 7; 6; 6; 7; 6; 6; 3; 30; 18; 7; 6; 30; 6; 5; 5; 6; 8; 6; 17; 6; 5; 3; 8; 8; 6; 5; 7; 3; 6; 6; 4; 6; 3</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Amino Acid [EPC], Amino Acid [EPC], Amino Acids [CS], Amino Acids [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Methylating Activity [MoA], Methylating Agent [EPC], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vitamin B Complex Member [EPC], Vitamin B Complex [CS], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170822</StartMarketingDatePackage>
<EndMarketingDatePackage>20240719</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Support of fingernails, hair and skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0008-0045-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-01</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0045-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-02</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0100-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0100-01</NDC11Code>
<ProductNDC>0008-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besponsa</ProprietaryName>
<NonProprietaryName>Inotuzumab Ozogamicin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761040</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>INOTUZUMAB OZOGAMICIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.</IndicationAndUsage>
<Description>Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0.</Description>
</NDC>
<NDC>
<NDCCode>0008-0407-03</NDCCode>
<PackageDescription>1 mL in 1 VIAL (0008-0407-03)</PackageDescription>
<NDC11Code>00008-0407-03</NDC11Code>
<ProductNDC>0008-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Antivenin (micrurus Fulvius)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19670601</StartMarketingDate>
<EndMarketingDate>20170331</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0423-03</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) </PackageDescription>
<NDC11Code>00008-0423-03</NDC11Code>
<ProductNDC>0008-0423</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>North American Coral Snake Antivenin (equine)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161012</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>[arb'U]/10mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).</IndicationAndUsage>
<Description>North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol.</Description>
</NDC>
<NDC>
<NDCCode>0008-0606-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)</PackageDescription>
<NDC11Code>00008-0606-01</NDC11Code>
<ProductNDC>0008-0606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)</PackageDescription>
<NDC11Code>00008-0607-01</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-04</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-0607-04</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0833-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) </PackageDescription>
<NDC11Code>00008-0833-03</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-20</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) </PackageDescription>
<NDC11Code>00008-0833-20</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) </PackageDescription>
<NDC11Code>00008-0833-21</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0833-22</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) </PackageDescription>
<NDC11Code>00008-0833-22</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0836-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0836-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0836-02) </PackageDescription>
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<ProductNDC>0008-0836</ProductNDC>
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<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0836-20</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-20) </PackageDescription>
<NDC11Code>00008-0836-20</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
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<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0836-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-21) </PackageDescription>
<NDC11Code>00008-0836-21</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
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<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0836-22</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-22) </PackageDescription>
<NDC11Code>00008-0836-22</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0837-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0837-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0837-02) </PackageDescription>
<NDC11Code>00008-0837-03</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0837-20</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-20) </PackageDescription>
<NDC11Code>00008-0837-20</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0837-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-21) </PackageDescription>
<NDC11Code>00008-0837-21</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0837-22</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-22) </PackageDescription>
<NDC11Code>00008-0837-22</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0841-17</NDCCode>
<PackageDescription>5 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0008-0841-17)</PackageDescription>
<NDC11Code>00008-0841-17</NDC11Code>
<ProductNDC>0008-0841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protonix</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0841-81</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0841-81) </PackageDescription>
<NDC11Code>00008-0841-81</NDC11Code>
<ProductNDC>0008-0841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protonix</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. PROTONIX is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength 40 mg pantoprazole, (equivalent to 45.1 mg of pantoprazole sodium), and as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). PROTONIX Delayed-Release Tablets contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2. PROTONIX For Delayed-Release Oral Suspension contains the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0841-99</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0841-99) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-0841-99</NDC11Code>
<ProductNDC>0008-0841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protonix</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-07</LastUpdate>
</NDC>
</NDCList>