{
"NDC": [
{
"NDCCode": "55926-0024-2",
"PackageDescription": "59 mL in 1 PACKAGE (55926-0024-2) ",
"NDC11Code": "55926-0024-02",
"ProductNDC": "55926-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Emuaid",
"NonProprietaryName": "Silver",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140116",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "SILVER",
"StrengthNumber": "10",
"StrengthUnit": "[hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140117",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of these symptoms due to minor wounds and burns, bruises, ulcerations, sunburn, razor burn, scrapes, rashes, blisters, bug bites, and skin eruptions from acne, eczema, or minor infection: burning stinging itching redness stiffness minor pain minor inflammation."
},
{
"NDCCode": "55926-0011-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0011-2)",
"NDC11Code": "55926-0011-02",
"ProductNDC": "55926-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tranquil Remedy No. 11",
"NonProprietaryName": "Adrenalinum, Alfalfa, Ambrosia Artemisiaefolia, Anacardium Orientale, Argentum Nitricum, Avena Sativa, Aesculus Hippocastanum, Flos, Calcarea Carbonica, Carboneum Oxygenisatum, Carpinus Betulus, Flos, Citricum Acidum, Gelsemium Sempervirens, Hypothalamus, Kali Phosphoricum, Lecithin, Natrum Muriaticum, Olea Europaea, Flos, Phosphoricum Acidum, Pituitarum Posterium, Selenium Metallicum, Sepia, Silicea, Thyroidinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "EPINEPHRINE; ALFALFA; AMBROSIA ARTEMISIIFOLIA; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBON MONOXIDE; CARPINUS BETULUS FLOWERING TOP; ANHYDROUS CITRIC ACID; GELSEMIUM SEMPERVIRENS ROOT; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; EGG PHOSPHOLIPIDS; SODIUM CHLORIDE; OLEA EUROPAEA FLOWER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THYROID, UNSPECIFIED",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: 1 mental or physical burnout, 2 nervousness, 3 nervous exhaustion, 4 fatigue, 5 lack of focus, 6 weak memory, 7 irritability, 8 confusion, 9 indifference, 10 ADD/ADHD."
},
{
"NDCCode": "55926-0012-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0012-2)",
"NDC11Code": "55926-0012-02",
"ProductNDC": "55926-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Serenity Remedy No. 12",
"NonProprietaryName": "Aconitum Napellus, Apis Mellifica, Arnica Montana, Arsenicum Album, Belladonna, Bellis Perennis, Bryonia, Calendula Officinalis, Chamomilla, Clematis Erecta, Clematis Vitalba, Flos, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum Perforatum, Ignatia Amara, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Passiflora Incarnata, Phosphorus, Prunus Cerasifera, Flos, Rhus Toxicodendron, Sulphur, Symphytum Officinale, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: 1 mental, physical or emotional stress, 2 tension , 3 apathy, 4 oversensitivity, 5 body pains, 6 nervousness, 7 irritability, 8 fearfulness, 9 sleepessness."
},
{
"NDCCode": "55926-0014-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0014-2)",
"NDC11Code": "55926-0014-02",
"ProductNDC": "55926-0014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Steady Remedy No. 14",
"NonProprietaryName": "Aconitum Napellus, Alfalfa, Argentum Nitricum, Arsenicum Album, Aurum Metallicum, Avena Sativa, Baryta Carbonica, Calcarea Phosphorica, Chamomilla, Gelsemium Sempervirens, Glonoinum, Humulus Lupulus, Ignatia Amara, Kali Arsenicosum, Kali Phosphoricum, Muriaticum Acidum, Natrum Phosphoricum, Passiflora Incarnata, Phosphorus, Staphysagria, Stramonium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "ACONITUM NAPELLUS; ALFALFA; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HOPS; STRYCHNOS IGNATII SEED; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; HYDROCHLORIC ACID; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: 1 anxiety, 2 minor mood swings, 3 restlessness, 4 nervous stomach, 5 nervousness, 6 irritability, 7 stage fright, 8 oversensitivity to various stimuli, 9 intended to complement, not replace, standard medical care."
},
{
"NDCCode": "55926-0015-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0015-2)",
"NDC11Code": "55926-0015-02",
"ProductNDC": "55926-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Slim Remedy No. 15",
"NonProprietaryName": "Adrenalinum, Adrenocorticotrophin, Agrimonia Eupatoria, Flos, Anacardium Orientale, Antimonium Crudum, Calcarea Carbonica, Castanea Sativa, Flos, Cortisone Aceticum, Fucus Vesiculosus, Hypothalamus, Kali Bichromicum, Oleander, Pituitarum Posterium, Sabadilla, Staphysagria, Thyroidinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CASTANEA SATIVA FLOWER; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms contributing to: 1 excessive appetite, 2 overeating, 3 excess weight, 4 consitutional tendency to gain fat, 5 cravings for sweets and starches, 6 water retention, 7 ravenous hunger, 8 abdominal fat."
},
{
"NDCCode": "55926-0016-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0016-2)",
"NDC11Code": "55926-0016-02",
"ProductNDC": "55926-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Regular Remedies No. 16",
"NonProprietaryName": "Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: 1 Occasional constipation and irregularity, 2 Infrequent urges and peristaltic action."
},
{
"NDCCode": "55926-0017-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0017-2)",
"NDC11Code": "55926-0017-02",
"ProductNDC": "55926-0017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Control Remedy No. 17",
"NonProprietaryName": "Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Crotontiglium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: : 1 Diarrhea including loose stool, 2 Bloating and general discomforts, 3 Mucus-like stools, 4 Diarrhea from certain foods, 5 Diarrhea from emotional excitement , 6 Cramps , 7 Gas."
},
{
"NDCCode": "55926-0018-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0018-2)",
"NDC11Code": "55926-0018-02",
"ProductNDC": "55926-0018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Recharge Remedy No. 18",
"NonProprietaryName": "Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: 1 fatigue, 2 drowsiness, 3 inabilty to fall asleep, 4 sweet food cravings, 5 sudden drain of energy, 6 headaches, 7 nausea."
},
{
"NDCCode": "55926-0019-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0019-2)",
"NDC11Code": "55926-0019-02",
"ProductNDC": "55926-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Morale Remedy No. 19",
"NonProprietaryName": "Anacardium Orientale, Aurum Metallicum, Calcarea Carbonica, Cimicifuga Racemosa, Hypericum Perforatum, Ignatia Amara, Kale Bromatum, Natrum Carbonicum, Natrum Sulphuricum, Phosphoricum Acidum, Phosphorus, Pulsatilla, Sepia, Tabacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "SEMECARPUS ANACARDIUM JUICE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; SODIUM CARBONATE; SODIUM SULFATE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOBACCO LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: 1 mood swings, 2 despondency, 3 sadness, 4 introspection, 5 melancholy, 6 despair, 7 Hypersensitivity."
},
{
"NDCCode": "55926-0020-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0020-2)",
"NDC11Code": "55926-0020-02",
"ProductNDC": "55926-0020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothe Remedy No. 20",
"NonProprietaryName": "Belladonna, Bryonia, Capsicum Annuum, Chininum Arsenicosum, Coffea Cruda, Gelsemium Sempervirens, Glonoinum, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Spigelia Anthelmia, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; QUININE ARSENITE; ARABICA COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of: 1 headache pain (throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occiptal, etc), 2 band feeling around the head, 3 morning headache, 4 sun headache."
},
{
"NDCCode": "55926-0021-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0021-2)",
"NDC11Code": "55926-0021-02",
"ProductNDC": "55926-0021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Relieve Remedy No. 21",
"NonProprietaryName": "Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cyclamen Europaeum, Helonias Dioica, Ignatia Amara, Lac Caninum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Platinum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "APIS MELLIFERA; MATRICARIA RECUTITA; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: Temporarily relieves symptoms of PMS: 1 mood swings, 2 irritability, 3 water retention, 4 bloating, 5 cramping, 6 sensitive breasts, 7 sensitivity, 8 weariness, 9 weight gain, 10 swelling, 11 headaches."
},
{
"NDCCode": "55926-0022-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0022-2)",
"NDC11Code": "55926-0022-02",
"ProductNDC": "55926-0022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Invigorate Male Remedy No. 22",
"NonProprietaryName": "Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picricum Acidum, Selenium Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: For temporary relief of: : 1 loss of sexual desire, 2 premature ejaculation, 3 infrequent erection, 4 sexual burnout, 5 low sex drive, 6 poor circulation, 7 lack of stamina."
},
{
"NDCCode": "55926-0023-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (55926-0023-2)",
"NDC11Code": "55926-0023-02",
"ProductNDC": "55926-0023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Invigorate Female Remedy No. 23",
"NonProprietaryName": "Agnus Castus, Aletris Farinosa, Berberis Vulgaris, Caulopyllum Thalictroides, Ferrum Metallicum, Graphites, Helonias Dioica, Ignatia Amara, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriaticum, Onosmodium Virginianum, Pulsatilla, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "CHASTE TREE; ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; IRON; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses: For temporary relief of symptoms of low female sexual energy: 1 Decrease in sexual desire, 2 Decrease on responsiveness and enjoyment, 3 Feeling of fatigue."
},
{
"NDCCode": "55926-0025-2",
"PackageDescription": "59 mL in 1 BOTTLE (55926-0025-2) ",
"NDC11Code": "55926-0025-02",
"ProductNDC": "55926-0025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Emuaidmax",
"NonProprietaryName": "Silver",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140122",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "SILVER",
"StrengthNumber": "10",
"StrengthUnit": "[hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140122",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of these symptoms due to minor wounds and burns, bruises, ulcerations, sunburn, razor burn, scrapes, rashes, blisters, bug bites, and skin eruptions from acne, eczema, or minor infection: burning stinging itching redness stiffness minor pain minor inflammation."
},
{
"NDCCode": "55926-0027-2",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (55926-0027-2) ",
"NDC11Code": "55926-0027-02",
"ProductNDC": "55926-0027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Emuaidmax Concentrate",
"NonProprietaryName": "Silver",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Speer Laboratories, LLC",
"SubstanceName": "SILVER",
"StrengthNumber": "10",
"StrengthUnit": "[hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of these symptoms due to minor wounds and burns, bruises, ulcerations, sunburn, razor burn, scrapes, rashes, blisters, bug bites, and skin eruptions from acne, eczema, or minor infection: burning stinging itching redness stiffness minor pain minor inflammation."
},
{
"NDCCode": "0024-5747-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0024-5747-02) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5747-02",
"ProductNDC": "0024-5747",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlyxin",
"NonProprietaryName": "Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20160727",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208471",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "LIXISENATIDE",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160727",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5831-02",
"PackageDescription": "2 INJECTION in 1 CARTON (0024-5831-02)",
"NDC11Code": "00024-5831-02",
"ProductNDC": "0024-5831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20121115",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "0024-5833-02",
"PackageDescription": "2 INJECTION in 1 CARTON (0024-5833-02)",
"NDC11Code": "00024-5833-02",
"ProductNDC": "0024-5833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20121115",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "0024-5862-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00024-5862-01",
"ProductNDC": "0024-5862",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mozobil",
"NonProprietaryName": "Plerixafor",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022311",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "PLERIXAFOR",
"StrengthNumber": "24",
"StrengthUnit": "mg/1.2mL",
"Pharm_Classes": "Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130901",
"SamplePackage": "N",
"IndicationAndUsage": "Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).",
"Description": "Mozobil (plerixafor) injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C28H54N8. The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula. Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1."
},
{
"NDCCode": "0024-5871-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) ",
"NDC11Code": "00024-5871-02",
"ProductNDC": "0024-5871",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo Max",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.",
"Description": "Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4."
},
{
"NDCCode": "0024-5901-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5901-02) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5901-02",
"ProductNDC": "0024-5901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
},
{
"NDCCode": "0024-5902-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5902-02) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5902-02",
"ProductNDC": "0024-5902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
},
{
"NDCCode": "0024-5903-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0024-5903-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5903-02",
"ProductNDC": "0024-5903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5904-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0024-5904-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5904-02",
"ProductNDC": "0024-5904",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5908-01",
"PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5908-01) / 1.14 mL in 1 SYRINGE (0024-5908-00) ",
"NDC11Code": "00024-5908-01",
"ProductNDC": "0024-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kevzara",
"NonProprietaryName": "Sarilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761037",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "SARILUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170522",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
"Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
},
{
"NDCCode": "0024-5908-02",
"PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5908-02) / 1.14 mL in 1 SYRINGE",
"NDC11Code": "00024-5908-02",
"ProductNDC": "0024-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kevzara",
"NonProprietaryName": "Sarilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761037",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "SARILUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170522",
"SamplePackage": "N",
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},
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"IndicationAndUsage": "DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).",
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"IndicationAndUsage": "DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).",
"Description": "Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9."
}
]
}
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</NDC>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Serenity Remedy No. 12</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Apis Mellifica, Arnica Montana, Arsenicum Album, Belladonna, Bellis Perennis, Bryonia, Calendula Officinalis, Chamomilla, Clematis Erecta, Clematis Vitalba, Flos, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum Perforatum, Ignatia Amara, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Passiflora Incarnata, Phosphorus, Prunus Cerasifera, Flos, Rhus Toxicodendron, Sulphur, Symphytum Officinale, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of: 1 mental, physical or emotional stress, 2 tension , 3 apathy, 4 oversensitivity, 5 body pains, 6 nervousness, 7 irritability, 8 fearfulness, 9 sleepessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0014-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0014-2)</PackageDescription>
<NDC11Code>55926-0014-02</NDC11Code>
<ProductNDC>55926-0014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Steady Remedy No. 14</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Alfalfa, Argentum Nitricum, Arsenicum Album, Aurum Metallicum, Avena Sativa, Baryta Carbonica, Calcarea Phosphorica, Chamomilla, Gelsemium Sempervirens, Glonoinum, Humulus Lupulus, Ignatia Amara, Kali Arsenicosum, Kali Phosphoricum, Muriaticum Acidum, Natrum Phosphoricum, Passiflora Incarnata, Phosphorus, Staphysagria, Stramonium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ALFALFA; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HOPS; STRYCHNOS IGNATII SEED; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; HYDROCHLORIC ACID; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of: 1 anxiety, 2 minor mood swings, 3 restlessness, 4 nervous stomach, 5 nervousness, 6 irritability, 7 stage fright, 8 oversensitivity to various stimuli, 9 intended to complement, not replace, standard medical care.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0015-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0015-2)</PackageDescription>
<NDC11Code>55926-0015-02</NDC11Code>
<ProductNDC>55926-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Slim Remedy No. 15</ProprietaryName>
<NonProprietaryName>Adrenalinum, Adrenocorticotrophin, Agrimonia Eupatoria, Flos, Anacardium Orientale, Antimonium Crudum, Calcarea Carbonica, Castanea Sativa, Flos, Cortisone Aceticum, Fucus Vesiculosus, Hypothalamus, Kali Bichromicum, Oleander, Pituitarum Posterium, Sabadilla, Staphysagria, Thyroidinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CASTANEA SATIVA FLOWER; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms contributing to: 1 excessive appetite, 2 overeating, 3 excess weight, 4 consitutional tendency to gain fat, 5 cravings for sweets and starches, 6 water retention, 7 ravenous hunger, 8 abdominal fat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0016-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0016-2)</PackageDescription>
<NDC11Code>55926-0016-02</NDC11Code>
<ProductNDC>55926-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Regular Remedies No. 16</ProprietaryName>
<NonProprietaryName>Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of: 1 Occasional constipation and irregularity, 2 Infrequent urges and peristaltic action.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0017-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0017-2)</PackageDescription>
<NDC11Code>55926-0017-02</NDC11Code>
<ProductNDC>55926-0017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Control Remedy No. 17</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Crotontiglium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of: : 1 Diarrhea including loose stool, 2 Bloating and general discomforts, 3 Mucus-like stools, 4 Diarrhea from certain foods, 5 Diarrhea from emotional excitement , 6 Cramps , 7 Gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0018-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0018-2)</PackageDescription>
<NDC11Code>55926-0018-02</NDC11Code>
<ProductNDC>55926-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Recharge Remedy No. 18</ProprietaryName>
<NonProprietaryName>Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of: 1 fatigue, 2 drowsiness, 3 inabilty to fall asleep, 4 sweet food cravings, 5 sudden drain of energy, 6 headaches, 7 nausea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0019-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0019-2)</PackageDescription>
<NDC11Code>55926-0019-02</NDC11Code>
<ProductNDC>55926-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Morale Remedy No. 19</ProprietaryName>
<NonProprietaryName>Anacardium Orientale, Aurum Metallicum, Calcarea Carbonica, Cimicifuga Racemosa, Hypericum Perforatum, Ignatia Amara, Kale Bromatum, Natrum Carbonicum, Natrum Sulphuricum, Phosphoricum Acidum, Phosphorus, Pulsatilla, Sepia, Tabacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>SEMECARPUS ANACARDIUM JUICE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; SODIUM CARBONATE; SODIUM SULFATE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOBACCO LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of: 1 mood swings, 2 despondency, 3 sadness, 4 introspection, 5 melancholy, 6 despair, 7 Hypersensitivity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0020-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0020-2)</PackageDescription>
<NDC11Code>55926-0020-02</NDC11Code>
<ProductNDC>55926-0020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothe Remedy No. 20</ProprietaryName>
<NonProprietaryName>Belladonna, Bryonia, Capsicum Annuum, Chininum Arsenicosum, Coffea Cruda, Gelsemium Sempervirens, Glonoinum, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Spigelia Anthelmia, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; QUININE ARSENITE; ARABICA COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of: 1 headache pain (throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occiptal, etc), 2 band feeling around the head, 3 morning headache, 4 sun headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0021-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0021-2)</PackageDescription>
<NDC11Code>55926-0021-02</NDC11Code>
<ProductNDC>55926-0021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Relieve Remedy No. 21</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cyclamen Europaeum, Helonias Dioica, Ignatia Amara, Lac Caninum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Platinum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>APIS MELLIFERA; MATRICARIA RECUTITA; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Temporarily relieves symptoms of PMS: 1 mood swings, 2 irritability, 3 water retention, 4 bloating, 5 cramping, 6 sensitive breasts, 7 sensitivity, 8 weariness, 9 weight gain, 10 swelling, 11 headaches.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0022-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0022-2)</PackageDescription>
<NDC11Code>55926-0022-02</NDC11Code>
<ProductNDC>55926-0022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Invigorate Male Remedy No. 22</ProprietaryName>
<NonProprietaryName>Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picricum Acidum, Selenium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: For temporary relief of: : 1 loss of sexual desire, 2 premature ejaculation, 3 infrequent erection, 4 sexual burnout, 5 low sex drive, 6 poor circulation, 7 lack of stamina.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0023-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (55926-0023-2)</PackageDescription>
<NDC11Code>55926-0023-02</NDC11Code>
<ProductNDC>55926-0023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Invigorate Female Remedy No. 23</ProprietaryName>
<NonProprietaryName>Agnus Castus, Aletris Farinosa, Berberis Vulgaris, Caulopyllum Thalictroides, Ferrum Metallicum, Graphites, Helonias Dioica, Ignatia Amara, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriaticum, Onosmodium Virginianum, Pulsatilla, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>CHASTE TREE; ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; IRON; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: For temporary relief of symptoms of low female sexual energy: 1 Decrease in sexual desire, 2 Decrease on responsiveness and enjoyment, 3 Feeling of fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0025-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (55926-0025-2) </PackageDescription>
<NDC11Code>55926-0025-02</NDC11Code>
<ProductNDC>55926-0025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Emuaidmax</ProprietaryName>
<NonProprietaryName>Silver</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140122</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>SILVER</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of these symptoms due to minor wounds and burns, bruises, ulcerations, sunburn, razor burn, scrapes, rashes, blisters, bug bites, and skin eruptions from acne, eczema, or minor infection: burning stinging itching redness stiffness minor pain minor inflammation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55926-0027-2</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (55926-0027-2) </PackageDescription>
<NDC11Code>55926-0027-02</NDC11Code>
<ProductNDC>55926-0027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Emuaidmax Concentrate</ProprietaryName>
<NonProprietaryName>Silver</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Speer Laboratories, LLC</LabelerName>
<SubstanceName>SILVER</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of these symptoms due to minor wounds and burns, bruises, ulcerations, sunburn, razor burn, scrapes, rashes, blisters, bug bites, and skin eruptions from acne, eczema, or minor infection: burning stinging itching redness stiffness minor pain minor inflammation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0024-5747-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0024-5747-02) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5747-02</NDC11Code>
<ProductNDC>0024-5747</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlyxin</ProprietaryName>
<NonProprietaryName>Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160727</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208471</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>LIXISENATIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5831-02</NDCCode>
<PackageDescription>2 INJECTION in 1 CARTON (0024-5831-02)</PackageDescription>
<NDC11Code>00024-5831-02</NDC11Code>
<ProductNDC>0024-5831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-5833-02</NDCCode>
<PackageDescription>2 INJECTION in 1 CARTON (0024-5833-02)</PackageDescription>
<NDC11Code>00024-5833-02</NDC11Code>
<ProductNDC>0024-5833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-5862-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00024-5862-01</NDC11Code>
<ProductNDC>0024-5862</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mozobil</ProprietaryName>
<NonProprietaryName>Plerixafor</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022311</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>PLERIXAFOR</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1.2mL</StrengthUnit>
<Pharm_Classes>Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).</IndicationAndUsage>
<Description>Mozobil (plerixafor) injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C28H54N8. The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula. Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1.</Description>
</NDC>
<NDC>
<NDCCode>0024-5871-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) </PackageDescription>
<NDC11Code>00024-5871-02</NDC11Code>
<ProductNDC>0024-5871</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo Max</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>0024-5901-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5901-02) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5901-02</NDC11Code>
<ProductNDC>0024-5901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0024-5902-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5902-02) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5902-02</NDC11Code>
<ProductNDC>0024-5902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0024-5903-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0024-5903-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5903-02</NDC11Code>
<ProductNDC>0024-5903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5904-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0024-5904-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5904-02</NDC11Code>
<ProductNDC>0024-5904</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5908-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5908-01) / 1.14 mL in 1 SYRINGE (0024-5908-00) </PackageDescription>
<NDC11Code>00024-5908-01</NDC11Code>
<ProductNDC>0024-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5908-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5908-02) / 1.14 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5908-02</NDC11Code>
<ProductNDC>0024-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5910-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5910-01) / 1.14 mL in 1 SYRINGE (0024-5910-00) </PackageDescription>
<NDC11Code>00024-5910-01</NDC11Code>
<ProductNDC>0024-5910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5910-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5910-02) / 1.14 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5910-02</NDC11Code>
<ProductNDC>0024-5910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0024-5911-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5911-02) / .67 mL in 1 SYRINGE, GLASS (0024-5911-00) </PackageDescription>
<NDC11Code>00024-5911-02</NDC11Code>
<ProductNDC>0024-5911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211020</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761055</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DUPILUMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/.67mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211020</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).</IndicationAndUsage>
<Description>Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.</Description>
</NDC>
<NDC>
<NDCCode>0024-5911-20</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5911-20) / .67 mL in 1 SYRINGE, GLASS (0024-5911-01) </PackageDescription>
<NDC11Code>00024-5911-20</NDC11Code>
<ProductNDC>0024-5911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dupixent</ProprietaryName>
<NonProprietaryName>Dupilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211020</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761055</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DUPILUMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/.67mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Interleukin 4 Receptor alpha Antagonists [MoA], Interleukin-4 Receptor alpha Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211020</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUPIXENT is an interleukin-4 receptor alpha antagonist indicated. Atopic Dermatitis. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1). Asthma. as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. (1.2). Chronic Rhinosinusitis with Nasal Polyps. as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.3). Eosinophilic Esophagitis. for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4). Prurigo Nodularis. for the treatment of adult patients with prurigo nodularis (PN). (1.5). Chronic Obstructive Pulmonary Disease. as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.6)Limitations of Use: Not for the relief of acute bronchospasm. (1.6). Chronic Spontaneous Urticaria. for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (1.7). Limitations of Use: Not indicated for other forms of urticaria. (1.7). Bullous Pemphigoid. for the treatment of adult patients with bullous pemphigoid (BP). (1.8). Allergic Fungal Rhinosinusitis. for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. (1.9).</IndicationAndUsage>
<Description>Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa. Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex. Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9. Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.</Description>
</NDC>
</NDCList>