{
"NDC": [
{
"NDCCode": "59985-323-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-323-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0323-32",
"ProductNDC": "59985-323",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Diminish Gluten Reactivity",
"NonProprietaryName": "Anatherum Muricatum, Avena Sativa, Arsenicum Album, Berberis Vulgaris, Dioscorea Villosa, Okoubaka Aubrevillei",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CHRYSOPOGON ZIZANIOIDES ROOT; DIOSCOREA VILLOSA TUBER; OKOUBAKA AUBREVILLEI BARK",
"StrengthNumber": "30; 30; 6; 30; 6; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves the symptoms of abdominal pain, discomfort, gas and bloating following consumption of gluten and grains."
},
{
"NDCCode": "69230-323-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (69230-323-01) / 10 TABLET in 1 BLISTER PACK (69230-323-32) ",
"NDC11Code": "69230-0323-01",
"ProductNDC": "69230-323",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211718",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
},
{
"NDCCode": "59985-300-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-300-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0300-32",
"ProductNDC": "59985-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Allergy Mold, Dust And Hay",
"NonProprietaryName": "Bovista Lycoperdon, Secale Cornutum, Ustilago Maydis, Wyethia Helenioides",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CLAVICEPS PURPUREA SCLEROTIUM; LYCOPERDON UTRIFORME FRUITING BODY; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT",
"StrengthNumber": "6; 30; 12; 12",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Mold, dust & hay spritz helpful for relief of allergy symptoms - sneezing, itching, dullness, stuffy head, runny eyes & sinuses."
},
{
"NDCCode": "59985-301-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-301-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0301-32",
"ProductNDC": "59985-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Anti-septic Cuts And Scrapes",
"NonProprietaryName": "Baptisia Tinctoria, Echinacea Purpurea, Nitricum Acidum, Thuja Occidentalis, Calendula Officinalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "BAPTISIA TINCTORIA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA WHOLE; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6; 30; 30; 6; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Speed healing of cuts, scrapes and pain. Diminishes scars. Contains a natural antiseptic."
},
{
"NDCCode": "59985-305-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-305-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0305-32",
"ProductNDC": "59985-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Burn Relief",
"NonProprietaryName": "Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria, Utrica Urens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA; URTICA URENS WHOLE",
"StrengthNumber": "30; 30; 30; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!."
},
{
"NDCCode": "59985-310-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-310-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0310-32",
"ProductNDC": "59985-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Irritable Eye Relief",
"NonProprietaryName": "Aluminum Oxide, Amylenum Nitrosum, Argentum Nitricum, Arsenicum Iodatum, Calendula Officinalis, Conium Maculatum, Euphrasia Officinalis, Physostigma Venenosum, Ruta Graveolens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ALUMINUM OXIDE; AMYL NITRITE; ARSENIC TRIIODIDE; CALENDULA OFFICINALIS FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE",
"StrengthNumber": "6; 6; 6; 30; 6; 6; 6; 30; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Diminishes red, irritated, itchy dry eyes, discharge, eye fatigue, reading and computer strain."
},
{
"NDCCode": "59985-315-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-315-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0315-32",
"ProductNDC": "59985-315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Sunburn Relief",
"NonProprietaryName": "Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA",
"StrengthNumber": "30; 30; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Use orally and or topically for scarring, pain, blistering. Reduces peeling. FAST RELIEF!."
},
{
"NDCCode": "59985-322-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-322-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0322-32",
"ProductNDC": "59985-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Antihistamine Action",
"NonProprietaryName": "Apis Mellifica, Ledum Palustre, Vespa Crabro, Histamine, Cresolum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "APIS MELLIFERA; CRESOL; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO",
"StrengthNumber": "30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For red, hot, stinging, intense, itching allergy symptoms including bites, punctures, and hives."
},
{
"NDCCode": "59985-324-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-324-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0324-32",
"ProductNDC": "59985-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Mineral Absorption",
"NonProprietaryName": "Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Calcarea Sulphurica, Cuprum Metallicum, Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Iodium Purum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Sulphuricum, Selenium Metallicum, Silicea",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; COPPER; DIBASIC POTASSIUM PHOSPHATE; FERRIC PHOSPHATE; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SELENIUM; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Iron [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Facilitate the use of 16 minerals from your food and expensive supplements to maximize your investment. Minimizes leg cramps."
},
{
"NDCCode": "24478-323-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (24478-323-05) / 150 mL in 1 BOTTLE",
"NDC11Code": "24478-0323-05",
"ProductNDC": "24478-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quillivant",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202100",
"LabelerName": "NextWave Pharmaceuticals, Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/150mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121001",
"SamplePackage": "N",
"IndicationAndUsage": "QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR contains in each 1 mL the equivalent of 5 mg of methylphenidate hydrochloride, present as methylphenidate (4.32 mg) complexed with sodium polystyrene sulfonate. Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate structure. C14H19NO2 Mol. Wt. 233.31. QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide."
},
{
"NDCCode": "59985-101-11",
"PackageDescription": "28.35 g in 1 JAR (59985-101-11) ",
"NDC11Code": "59985-0101-11",
"ProductNDC": "59985-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Turbo Arnica",
"ProprietaryNameSuffix": "Cream",
"NonProprietaryName": "Arnica Montana Hpus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARNICA MONTANA WHOLE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/28.35g",
"Status": "Deprecated",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141001",
"SamplePackage": "N",
"IndicationAndUsage": "Used for injuries, sprains, sore muscles."
},
{
"NDCCode": "59985-103-12",
"PackageDescription": "1 JAR in 1 BOX (59985-103-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0103-12",
"ProductNDC": "59985-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Bug Bite Cream",
"NonProprietaryName": "Apis Mellifica, Ledum Palustre, Histamine, Vespa Crabro, Calendula Officinalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "APIS MELLIFERA; CALENDULA OFFICINALIS FLOWERING TOP; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO",
"StrengthNumber": "30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For bites, stings, hives, diminishing swelling, pain and itching from bees, wasps, and mosquitoes. KIDS FAVORITE!."
},
{
"NDCCode": "59985-105-12",
"PackageDescription": "1 JAR in 1 BOX (59985-105-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0105-12",
"ProductNDC": "59985-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Calendula Cream",
"NonProprietaryName": "Calendula Officinalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Speed healing of wounds, sores, acne sores and lips. Reduces scarring."
},
{
"NDCCode": "59985-108-12",
"PackageDescription": "1 JAR in 1 BOX (59985-108-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0108-12",
"ProductNDC": "59985-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Blistering Relief Cream",
"NonProprietaryName": "Cantharis Vesicatoria, Chocolate, Calendula Officinalis, Natrum Muriaticum, Echinacea Angustifolia",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; COCOA; ECHINACEA ANGUSTIFOLIA WHOLE; LYTTA VESICATORIA; SODIUM CHLORIDE",
"StrengthNumber": "30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For pain relief and accelerated healing of all blistering outbreaks around mouth and on lips/genitals."
},
{
"NDCCode": "59985-109-12",
"PackageDescription": "1 JAR in 1 BOX (59985-109-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0109-12",
"ProductNDC": "59985-109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Irritable Skin Cream",
"NonProprietaryName": "Calcarea Sulphurica, Calendula Officinalis, Graphites Naturalis, Nux Vomica, Cresolum, Thuja Occidentalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALCIUM SULFATE ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; CRESOL; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "30; 30; 6; 30; 6; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Relief for dry, cracking, miserable skin ailments. Use to facilitate healing of psoriasis and eczema."
},
{
"NDCCode": "59985-113-12",
"PackageDescription": "1 JAR in 1 BOX (59985-113-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0113-12",
"ProductNDC": "59985-113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Spider Bite Cream",
"NonProprietaryName": "Carbo Animalis, Alcoholus, Loxosceles Reclusa, Lachesis Mutus, Hamamelis Virginiana, Calendula Officinalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ALCOHOL; CALENDULA OFFICINALIS FLOWERING TOP; CARBO ANIMALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LOXOSCELES RECLUSA",
"StrengthNumber": "30; 30; 30; 30; 12; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "This remedy has affinity for minimizing the poisoning effect and diminishing the potential tissue damage allowing the wound to heal."
},
{
"NDCCode": "59985-114-12",
"PackageDescription": "1 JAR in 1 BOX (59985-114-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0114-12",
"ProductNDC": "59985-114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Sports Injury Cream",
"NonProprietaryName": "Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Staphysagria, Calcarea Phosphorica",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM WHOLE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "To diminish pain and inflammation of muscle, tendon, ligament, puncture wounds and bone injuries, including surgery, P.T., sports injuries and dentistry."
},
{
"NDCCode": "59985-118-12",
"PackageDescription": "1 JAR in 1 BOX (59985-118-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0118-12",
"ProductNDC": "59985-118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Arnica Cream",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARNICA MONTANA WHOLE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Higher potency, significantly faster acting than most creams on the market. For sore muscles, sprains, bruising & injuries. (Use Calendula on. open sores.)."
},
{
"NDCCode": "59985-217-22",
"PackageDescription": "100 PELLET in 1 DRUM (59985-217-22) ",
"NDC11Code": "59985-0217-22",
"ProductNDC": "59985-217",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Turbo Travel Sickness",
"ProprietaryNameSuffix": "Relief",
"NonProprietaryName": "Tabacum, Hpus,cocculus, Hpus,ipecacuanha, Hpus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "IPECAC; JATEORHIZA CALUMBA ROOT; TOBACCO LEAF",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140110",
"SamplePackage": "N",
"IndicationAndUsage": "Alleviate symptoms of travel sickness."
},
{
"NDCCode": "59985-611-61",
"PackageDescription": "46 VIAL, GLASS in 1 CASE (59985-611-61) / 100 PELLET in 1 VIAL, GLASS (59985-611-20) ",
"NDC11Code": "59985-0611-61",
"ProductNDC": "59985-611",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family I",
"ProprietaryNameSuffix": "Kit",
"NonProprietaryName": "30c Homeopathic Kit",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151230",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; ACTIVATED CHARCOAL; ALUMINUM OXIDE; ANAMIRTA COCCULUS SEED; ANTIMONY POTASSIUM TARTRATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA WHOLE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; DROSERA ROTUNDIFOLIA WHOLE; EUPHRASIA STRICTA; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM WHOLE; IPECAC; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA WHOLE; MERCURIC CHLORIDE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; RANCID BEEF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151230",
"SamplePackage": "N",
"IndicationAndUsage": "Aconite (Fright) First remedy used for a cold when exposed to cold weather or wind. Like fear of flying, fear following a frightful event or shock. Alumina (Dryness) Dryness of stool, skin, mouth, eyes, vagina, etc. Ant Crud (Skin Cracks and Roughness) Roughness and cracks in nose and mouth, excessive appetite, warts, nausea, vomiting from overeating, sunstroke. Ant Tart (Rattling Chest) Cold, flu, elderly, small children, birthing. Cough remaining following the flu, blue babies, pneumonia-like symptoms. Apis (Bees) Red, hot, puffy, swollen, kidney edema. Feels like stinging pain; very tender and intolerant of heat, (sunburn, minor allergic reactions). Has an antihistamine action. Arg Nit (Exploding) Headache, anxiety, sugar cravings, especially chocolate. Constant throat clearing. Always in a hurry, insomnia with thoughts stuck over and over in head. Gas and bloating pressure. Arnica (Bruised) Accidental blows, sprains, bruised feeling, overwork of muscles, head injury, strokes. Also in cream. For broken skin, use orally and go to calendula cream as an antiseptic topically. Arsenicum (Poisoning) Vomiting, diarrhea as if had eaten rotten food. Burning pains with restlessness, worse at midnight. Dislike being alone. When ill, say “I feel like I’m going to die.”. Belladonna (Violent) Red, hot, throbbing. So violent in nature you need to transport to hospital. Give remedy during transport. High Fevers, pain of horrible things like migraines and appendicitis. Bryonia (Worsened by any movement) Back pain, migraine-worse even for eye movement. Patient says “Don’t touch me!”. Calendula This flower, as a remedy, is VERY FAST acting. Healing of internal and external ulcerations. Used to wash wounds and promote accelerated healing. Available as pellets, cream and tonic. Cantharis (Burns) Burning on skin, burning urination, great for sunburns too. Take orally and apply Calendula to skin. Spritz available. Carbo Veg (Reviver) Cold, clammy, gasping for air, needs to be fanned, runs to open window to breathe. General indigestion from milk or fatty foods. Faint and cold. Also, cleanse for fumes. Chamomilla (Angry Fits) Irritable “as if” too much coffee, cranky like teething baby. Nothing pleases them during anger. Wants something and then pushes it away. Over sensitive to pain. Baby colic of angry mother! Ear infections and childhood ailments. China O (Malaria) Debility from loss of fluids like heavy menses, prolonged diarrhea, fever with sweats and chills, giving blood. Returns vitality. It is also useful in ringing of the ear and faintness. Cocculus (Nurses Remedy) Debility and sleeplessness from caring for others, especially relatives. Sleeplessness, rolling over in bed, jet lag. Dizziness and car sickness, as if drunk. Coffea Cruda (Jittery) “As if” too much caffeine. Sleeplessness from being over excited like kids at Christmas or day before vacation. If jittery literally from caffeine, take Nux Vomica or Chamomilla. Colocynthis (Colic) Better for bending double (babies draw knees up). Cramp like abdominal pains, vomiting, relieved by applying pressure and leaning forward. Gall bladder-like symptoms. Drosera (Cough until you gag!) Whooping cough. Spasms or cough so hard it can induce vomiting sticky mucus. Feels trapped. Euphrasia (Eyebrite) Great for eye redness (pink eye), hay fever, and allergies. Ferr Phos (Iron) First remedy for fever of unknown origin, bloody nosed, heavy periods, tiredness from iron-poor blood.*If fevers don’t respond, go to Aconite or Belladonna. Gelsemium (Yellow) First remedy for flu with yellow discharge, nervous, weak, shivering, restless with frequent urination. Performance anxiety with frequent urination or diarrhea proceeding. DT’s (withdrawals). Hepar Sulph (Infections) Green, thick mucus of children, ear infection start in left and go to right, sore throat as if a splinter, boils, acne, etc. Histaminum General itchy allergies of eyes and skin, general inflammations and hives. Hypericum (Nerve Pain) Pain of a smashed finger (like in a door!); shooting pains, pains of dental work. Ignatia (Hysterical) Helpful for funerals and grief from unexpected events. Ailments from disappointments in love and circumstances. Helps to think clearly. Ipecacuaha (Nausea) Sick feeling not relieved by vomiting. May appear with other symptoms of flu or pregnancy. Also, great for flu with cough. Kali Bi First remedy for sinus infection with sticky stingy discharge. Headache between brows. Ledum (Homeopathic Tetanus) Pain and infection of puncture wounds. Punctures include insect bites! (Wounds may feel cold and pain is relieved by cold.) Never well since puncture like allergy shots, diabetes pricking frequently. Tetanus nosode also available. Lycopodium (Bullied or the bully) Milk aggravates digestion. Patient avoids beans and cabbage family vegetables to diminish embarrassment of gas and bloating. Flatulence worse between 4-8 pm. Great remedy for hernia. Mag Phos (Cramps and Bleeding) General cramps and spasms of menses, leg and feet, better with heading pad, bath or massage. Bloody noses. Mercury (infections) Abscesses in bone and nails, teeth infected, strep-throats, wetness, sweat or drool always present – profuse salvation. Sensitive to heat and cold, like a thermometer. Nat Mur Indicated for coughing on attempting to speak. Good menopausal remedy. (See Ars and Alum or vaginally dry.). Nux Vomica (Business men’s remedy) Not limited to males. Pain as if hangover, overworked, rushed, perfectionism, eating poorly. Excessive coffee, fast food, demanding, cranky and all the ailments of the 20th Century lifestyle; heartburn, hemorrhoids, cranky indigestion results. Phosphorus (Cough) Rare symptoms when ill. Cold that quickly goes to the chest. Bloody discharges, bloody noses. Hoarseness, dry, hard cough with fever, develops quickly from a cold setting in the chest. Patient craves cold drinks. People who love attention!. Pulsatilla(Common Child’s Remedy) Ailments of children who are comforted being held. Changeable symptoms with weariness. Better in fresh air. Sick from rich and fried foods. Needy girls. Good PMS remedy. Need to be in a group, yielding personality. Pyrogenium (Sepsis) Infections that look scary- high fever with rapid pulse- poisoning. When other infection remedies not effective. Any discharges with odor of rotting meat (abscess, sinus infections, etc.). Rhus Tox (Tin Man) Achy joints worse in storms or drop in barometer. Itchy skin eruptions; better bathing and better heat (when worse bathing, see Sulfur). Ruta (Tendon Injuries) Soreness of tendons from injury or overuse. Tired eyes from reading or computer work. Carpel tunnel syndrome. Silicea (Removes Foreign Bodies) For splinters under fingernails, to remove dirt from a wound, promote suppuration of abscess. Silicea will surround foreign body with fluid and bring to the surface. Thin hair and nails – defective nutritional assimilation. Spongia Tosta (Coughs) Worse wind-dry barking cough, cough better with warm drinks, cardiac cough. Hoarseness, dry, burning constriction feeling. Staphysagria The most indicated remedy after surgery to heal the incision and diminish chance of infection. Burning urination following new partner. (Honeymoon cystitis). Infection from others. Sulfur (Skin Remedy) Dry skin eruptions, worse with heat of bed or shower. Hot flashes, sinus infections, yellow discharges. Symphytum (Bone Knit) For broken bones once set by physician. Tabacum (Turning Green) Nausea and vomiting with dizziness, spinning, motion sickness; better for closing eyes. Vertigo with anxiety. Verat A (Purging) Vomiting and diarrhea at the same time with cold sweats and extreme exhaustion. Have to decide which end to put on the potty first. For flu, food poisoning or bad water."
},
{
"NDCCode": "0069-0235-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0235-30) ",
"NDC11Code": "00069-0235-30",
"ProductNDC": "0069-0235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cibinqo",
"NonProprietaryName": "Abrocitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213871",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "ABROCITINIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use. CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.",
"Description": "CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration. Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide. The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC. Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is. Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "0069-0335-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30) ",
"NDC11Code": "00069-0335-30",
"ProductNDC": "0069-0335",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cibinqo",
"NonProprietaryName": "Abrocitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213871",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "ABROCITINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use. CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.",
"Description": "CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration. Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide. The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC. Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is. Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "0069-0435-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0435-30) ",
"NDC11Code": "00069-0435-30",
"ProductNDC": "0069-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cibinqo",
"NonProprietaryName": "Abrocitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213871",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "ABROCITINIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use. CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.",
"Description": "CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration. Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide. The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC. Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is. Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "0069-3220-66",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0069-3220-66) ",
"NDC11Code": "00069-3220-66",
"ProductNDC": "0069-3220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feldene",
"NonProprietaryName": "Piroxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940525",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018147",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "PIROXICAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19940525",
"SamplePackage": "N",
"IndicationAndUsage": "FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch."
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{
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"PackageDescription": "100 CAPSULE in 1 BOTTLE (0069-3230-66) ",
"NDC11Code": "00069-3230-66",
"ProductNDC": "0069-3230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feldene",
"NonProprietaryName": "Piroxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940525",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018147",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
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"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19940525",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch."
},
{
"NDCCode": "0093-3098-29",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (0093-3098-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) ",
"NDC11Code": "00093-3098-29",
"ProductNDC": "0093-3098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077132",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISEDRONATE SODIUM MONOHYDRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80."
},
{
"NDCCode": "0093-3098-44",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) ",
"NDC11Code": "00093-3098-44",
"ProductNDC": "0093-3098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077132",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISEDRONATE SODIUM MONOHYDRATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80."
},
{
"NDCCode": "0093-3099-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-3099-56) ",
"NDC11Code": "00093-3099-56",
"ProductNDC": "0093-3099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
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"ApplicationNumber": "ANDA077132",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISEDRONATE SODIUM MONOHYDRATE",
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"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": "Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80."
},
{
"NDCCode": "0093-3100-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-3100-56) ",
"NDC11Code": "00093-3100-56",
"ProductNDC": "0093-3100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077132",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80."
},
{
"NDCCode": "0093-7771-13",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0093-7771-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19) ",
"NDC11Code": "00093-7771-13",
"ProductNDC": "0093-7771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079215",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "N",
"IndicationAndUsage": "Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate Sodium Tablets USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Risedronate Sodium Tablet USP for oral administration contains the equivalent of 150 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinized corn starch, sodium stearyl fumarate, talc and titanium dioxide."
}
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}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!.</IndicationAndUsage>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ALUMINUM OXIDE; AMYL NITRITE; ARSENIC TRIIODIDE; CALENDULA OFFICINALIS FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 30; 6; 6; 6; 30; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diminishes red, irritated, itchy dry eyes, discharge, eye fatigue, reading and computer strain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-315-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-315-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0315-32</NDC11Code>
<ProductNDC>59985-315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Sunburn Relief</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA</SubstanceName>
<StrengthNumber>30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use orally and or topically for scarring, pain, blistering. Reduces peeling. FAST RELIEF!.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-322-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-322-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0322-32</NDC11Code>
<ProductNDC>59985-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Antihistamine Action</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifica, Ledum Palustre, Vespa Crabro, Histamine, Cresolum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>APIS MELLIFERA; CRESOL; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For red, hot, stinging, intense, itching allergy symptoms including bites, punctures, and hives.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-324-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-324-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0324-32</NDC11Code>
<ProductNDC>59985-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Mineral Absorption</ProprietaryNameSuffix>
<NonProprietaryName>Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Calcarea Sulphurica, Cuprum Metallicum, Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Iodium Purum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Sulphuricum, Selenium Metallicum, Silicea</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; COPPER; DIBASIC POTASSIUM PHOSPHATE; FERRIC PHOSPHATE; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SELENIUM; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Iron [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Facilitate the use of 16 minerals from your food and expensive supplements to maximize your investment. Minimizes leg cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24478-323-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24478-323-05) / 150 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>24478-0323-05</NDC11Code>
<ProductNDC>24478-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quillivant</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202100</ApplicationNumber>
<LabelerName>NextWave Pharmaceuticals, Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/150mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR contains in each 1 mL the equivalent of 5 mg of methylphenidate hydrochloride, present as methylphenidate (4.32 mg) complexed with sodium polystyrene sulfonate. Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate structure. C14H19NO2 Mol. Wt. 233.31. QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59985-101-11</NDCCode>
<PackageDescription>28.35 g in 1 JAR (59985-101-11) </PackageDescription>
<NDC11Code>59985-0101-11</NDC11Code>
<ProductNDC>59985-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Turbo Arnica</ProprietaryName>
<ProprietaryNameSuffix>Cream</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana Hpus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARNICA MONTANA WHOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/28.35g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Used for injuries, sprains, sore muscles.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-103-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-103-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0103-12</NDC11Code>
<ProductNDC>59985-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Bug Bite Cream</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifica, Ledum Palustre, Histamine, Vespa Crabro, Calendula Officinalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>APIS MELLIFERA; CALENDULA OFFICINALIS FLOWERING TOP; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For bites, stings, hives, diminishing swelling, pain and itching from bees, wasps, and mosquitoes. KIDS FAVORITE!.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-105-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-105-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0105-12</NDC11Code>
<ProductNDC>59985-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Calendula Cream</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Speed healing of wounds, sores, acne sores and lips. Reduces scarring.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-108-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-108-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0108-12</NDC11Code>
<ProductNDC>59985-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Blistering Relief Cream</ProprietaryNameSuffix>
<NonProprietaryName>Cantharis Vesicatoria, Chocolate, Calendula Officinalis, Natrum Muriaticum, Echinacea Angustifolia</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; COCOA; ECHINACEA ANGUSTIFOLIA WHOLE; LYTTA VESICATORIA; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For pain relief and accelerated healing of all blistering outbreaks around mouth and on lips/genitals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-109-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-109-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0109-12</NDC11Code>
<ProductNDC>59985-109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Irritable Skin Cream</ProprietaryNameSuffix>
<NonProprietaryName>Calcarea Sulphurica, Calendula Officinalis, Graphites Naturalis, Nux Vomica, Cresolum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALCIUM SULFATE ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; CRESOL; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>30; 30; 6; 30; 6; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relief for dry, cracking, miserable skin ailments. Use to facilitate healing of psoriasis and eczema.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-113-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-113-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0113-12</NDC11Code>
<ProductNDC>59985-113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Spider Bite Cream</ProprietaryNameSuffix>
<NonProprietaryName>Carbo Animalis, Alcoholus, Loxosceles Reclusa, Lachesis Mutus, Hamamelis Virginiana, Calendula Officinalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ALCOHOL; CALENDULA OFFICINALIS FLOWERING TOP; CARBO ANIMALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LOXOSCELES RECLUSA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 12; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This remedy has affinity for minimizing the poisoning effect and diminishing the potential tissue damage allowing the wound to heal.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-114-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-114-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0114-12</NDC11Code>
<ProductNDC>59985-114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Sports Injury Cream</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Staphysagria, Calcarea Phosphorica</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM WHOLE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To diminish pain and inflammation of muscle, tendon, ligament, puncture wounds and bone injuries, including surgery, P.T., sports injuries and dentistry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-118-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-118-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0118-12</NDC11Code>
<ProductNDC>59985-118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Arnica Cream</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARNICA MONTANA WHOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Higher potency, significantly faster acting than most creams on the market. For sore muscles, sprains, bruising & injuries. (Use Calendula on. open sores.).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-217-22</NDCCode>
<PackageDescription>100 PELLET in 1 DRUM (59985-217-22) </PackageDescription>
<NDC11Code>59985-0217-22</NDC11Code>
<ProductNDC>59985-217</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Turbo Travel Sickness</ProprietaryName>
<ProprietaryNameSuffix>Relief</ProprietaryNameSuffix>
<NonProprietaryName>Tabacum, Hpus,cocculus, Hpus,ipecacuanha, Hpus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>IPECAC; JATEORHIZA CALUMBA ROOT; TOBACCO LEAF</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alleviate symptoms of travel sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-611-61</NDCCode>
<PackageDescription>46 VIAL, GLASS in 1 CASE (59985-611-61) / 100 PELLET in 1 VIAL, GLASS (59985-611-20) </PackageDescription>
<NDC11Code>59985-0611-61</NDC11Code>
<ProductNDC>59985-611</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family I</ProprietaryName>
<ProprietaryNameSuffix>Kit</ProprietaryNameSuffix>
<NonProprietaryName>30c Homeopathic Kit</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151230</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; ACTIVATED CHARCOAL; ALUMINUM OXIDE; ANAMIRTA COCCULUS SEED; ANTIMONY POTASSIUM TARTRATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA WHOLE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; DROSERA ROTUNDIFOLIA WHOLE; EUPHRASIA STRICTA; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM WHOLE; IPECAC; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA WHOLE; MERCURIC CHLORIDE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; RANCID BEEF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aconite (Fright) First remedy used for a cold when exposed to cold weather or wind. Like fear of flying, fear following a frightful event or shock. Alumina (Dryness) Dryness of stool, skin, mouth, eyes, vagina, etc. Ant Crud (Skin Cracks and Roughness) Roughness and cracks in nose and mouth, excessive appetite, warts, nausea, vomiting from overeating, sunstroke. Ant Tart (Rattling Chest) Cold, flu, elderly, small children, birthing. Cough remaining following the flu, blue babies, pneumonia-like symptoms. Apis (Bees) Red, hot, puffy, swollen, kidney edema. Feels like stinging pain; very tender and intolerant of heat, (sunburn, minor allergic reactions). Has an antihistamine action. Arg Nit (Exploding) Headache, anxiety, sugar cravings, especially chocolate. Constant throat clearing. Always in a hurry, insomnia with thoughts stuck over and over in head. Gas and bloating pressure. Arnica (Bruised) Accidental blows, sprains, bruised feeling, overwork of muscles, head injury, strokes. Also in cream. For broken skin, use orally and go to calendula cream as an antiseptic topically. Arsenicum (Poisoning) Vomiting, diarrhea as if had eaten rotten food. Burning pains with restlessness, worse at midnight. Dislike being alone. When ill, say “I feel like I’m going to die.”. Belladonna (Violent) Red, hot, throbbing. So violent in nature you need to transport to hospital. Give remedy during transport. High Fevers, pain of horrible things like migraines and appendicitis. Bryonia (Worsened by any movement) Back pain, migraine-worse even for eye movement. Patient says “Don’t touch me!”. Calendula This flower, as a remedy, is VERY FAST acting. Healing of internal and external ulcerations. Used to wash wounds and promote accelerated healing. Available as pellets, cream and tonic. Cantharis (Burns) Burning on skin, burning urination, great for sunburns too. Take orally and apply Calendula to skin. Spritz available. Carbo Veg (Reviver) Cold, clammy, gasping for air, needs to be fanned, runs to open window to breathe. General indigestion from milk or fatty foods. Faint and cold. Also, cleanse for fumes. Chamomilla (Angry Fits) Irritable “as if” too much coffee, cranky like teething baby. Nothing pleases them during anger. Wants something and then pushes it away. Over sensitive to pain. Baby colic of angry mother! Ear infections and childhood ailments. China O (Malaria) Debility from loss of fluids like heavy menses, prolonged diarrhea, fever with sweats and chills, giving blood. Returns vitality. It is also useful in ringing of the ear and faintness. Cocculus (Nurses Remedy) Debility and sleeplessness from caring for others, especially relatives. Sleeplessness, rolling over in bed, jet lag. Dizziness and car sickness, as if drunk. Coffea Cruda (Jittery) “As if” too much caffeine. Sleeplessness from being over excited like kids at Christmas or day before vacation. If jittery literally from caffeine, take Nux Vomica or Chamomilla. Colocynthis (Colic) Better for bending double (babies draw knees up). Cramp like abdominal pains, vomiting, relieved by applying pressure and leaning forward. Gall bladder-like symptoms. Drosera (Cough until you gag!) Whooping cough. Spasms or cough so hard it can induce vomiting sticky mucus. Feels trapped. Euphrasia (Eyebrite) Great for eye redness (pink eye), hay fever, and allergies. Ferr Phos (Iron) First remedy for fever of unknown origin, bloody nosed, heavy periods, tiredness from iron-poor blood.*If fevers don’t respond, go to Aconite or Belladonna. Gelsemium (Yellow) First remedy for flu with yellow discharge, nervous, weak, shivering, restless with frequent urination. Performance anxiety with frequent urination or diarrhea proceeding. DT’s (withdrawals). Hepar Sulph (Infections) Green, thick mucus of children, ear infection start in left and go to right, sore throat as if a splinter, boils, acne, etc. Histaminum General itchy allergies of eyes and skin, general inflammations and hives. Hypericum (Nerve Pain) Pain of a smashed finger (like in a door!); shooting pains, pains of dental work. Ignatia (Hysterical) Helpful for funerals and grief from unexpected events. Ailments from disappointments in love and circumstances. Helps to think clearly. Ipecacuaha (Nausea) Sick feeling not relieved by vomiting. May appear with other symptoms of flu or pregnancy. Also, great for flu with cough. Kali Bi First remedy for sinus infection with sticky stingy discharge. Headache between brows. Ledum (Homeopathic Tetanus) Pain and infection of puncture wounds. Punctures include insect bites! (Wounds may feel cold and pain is relieved by cold.) Never well since puncture like allergy shots, diabetes pricking frequently. Tetanus nosode also available. Lycopodium (Bullied or the bully) Milk aggravates digestion. Patient avoids beans and cabbage family vegetables to diminish embarrassment of gas and bloating. Flatulence worse between 4-8 pm. Great remedy for hernia. Mag Phos (Cramps and Bleeding) General cramps and spasms of menses, leg and feet, better with heading pad, bath or massage. Bloody noses. Mercury (infections) Abscesses in bone and nails, teeth infected, strep-throats, wetness, sweat or drool always present – profuse salvation. Sensitive to heat and cold, like a thermometer. Nat Mur Indicated for coughing on attempting to speak. Good menopausal remedy. (See Ars and Alum or vaginally dry.). Nux Vomica (Business men’s remedy) Not limited to males. Pain as if hangover, overworked, rushed, perfectionism, eating poorly. Excessive coffee, fast food, demanding, cranky and all the ailments of the 20th Century lifestyle; heartburn, hemorrhoids, cranky indigestion results. Phosphorus (Cough) Rare symptoms when ill. Cold that quickly goes to the chest. Bloody discharges, bloody noses. Hoarseness, dry, hard cough with fever, develops quickly from a cold setting in the chest. Patient craves cold drinks. People who love attention!. Pulsatilla(Common Child’s Remedy) Ailments of children who are comforted being held. Changeable symptoms with weariness. Better in fresh air. Sick from rich and fried foods. Needy girls. Good PMS remedy. Need to be in a group, yielding personality. Pyrogenium (Sepsis) Infections that look scary- high fever with rapid pulse- poisoning. When other infection remedies not effective. Any discharges with odor of rotting meat (abscess, sinus infections, etc.). Rhus Tox (Tin Man) Achy joints worse in storms or drop in barometer. Itchy skin eruptions; better bathing and better heat (when worse bathing, see Sulfur). Ruta (Tendon Injuries) Soreness of tendons from injury or overuse. Tired eyes from reading or computer work. Carpel tunnel syndrome. Silicea (Removes Foreign Bodies) For splinters under fingernails, to remove dirt from a wound, promote suppuration of abscess. Silicea will surround foreign body with fluid and bring to the surface. Thin hair and nails – defective nutritional assimilation. Spongia Tosta (Coughs) Worse wind-dry barking cough, cough better with warm drinks, cardiac cough. Hoarseness, dry, burning constriction feeling. Staphysagria The most indicated remedy after surgery to heal the incision and diminish chance of infection. Burning urination following new partner. (Honeymoon cystitis). Infection from others. Sulfur (Skin Remedy) Dry skin eruptions, worse with heat of bed or shower. Hot flashes, sinus infections, yellow discharges. Symphytum (Bone Knit) For broken bones once set by physician. Tabacum (Turning Green) Nausea and vomiting with dizziness, spinning, motion sickness; better for closing eyes. Vertigo with anxiety. Verat A (Purging) Vomiting and diarrhea at the same time with cold sweats and extreme exhaustion. Have to decide which end to put on the potty first. For flu, food poisoning or bad water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-0235-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-0235-30) </PackageDescription>
<NDC11Code>00069-0235-30</NDC11Code>
<ProductNDC>0069-0235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cibinqo</ProprietaryName>
<NonProprietaryName>Abrocitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213871</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>ABROCITINIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use. CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.</IndicationAndUsage>
<Description>CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration. Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide. The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC. Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is. Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0069-0335-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30) </PackageDescription>
<NDC11Code>00069-0335-30</NDC11Code>
<ProductNDC>0069-0335</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cibinqo</ProprietaryName>
<NonProprietaryName>Abrocitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213871</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>ABROCITINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use. CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.</IndicationAndUsage>
<Description>CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration. Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide. The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC. Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is. Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0069-0435-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-0435-30) </PackageDescription>
<NDC11Code>00069-0435-30</NDC11Code>
<ProductNDC>0069-0435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cibinqo</ProprietaryName>
<NonProprietaryName>Abrocitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213871</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>ABROCITINIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use. CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.</IndicationAndUsage>
<Description>CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration. Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide. The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC. Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is. Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0069-3220-66</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0069-3220-66) </PackageDescription>
<NDC11Code>00069-3220-66</NDC11Code>
<ProductNDC>0069-3220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feldene</ProprietaryName>
<NonProprietaryName>Piroxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940525</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018147</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>PIROXICAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.</Description>
</NDC>
<NDC>
<NDCCode>0069-3230-66</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0069-3230-66) </PackageDescription>
<NDC11Code>00069-3230-66</NDC11Code>
<ProductNDC>0069-3230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feldene</ProprietaryName>
<NonProprietaryName>Piroxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940525</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018147</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>PIROXICAM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19940525</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.</Description>
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<NDCCode>0093-3098-29</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (0093-3098-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) </PackageDescription>
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<ApplicationNumber>ANDA077132</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISEDRONATE SODIUM MONOHYDRATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2026-04-30</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).</IndicationAndUsage>
<Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80.</Description>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) </PackageDescription>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).</IndicationAndUsage>
<Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).</IndicationAndUsage>
<Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80.</Description>
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<ProductNDC>0093-3100</ProductNDC>
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<StrengthUnit>mg/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).</IndicationAndUsage>
<Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>0093-7771-13</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0093-7771-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19) </PackageDescription>
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<StartMarketingDate>20161128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079215</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISEDRONATE SODIUM MONOHYDRATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).</IndicationAndUsage>
<Description>Risedronate Sodium Tablets USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Risedronate Sodium Tablet USP for oral administration contains the equivalent of 150 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinized corn starch, sodium stearyl fumarate, talc and titanium dioxide.</Description>
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