{
"NDC": [
{
"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": "31722-310-32",
"PackageDescription": "25 VIAL, GLASS in 1 BOX (31722-310-32) / 4 mL in 1 VIAL, GLASS (31722-310-31) ",
"NDC11Code": "31722-0310-32",
"ProductNDC": "31722-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217557",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema:Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 5-(aminosulfonyl)-4-chloro-2-[(2-furanylmethyl)amino] Benzoic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, freely soluble in acetone, in dimethyl formamide and in solutions of alkali hydroxides. Soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform. The structural formula is as follows:. C 12H 11C1N 2O 5S M.W. 330.74 Each mL contains: Furosemide 10 mg, Sodium Chloride for isotonicity, Sodium Hydroxide, Water for Injection q.s., and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
},
{
"NDCCode": "69452-310-32",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (69452-310-32) ",
"NDC11Code": "69452-0310-32",
"ProductNDC": "69452-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217478",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230913",
"SamplePackage": "N",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine is a phenothiazine derivative, present in prochlorperazine maleate tablets, USP as the maleate. Its chemical name is 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-10 H-phenothiazine (Z)-2-butenedioate (1:2). Prochlorperazine maleate, USP. Prochlorperazine maleate, USP is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP, has the molecular formula C 20H 24ClN 3S2C 4H 4O 4, and the molecular weight is 606.09 g/mol. Prochlorperazine maleate, USP, is a white or pale-yellow crystalline powder. It is slightly soluble in warm chloroform and practically insoluble in water and alcohol. Each film-coated tablet for oral administration contains prochlorperazine maleate, USP equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each film-coated tablet contains the following inactive ingredients consist of colloidal silicon dioxide, corn starch, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6, FD&C blue no. 2, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "70290-310-32",
"PackageDescription": "946 mL in 1 BOTTLE, UNIT-DOSE (70290-310-32) ",
"NDC11Code": "70290-0310-32",
"ProductNDC": "70290-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Firstep Firstflush",
"NonProprietaryName": "Eyewash",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022305",
"LabelerName": "Encon Safety Products, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "465",
"StrengthUnit": "mL/473mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200427",
"SamplePackage": "N",
"IndicationAndUsage": "For cleansing the eye to help relieve irritation or burning by removing loose foreign material."
},
{
"NDCCode": "75839-310-32",
"PackageDescription": "325 g in 1 BOTTLE (75839-310-32)",
"NDC11Code": "75839-0310-32",
"ProductNDC": "75839-310",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Prednisone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "325",
"StrengthUnit": "g/325g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"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": "59985-315-32",
"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": "59985-323-32",
"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": "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": "0264-1800-32",
"PackageDescription": "64 CONTAINER in 1 CASE (0264-1800-32) > 100 mL in 1 CONTAINER",
"NDC11Code": "00264-1800-32",
"ProductNDC": "0264-1800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19780208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017464",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2022-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19780208",
"SamplePackage": "N",
"IndicationAndUsage": "This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.",
"Description": "Each mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mg; Water for Injection USP qspH adjusted with Hydrochloric Acid NFpH: 5.5 (4.5–7.0)Calculated Osmolarity: 310 mOsmol/literConcentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4. This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use of the container to properly identify the ports. No vapor barrier is necessary."
},
{
"NDCCode": "69716-310-01",
"PackageDescription": "8 mL in 1 TUBE (69716-310-01) ",
"NDC11Code": "69716-0310-01",
"ProductNDC": "69716-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Once Finishing",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NoTS Co.,Ltd",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE",
"StrengthNumber": ".48; .32; .16; .15",
"StrengthUnit": "g/8mL; g/8mL; g/8mL; g/8mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "72000-310-06",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (72000-310-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "72000-0310-06",
"ProductNDC": "72000-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sivextro",
"NonProprietaryName": "Tedizolid Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205435",
"LabelerName": "Nabriva Therapeutics US, Inc.",
"SubstanceName": "TEDIZOLID PHOSPHATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "SIVEXTRO is an oxazolidinone antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.",
"Description": "SIVEXTRO (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases. Tedizolid phosphate has the chemical name [(5R)-(3-{3-Fluoro-4-[6-(2-methyl-2H-tetrazol- 5-yl) pyridin-3-yl]phenyl}-2-oxooxazolidin- 5-yl]methyl hydrogen phosphate. Its empirical formula is C17H16FN6O6P and its molecular weight is 450.32. Its structural formula is. Tedizolid phosphate is a white to yellow solid and is administered orally or by intravenous infusion. The pharmacologically active moiety, tedizolid, is an antibacterial agent of the oxazolidinone class. SIVEXTRO tablets contain 200 mg of tedizolid phosphate, and the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol/macrogol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. SIVEXTRO for injection is a sterile, white to off-white sterile lyophilized powder supplied in a clear glass single-dose vial. Each vial contains 200 mg of tedizolid phosphate and the inactive ingredient, mannitol (105 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment. When reconstituted as directed with 4 mL of Sterile Water for Injection, each mL contains 50 mg of tedizolid phosphate. The pH of the reconstituted solution is 7.4 to 8.1."
},
{
"NDCCode": "72000-310-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72000-310-30) ",
"NDC11Code": "72000-0310-30",
"ProductNDC": "72000-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sivextro",
"NonProprietaryName": "Tedizolid Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205435",
"LabelerName": "Nabriva Therapeutics US, Inc.",
"SubstanceName": "TEDIZOLID PHOSPHATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "SIVEXTRO is an oxazolidinone antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.",
"Description": "SIVEXTRO (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases. Tedizolid phosphate has the chemical name [(5R)-(3-{3-Fluoro-4-[6-(2-methyl-2H-tetrazol- 5-yl) pyridin-3-yl]phenyl}-2-oxooxazolidin- 5-yl]methyl hydrogen phosphate. Its empirical formula is C17H16FN6O6P and its molecular weight is 450.32. Its structural formula is. Tedizolid phosphate is a white to yellow solid and is administered orally or by intravenous infusion. The pharmacologically active moiety, tedizolid, is an antibacterial agent of the oxazolidinone class. SIVEXTRO tablets contain 200 mg of tedizolid phosphate, and the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol/macrogol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. SIVEXTRO for injection is a sterile, white to off-white sterile lyophilized powder supplied in a clear glass single-dose vial. Each vial contains 200 mg of tedizolid phosphate and the inactive ingredient, mannitol (105 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment. When reconstituted as directed with 4 mL of Sterile Water for Injection, each mL contains 50 mg of tedizolid phosphate. The pH of the reconstituted solution is 7.4 to 8.1."
},
{
"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."
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"Description": "Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed."
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema:Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 5-(aminosulfonyl)-4-chloro-2-[(2-furanylmethyl)amino] Benzoic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, freely soluble in acetone, in dimethyl formamide and in solutions of alkali hydroxides. Soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform. The structural formula is as follows:. C 12H 11C1N 2O 5S M.W. 330.74 Each mL contains: Furosemide 10 mg, Sodium Chloride for isotonicity, Sodium Hydroxide, Water for Injection q.s., and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
</NDC>
<NDC>
<NDCCode>69452-310-32</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (69452-310-32) </PackageDescription>
<NDC11Code>69452-0310-32</NDC11Code>
<ProductNDC>69452-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217478</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine is a phenothiazine derivative, present in prochlorperazine maleate tablets, USP as the maleate. Its chemical name is 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-10 H-phenothiazine (Z)-2-butenedioate (1:2). Prochlorperazine maleate, USP. Prochlorperazine maleate, USP is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP, has the molecular formula C 20H 24ClN 3S2C 4H 4O 4, and the molecular weight is 606.09 g/mol. Prochlorperazine maleate, USP, is a white or pale-yellow crystalline powder. It is slightly soluble in warm chloroform and practically insoluble in water and alcohol. Each film-coated tablet for oral administration contains prochlorperazine maleate, USP equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each film-coated tablet contains the following inactive ingredients consist of colloidal silicon dioxide, corn starch, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6, FD&C blue no. 2, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70290-310-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, UNIT-DOSE (70290-310-32) </PackageDescription>
<NDC11Code>70290-0310-32</NDC11Code>
<ProductNDC>70290-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Firstep Firstflush</ProprietaryName>
<NonProprietaryName>Eyewash</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022305</ApplicationNumber>
<LabelerName>Encon Safety Products, Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>465</StrengthNumber>
<StrengthUnit>mL/473mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For cleansing the eye to help relieve irritation or burning by removing loose foreign material.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75839-310-32</NDCCode>
<PackageDescription>325 g in 1 BOTTLE (75839-310-32)</PackageDescription>
<NDC11Code>75839-0310-32</NDC11Code>
<ProductNDC>75839-310</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>g/325g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59985-300-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-300-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0300-32</NDC11Code>
<ProductNDC>59985-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Allergy Mold, Dust And Hay</ProprietaryNameSuffix>
<NonProprietaryName>Bovista Lycoperdon, Secale Cornutum, Ustilago Maydis, Wyethia Helenioides</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CLAVICEPS PURPUREA SCLEROTIUM; LYCOPERDON UTRIFORME FRUITING BODY; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT</SubstanceName>
<StrengthNumber>6; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<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]</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>Mold, dust & hay spritz helpful for relief of allergy symptoms - sneezing, itching, dullness, stuffy head, runny eyes & sinuses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-301-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-301-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0301-32</NDC11Code>
<ProductNDC>59985-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Anti-septic Cuts And Scrapes</ProprietaryNameSuffix>
<NonProprietaryName>Baptisia Tinctoria, Echinacea Purpurea, Nitricum Acidum, Thuja Occidentalis, Calendula Officinalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA WHOLE; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6; 30; 30; 6; 6</StrengthNumber>
<StrengthUnit>[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>Speed healing of cuts, scrapes and pain. Diminishes scars. Contains a natural antiseptic.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-305-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-305-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0305-32</NDC11Code>
<ProductNDC>59985-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Burn Relief</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria, Utrica Urens</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; URTICA URENS WHOLE</SubstanceName>
<StrengthNumber>30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[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>For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!.</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>59985-323-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-323-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0323-32</NDC11Code>
<ProductNDC>59985-323</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Diminish Gluten Reactivity</ProprietaryNameSuffix>
<NonProprietaryName>Anatherum Muricatum, Avena Sativa, Arsenicum Album, Berberis Vulgaris, Dioscorea Villosa, Okoubaka Aubrevillei</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CHRYSOPOGON ZIZANIOIDES ROOT; DIOSCOREA VILLOSA TUBER; OKOUBAKA AUBREVILLEI BARK</SubstanceName>
<StrengthNumber>30; 30; 6; 30; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves the symptoms of abdominal pain, discomfort, gas and bloating following consumption of gluten and grains.</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>0264-1800-32</NDCCode>
<PackageDescription>64 CONTAINER in 1 CASE (0264-1800-32) > 100 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1800-32</NDC11Code>
<ProductNDC>0264-1800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19780208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017464</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.</IndicationAndUsage>
<Description>Each mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mg; Water for Injection USP qspH adjusted with Hydrochloric Acid NFpH: 5.5 (4.5–7.0)Calculated Osmolarity: 310 mOsmol/literConcentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4. This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use of the container to properly identify the ports. No vapor barrier is necessary.</Description>
</NDC>
<NDC>
<NDCCode>69716-310-01</NDCCode>
<PackageDescription>8 mL in 1 TUBE (69716-310-01) </PackageDescription>
<NDC11Code>69716-0310-01</NDC11Code>
<ProductNDC>69716-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Once Finishing</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NoTS Co.,Ltd</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.48; .32; .16; .15</StrengthNumber>
<StrengthUnit>g/8mL; g/8mL; g/8mL; g/8mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72000-310-06</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (72000-310-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72000-0310-06</NDC11Code>
<ProductNDC>72000-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sivextro</ProprietaryName>
<NonProprietaryName>Tedizolid Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205435</ApplicationNumber>
<LabelerName>Nabriva Therapeutics US, Inc.</LabelerName>
<SubstanceName>TEDIZOLID PHOSPHATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SIVEXTRO is an oxazolidinone antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.</IndicationAndUsage>
<Description>SIVEXTRO (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases. Tedizolid phosphate has the chemical name [(5R)-(3-{3-Fluoro-4-[6-(2-methyl-2H-tetrazol- 5-yl) pyridin-3-yl]phenyl}-2-oxooxazolidin- 5-yl]methyl hydrogen phosphate. Its empirical formula is C17H16FN6O6P and its molecular weight is 450.32. Its structural formula is. Tedizolid phosphate is a white to yellow solid and is administered orally or by intravenous infusion. The pharmacologically active moiety, tedizolid, is an antibacterial agent of the oxazolidinone class. SIVEXTRO tablets contain 200 mg of tedizolid phosphate, and the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol/macrogol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. SIVEXTRO for injection is a sterile, white to off-white sterile lyophilized powder supplied in a clear glass single-dose vial. Each vial contains 200 mg of tedizolid phosphate and the inactive ingredient, mannitol (105 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment. When reconstituted as directed with 4 mL of Sterile Water for Injection, each mL contains 50 mg of tedizolid phosphate. The pH of the reconstituted solution is 7.4 to 8.1.</Description>
</NDC>
<NDC>
<NDCCode>72000-310-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72000-310-30) </PackageDescription>
<NDC11Code>72000-0310-30</NDC11Code>
<ProductNDC>72000-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sivextro</ProprietaryName>
<NonProprietaryName>Tedizolid Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205435</ApplicationNumber>
<LabelerName>Nabriva Therapeutics US, Inc.</LabelerName>
<SubstanceName>TEDIZOLID PHOSPHATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SIVEXTRO is an oxazolidinone antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.</IndicationAndUsage>
<Description>SIVEXTRO (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases. Tedizolid phosphate has the chemical name [(5R)-(3-{3-Fluoro-4-[6-(2-methyl-2H-tetrazol- 5-yl) pyridin-3-yl]phenyl}-2-oxooxazolidin- 5-yl]methyl hydrogen phosphate. Its empirical formula is C17H16FN6O6P and its molecular weight is 450.32. Its structural formula is. Tedizolid phosphate is a white to yellow solid and is administered orally or by intravenous infusion. The pharmacologically active moiety, tedizolid, is an antibacterial agent of the oxazolidinone class. SIVEXTRO tablets contain 200 mg of tedizolid phosphate, and the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol/macrogol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. SIVEXTRO for injection is a sterile, white to off-white sterile lyophilized powder supplied in a clear glass single-dose vial. Each vial contains 200 mg of tedizolid phosphate and the inactive ingredient, mannitol (105 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment. When reconstituted as directed with 4 mL of Sterile Water for Injection, each mL contains 50 mg of tedizolid phosphate. The pH of the reconstituted solution is 7.4 to 8.1.</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>
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<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>
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<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>
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<Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
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<IndicationAndUsage>CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.</IndicationAndUsage>
<Description>CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG is a solution for injection to be administered subcutaneously. This preparation contains approximately 165 mg of protein per mL (16.5%), of which not less than 96% is normal human immunoglobulin G. CUTAQUIG contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 3% fragments. The product contains on average 0.206 mg of IgA /mL. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 5.0 and 5.5. The osmolality is 310 - 380 mOsmol/kg. The manufacturing process for CUTAQUIG isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. CUTAQUIG contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percent of total IgG: IgG1 is 70%, IgG2 is 25%, IgG3 is 3% and IgG4 is 2%. CUTAQUIG contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (79 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of CUTAQUIG are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol. The CUTAQUIG manufacturing process shows significant viral reduction in in vitro studies ( Table 6 ). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6 Pathogen Reduction During CUTAQUIG Manufacturing. * Not calculated for global Log 10 Reduction Factor. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV). SBV: Sindbis Virus, model virus for Hepatitis C Virus (HCV). MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19. PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV). n.a.: not applicable.</Description>
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<Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
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<Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
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