{
"NDC": [
{
"NDCCode": "71919-803-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-803-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0803-14",
"ProductNDC": "71919-803",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Sleeplessness",
"NonProprietaryName": "Arsenic Trioxide - Arabic Coffee Bean - Lachesis Muta Venom - Passiflora Incarnata Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PASSIFLORA INCARNATA FLOWERING TOP; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231003",
"SamplePackage": "N",
"IndicationAndUsage": "ARSENICUM ALB Vomiting. COFFEA CRUDA Sleeplessness. LACHESIS Sore throat. PASSIFLORA Sleeplessness."
},
{
"NDCCode": "51021-985-14",
"PackageDescription": "12 CARTON in 1 CASE (51021-985-14) > 1 KIT in 1 CARTON * 5.525 g in 1 BOTTLE (51021-802-55) * 5.525 g in 1 BOTTLE (51021-803-55) * 12.47 mL in 1 JAR * 2.48 g in 1 BOTTLE (51021-801-55) * 88 g in 1 TUBE",
"NDC11Code": "51021-0985-14",
"ProductNDC": "51021-985",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketoprofen, Lidocaine Hydrochloride, Ketamine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20130328",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Sircle Laboratories, LLC",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "65162-803-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (65162-803-14) / 14 CAPSULE in 1 BOTTLE",
"NDC11Code": "65162-0803-14",
"ProductNDC": "65162-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203691",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150403",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide capsules are an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1).",
"Description": "Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide, USP is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide."
},
{
"NDCCode": "71919-800-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-800-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0800-14",
"ProductNDC": "71919-800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Colds And Cough",
"NonProprietaryName": "Aconitum Napellus - Arsenic Trioxide - Bryonia Alba Root - Pulsatilla Vulgaris - Strychnos Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "BRYONIA ALBA ROOT; PULSATILLA VULGARIS; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [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], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "ACONITUM NAP Fear. BRYONIA Worse motion. PULSATILLA Weeping. NUX VOM Vomiting. ARSENICUM ALB Vomiting."
},
{
"NDCCode": "71919-801-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-801-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0801-14",
"ProductNDC": "71919-801",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Flu Like Symptoms",
"NonProprietaryName": "Bryonia Alba Root - Gelsemium Sempervirens Root - Toxicodendron Pubescens Leaf - Arsenic Trioxide Strychnos - Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [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], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "BRYONIA Worse motion. GELSEMIUM Lethargy. RHUS TOX Better motion. ARSENICUM ALB Vomiting. NUX VOM Vomiting."
},
{
"NDCCode": "71919-802-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-802-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0802-14",
"ProductNDC": "71919-802",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Sinus Congestion",
"NonProprietaryName": "Goldenseal - Potassium Dichromate - Pulsatilla Vulgaris",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230929",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PULSATILLA VULGARIS; POTASSIUM DICHROMATE; GOLDENSEAL",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230929",
"SamplePackage": "N",
"IndicationAndUsage": "HYDRASTIS Sinuses. KALI BIC Sinuses. PULSATILLA Weeping."
},
{
"NDCCode": "71919-804-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-804-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0804-14",
"ProductNDC": "71919-804",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Headache",
"NonProprietaryName": "Atropa Belladonna - Bryonia Alba Root - Sodium Chloride - Strychnos Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM CHLORIDE; BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED; ATROPA BELLADONNA",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [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], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231003",
"SamplePackage": "N",
"IndicationAndUsage": "BELLADONNA Fever. BRYONIA Worse motion. NAT MUR Sneezing. NUX VOM Vomiting."
},
{
"NDCCode": "71919-805-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-805-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0805-14",
"ProductNDC": "71919-805",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Smoking",
"NonProprietaryName": "Arabica Coffee Bean - Strychnos Nux-vomica Seed - Delphinium Staphisagria Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DELPHINIUM STAPHISAGRIA SEED; STRYCHNOS NUX-VOMICA SEED; ARABICA COFFEE BEAN",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231003",
"SamplePackage": "N",
"IndicationAndUsage": "COFFEA CRUDA Sleeplessness. NUX VOM Vomiting. STAPHYSAG Anger."
},
{
"NDCCode": "71919-806-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-806-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0806-14",
"ProductNDC": "71919-806",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Fungus",
"NonProprietaryName": "Kerosene - Sulfur - Thuja Occidentalis Leafy",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG; KEROSENE; SULFUR",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231003",
"SamplePackage": "N",
"IndicationAndUsage": "PETROLEUM Nausea. SULPHUR Skin problems. THUJA OCC Warts."
},
{
"NDCCode": "71919-807-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-807-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0807-14",
"ProductNDC": "71919-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Hay Fever",
"NonProprietaryName": "Onion - Arsenic Trioxide - Gelsemium Sempervirens Root - Strychnos Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; ONION",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231003",
"SamplePackage": "N",
"IndicationAndUsage": "ALLIUM CEPA Head cold. ARSENICUM ALB Vomiting. GELSEMIUM Lethargy. NUX VOM Vomiting."
},
{
"NDCCode": "71919-808-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-808-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0808-14",
"ProductNDC": "71919-808",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Hot Flashes",
"NonProprietaryName": "Lachesis Muta Venom - Pulsatilla Vulgaris - Sepia Officinalis Juice - Sulfur",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SULFUR; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "6; 6; 6; 12",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231003",
"SamplePackage": "N",
"IndicationAndUsage": "LACHESIS Sore throat. PULSATILLA Weeping. SEPIA Indifference. SULPHUR Agitation."
},
{
"NDCCode": "71919-809-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-809-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0809-14",
"ProductNDC": "71919-809",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Stress",
"NonProprietaryName": "Arsenic Trioxide - Dibasic Potassium Phosphate - Passiflora Incarnata Flowering Top - Delphinium Staphisagria Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231004",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DELPHINIUM STAPHISAGRIA SEED; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA FLOWERING TOP; ARSENIC TRIOXIDE",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231004",
"SamplePackage": "N",
"IndicationAndUsage": "ARSENICUM ALB Vomiting. KALI PHOS Irritability. PASSIFLORA Sleeplessness. STAPHYSAG Anger."
},
{
"NDCCode": "71919-810-14",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-810-14) / 1 PELLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "71919-0810-14",
"ProductNDC": "71919-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Stomach Disorders",
"NonProprietaryName": "Arsenic Trioxide - Ipecac - Strychnos Nux-vomica - Pulsatilla Vulgaris - Sulfur",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231004",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PULSATILLA VULGARIS; IPECAC; STRYCHNOS NUX-VOMICA SEED; SULFUR; ARSENIC TRIOXIDE",
"StrengthNumber": "6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [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], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231004",
"SamplePackage": "N",
"IndicationAndUsage": "ARSENICUM ALB Vomiting. IPECAC Nausea. NUX VOM Vomiting. PULSATILLA Weeping. SULPHUR Skin problems."
},
{
"NDCCode": "71919-823-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71919-823-29) / 300 PELLET in 1 BOTTLE, PLASTIC (71919-823-14) ",
"NDC11Code": "71919-0823-29",
"ProductNDC": "71919-823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Poison Ivy",
"NonProprietaryName": "Toxicodendron Pubescens Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240327",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240327",
"SamplePackage": "N",
"IndicationAndUsage": "Rhus Tox Better motion."
},
{
"NDCCode": "0078-1420-15",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15) ",
"NDC11Code": "00078-1420-15",
"ProductNDC": "0078-1420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanrafia",
"NonProprietaryName": "Atrasentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219208",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ATRASENTAN HYDROCHLORIDE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250402",
"SamplePackage": "N",
"IndicationAndUsage": "VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)]. It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.",
"Description": "VANRAFIA contains atrasentan, an endothelin type A (ETA) receptor antagonist. The chemical name of atrasentan hydrochloride is (2R, 3R, 4S)-4-(1,3-benzodioxol-5-yl)-1-[2-(dibutylamino)-2-oxoethyl]-2-(4-methoxyphenyl)-3-pyrrolidinecarboxylic acid hydrochloride. Atrasentan hydrochloride has a molecular weight of 547.09 g/mol, a molecular formula of C29H38N2O6HCl and the following structural formula. Atrasentan is a slightly hygroscopic white to off-white powder that is slightly soluble in water. VANRAFIA is available as a film-coated tablet for oral administration. Each VANRAFIA tablet contains 0.75 mg atrasentan (equivalent to 0.803 mg of atrasentan hydrochloride) and contains the following excipients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, L-cysteine hydrochloride monohydrate, polyethylene glycol, and silicon dioxide."
},
{
"NDCCode": "10702-803-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-803-01) ",
"NDC11Code": "10702-0803-01",
"ProductNDC": "10702-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hcl",
"NonProprietaryName": "Oxycodone Hcl",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190405",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022272",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190405",
"SamplePackage": "N",
"IndicationAndUsage": "OXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: 1 Adults; and, 2 Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.",
"Description": "OXYCODONE HCl EXTENDED-RELEASE TABLETS are an opioid agonist supplied in 10 mg, 20 mg, and 40 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows. The chemical name is 4, 5a-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The 10 mg, 20 mg, and 40 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide. The 10 mg tablets also contain hydroxypropyl cellulose. The 20 mg tablets also contain polysorbate 80 and red iron oxide. The 40 mg tablets also contain polysorbate 80 and yellow iron oxide."
},
{
"NDCCode": "21130-803-26",
"PackageDescription": "1 TUBE in 1 CARTON (21130-803-26) / 113 g in 1 TUBE",
"NDC11Code": "21130-0803-26",
"ProductNDC": "21130-803",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitamin A D",
"NonProprietaryName": "Lanolin, Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Lucerne North America LLC",
"SubstanceName": "LANOLIN; PETROLATUM",
"StrengthNumber": "133; 459",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20121112",
"SamplePackage": "N",
"IndicationAndUsage": "helps treat and prevent diaper rash. temporarily protects minor:. cuts . scrapes. burns. temporarily protects and helps relieve chafed, chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "23667-803-01",
"PackageDescription": "150 g in 1 CAN (23667-803-01) ",
"NDC11Code": "23667-0803-01",
"ProductNDC": "23667-803",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Goodsense Athletes Foot Antifungal",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170120",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Formulated Solutions, LLC",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170120",
"SamplePackage": "N",
"IndicationAndUsage": "proven clinically effective in the treatment of most athlet's foot (Tinea pedis), Jack itch (tinea cruis) and ringworm (tinea corporis). helps prevent most athlete's foot with daily use. for effective relief if itching, burning, cracking."
},
{
"NDCCode": "24538-803-01",
"PackageDescription": "7 kg in 1 DRUM (24538-803-01) ",
"NDC11Code": "24538-0803-01",
"ProductNDC": "24538-803",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Retatrutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260416",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Shanghai SynTheAll Pharmaceutical Co., Ltd.",
"SubstanceName": "RETATRUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-09-14",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "16-APR-26"
},
{
"NDCCode": "46708-803-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-803-30) ",
"NDC11Code": "46708-0803-30",
"ProductNDC": "46708-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218330",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone extended-release tablet is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2) Efficacy was established in two 6-week trials in adult patients. (14.2).",
"Description": "Paliperidone extended-release tablet contains paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- Paliperidone, USP. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H- pyrido [l,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1 N hydrochloride and in methylene chloride, slightly soluble in N,N dimethyl formamide and in tetrahydrofuran; practically insoluble in water, in 0.1 N sodium hydroxide, and in hexane. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone Extended-Release Tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use. Inactive ingredients are mannitol, microcrystalline cellulose, hypromellose, magnesium stearate, hydroxypropyl cellulose, hypromellose phthalate, ethylcellulose, dibutyl sebacate, polyethylene glycol and titanium dioxide. The 1.5 mg tablets also contain FD&C Yellow #6 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #2 Aluminum Lake. The 6 mg tablets also contain iron oxide yellow, iron oxide red and iron oxide black. The 9 mg tablets also contain iron oxide red. The tablets are imprinted with edible black ink. The edible ink contains shellac, isopropyl alcohol, iron oxide black, n-butyl alcohol, propylene glycol and ammonium hydroxide. Delivery System Components and Performance. Paliperidone Extended-Release Tablet uses a pH-independent hydrophilic matrix and pH dependent enteric coating to deliver Paliperidone, USP at a controlled rate. The Paliperidone Extended-Release Tablet comprises of an inner core made of the drug, rate controlling pH independent hydrophilic polymers and other excipients. The core is surrounded by barrier layer of pH independent polymer followed by enteric coating. When tablet expose to an acidic environment such as the stomach, the drug release will be minimal due to outer enteric coating of the pH dependent polymer. The outer enteric coating upon reaching an environment of pH 5.5 and above it starts to dissolve and the polymer in the inner core tablet will hydrate to form a gel layer. The drug releases via diffusion from a gel layer and subsequently through gel erosion."
},
{
"NDCCode": "50268-803-12",
"PackageDescription": "20 BLISTER PACK in 1 BOX (50268-803-12) / 1 TABLET, COATED in 1 BLISTER PACK (50268-803-11) ",
"NDC11Code": "50268-0803-12",
"ProductNDC": "50268-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206654",
"LabelerName": "AvPAK",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220819",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole tablets are azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .",
"Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.3. Voriconazole drug substance is a white to off-white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (corn), and a coating containing polyvinyl alcohol-part hydrolyzed, lactose monohydrate, titanium dioxide, macrogol/PEG and talc."
},
{
"NDCCode": "61919-803-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61919-803-30) ",
"NDC11Code": "61919-0803-30",
"ProductNDC": "61919-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076410",
"LabelerName": "DIRECT RX",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160128",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem Tartrate Tablets USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem tartrate tablets USP are a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem tartrate, USP is N,N,6-Trimethyl-2-p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate. It has the following structure: Structural formula for zolpidem tartrate. (C19H21N3O)2C4H6O6 M.W. 764.87. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. Each zolpidem tartrate tablet USP includes the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide; the 5 mg tablet also contains iron oxide red."
},
{
"NDCCode": "62332-803-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-803-30) ",
"NDC11Code": "62332-0803-30",
"ProductNDC": "62332-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218330",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone extended-release tablet is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2) Efficacy was established in two 6-week trials in adult patients. (14.2).",
"Description": "Paliperidone extended-release tablet contains paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone, USP. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H- pyrido [l,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N hydrochloride and methylene chloride; practically insoluble in water, 0.1N sodium hydroxide, and hexane; and slightly soluble in N,N-dimethyl formamide and tetrahydrofuran. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use. Inactive ingredients are dibutyl sebacate, ethylcellulose, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide. The 1.5 mg tablets also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. The 6 mg tablets also contain iron oxide black, iron oxide red and iron oxide yellow. The 9 mg tablets also contain iron oxide red. The tablets are imprinted with edible black ink. The edible ink contains iron oxide black and propylene glycol, shellac. Delivery System Components and Performance Paliperidone extended-release tablet uses a pH-independent hydrophilic matrix and pH dependent enteric coating to deliver paliperidone, USP at a controlled rate. The paliperidone extended-release tablet comprises of an inner core made of the drug, rate controlling pH independent hydrophilic polymers and other excipients. The core is surrounded by barrier layer of pH independent polymer followed by enteric coating. When tablet expose to an acidic environment such as the stomach, the drug release will be minimal due to outer enteric coating of the pH dependent polymer. The outer enteric coating upon reaching an environment of pH 5.5 and above it starts to dissolve and the polymer in the inner core tablet will hydrate to form a gel layer. The drug releases via diffusion from a gel layer and subsequently through gel erosion."
},
{
"NDCCode": "63187-803-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (63187-803-20) ",
"NDC11Code": "63187-0803-20",
"ProductNDC": "63187-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065064",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "500; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170102",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, USP, for oral suspension, USP, and chewable tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP; for oral suspension, USP; and chewable tablets, USP are oral antibacterial combinations consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients: 1 Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium., 2 For Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel)., 3 Chewable Tablets – Aspartame, banana flavoring, cherry flavoring, colloidal silicon dioxide, FD&C Red No. 40, magnesium stearate, mannitol, and sodium starch glycolate. [see Warnings and Precautions (5.6)]Each 200-mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassiumEach 400-mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium."
},
{
"NDCCode": "71104-803-01",
"PackageDescription": "1 KIT in 1 KIT (71104-803-01) * 3 mL in 1 VIAL (71104-485-08) * 3 mL in 1 SYRINGE (71104-035-01) ",
"NDC11Code": "71104-0803-01",
"ProductNDC": "71104-803",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Eloctate",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Fc Fusion Protein",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170906",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125487",
"LabelerName": "Bioverativ Therapeutics Inc.",
"Status": "Active",
"LastUpdate": "2023-05-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170906",
"SamplePackage": "N",
"IndicationAndUsage": "ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Perioperative management of bleeding,, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000 3000, 4000, 5000 or 6000 international units (IU). Each vial of ELOCTATE is labeled with the actual content in IU. The powder for injection is reconstituted with 3 mL sterile water for injection (SWFI) supplied in a sterile prefilled syringe. The reconstituted solution should be essentially free of particles. The final product contains the excipients: sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20. ELOCTATE contains no preservatives. B-domain deleted recombinant Factor VIII, Fc fusion protein (BDD-rFVIIIFc) is the active ingredient in ELOCTATE. BDD-rFVIIIFc is a recombinant protein consisting of a B-domain deleted analogue of human Coagulation Factor VIII covalently linked to the human immunoglobulin G1 (IgG1) Fc domain sequence. The Factor VIII portion of the molecule has a 90 kDa heavy chain and an 80 kDa light chain (similar to endogenous Factor VIII), which are linked by 14 (of 908) amino acids from the central B-domain. The FVIII portion has post-translational modifications comparable to endogenous Factor VIII. The Fc domain of the molecule contains the hinge, CH2, and CH3 regions of IgG1. BDD-rFVIIIFc contains 1890 amino acids with an apparent molecular weight of 220 kDa. The majority of the expressed protein is proteolytically processed to a two chain molecule; however, ELOCTATE may also contain up to 39% of a single chain, non-processed form. Both molecules have been shown to have comparable Factor VIII activity. BDD-rFVIIIFc is produced by recombinant DNA technology from a human embryonic kidney (HEK) cell line, which has been extensively characterized. The HEK cell line expresses BDD-rFVIIIFc into a defined, cell culture medium that does not contain any proteins derived from animal or human sources. BDD-rFVIIIFc is purified using a series of chromatography steps, including affinity capture with a recombinant, single chain antibody fragment produced in a yeast expression system. No human or animal derived proteins are used in the purification or formulation processes. The production process also incorporates two dedicated viral clearance steps - a detergent treatment step for inactivation and a 15 nm filtration step for removal of viruses."
},
{
"NDCCode": "71288-803-21",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-20) ",
"NDC11Code": "71288-0803-21",
"ProductNDC": "71288-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212130",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210115",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate Mofetil is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate Mofetil for Injection, USP is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. Mycophenolate Mofetil for Injection, USP is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg; and anhydrous citric acid, 5 mg. Sodium hydroxide and/or hydrochloric acid may have been used in the manufacture of Mycophenolate Mofetil for Injection, USP to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection, USP yields a slightly yellow solution of MMF, 6 mg per mL [see Dosage and Administration (2.6)]."
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"LabelerName": "Meitheal Pharmaceuticals Inc.",
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"IndicationAndUsage": "Mycophenolate Mofetil is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate Mofetil for Injection, USP is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. Mycophenolate Mofetil for Injection, USP is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg; and anhydrous citric acid, 5 mg. Sodium hydroxide and/or hydrochloric acid may have been used in the manufacture of Mycophenolate Mofetil for Injection, USP to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection, USP yields a slightly yellow solution of MMF, 6 mg per mL [see Dosage and Administration (2.6)]."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "BENZONATATE",
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"StrengthUnit": "mg/1",
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"StartMarketingDatePackage": "20240429",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
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"ProductNDC": "76420-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "BENZONATATE",
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"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
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"ProductNDC": "76420-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
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<SamplePackage>N</SamplePackage>
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<NDC11Code>71919-0805-14</NDC11Code>
<ProductNDC>71919-805</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Smoking</ProprietaryName>
<NonProprietaryName>Arabica Coffee Bean - Strychnos Nux-vomica Seed - Delphinium Staphisagria Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231003</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DELPHINIUM STAPHISAGRIA SEED; STRYCHNOS NUX-VOMICA SEED; ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COFFEA CRUDA Sleeplessness. NUX VOM Vomiting. STAPHYSAG Anger.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-806-14</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (71919-806-14) / 1 PELLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>71919-0806-14</NDC11Code>
<ProductNDC>71919-806</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Fungus</ProprietaryName>
<NonProprietaryName>Kerosene - Sulfur - Thuja Occidentalis Leafy</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231003</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG; KEROSENE; SULFUR</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PETROLEUM Nausea. SULPHUR Skin problems. THUJA OCC Warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-807-14</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (71919-807-14) / 1 PELLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>71919-0807-14</NDC11Code>
<ProductNDC>71919-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Hay Fever</ProprietaryName>
<NonProprietaryName>Onion - Arsenic Trioxide - Gelsemium Sempervirens Root - Strychnos Nux-vomica Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231003</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; ONION</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALLIUM CEPA Head cold. ARSENICUM ALB Vomiting. GELSEMIUM Lethargy. NUX VOM Vomiting.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-808-14</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (71919-808-14) / 1 PELLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>71919-0808-14</NDC11Code>
<ProductNDC>71919-808</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Hot Flashes</ProprietaryName>
<NonProprietaryName>Lachesis Muta Venom - Pulsatilla Vulgaris - Sepia Officinalis Juice - Sulfur</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231003</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SULFUR; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>6; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LACHESIS Sore throat. PULSATILLA Weeping. SEPIA Indifference. SULPHUR Agitation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-809-14</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (71919-809-14) / 1 PELLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>71919-0809-14</NDC11Code>
<ProductNDC>71919-809</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Stress</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide - Dibasic Potassium Phosphate - Passiflora Incarnata Flowering Top - Delphinium Staphisagria Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231004</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DELPHINIUM STAPHISAGRIA SEED; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA FLOWERING TOP; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARSENICUM ALB Vomiting. KALI PHOS Irritability. PASSIFLORA Sleeplessness. STAPHYSAG Anger.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-810-14</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (71919-810-14) / 1 PELLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>71919-0810-14</NDC11Code>
<ProductNDC>71919-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Stomach Disorders</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide - Ipecac - Strychnos Nux-vomica - Pulsatilla Vulgaris - Sulfur</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231004</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>PULSATILLA VULGARIS; IPECAC; STRYCHNOS NUX-VOMICA SEED; SULFUR; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [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], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARSENICUM ALB Vomiting. IPECAC Nausea. NUX VOM Vomiting. PULSATILLA Weeping. SULPHUR Skin problems.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-823-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (71919-823-29) / 300 PELLET in 1 BOTTLE, PLASTIC (71919-823-14) </PackageDescription>
<NDC11Code>71919-0823-29</NDC11Code>
<ProductNDC>71919-823</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Poison Ivy</ProprietaryName>
<NonProprietaryName>Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240327</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rhus Tox Better motion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0078-1420-15</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15) </PackageDescription>
<NDC11Code>00078-1420-15</NDC11Code>
<ProductNDC>0078-1420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vanrafia</ProprietaryName>
<NonProprietaryName>Atrasentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219208</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ATRASENTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)]. It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.</IndicationAndUsage>
<Description>VANRAFIA contains atrasentan, an endothelin type A (ETA) receptor antagonist. The chemical name of atrasentan hydrochloride is (2R, 3R, 4S)-4-(1,3-benzodioxol-5-yl)-1-[2-(dibutylamino)-2-oxoethyl]-2-(4-methoxyphenyl)-3-pyrrolidinecarboxylic acid hydrochloride. Atrasentan hydrochloride has a molecular weight of 547.09 g/mol, a molecular formula of C29H38N2O6HCl and the following structural formula. Atrasentan is a slightly hygroscopic white to off-white powder that is slightly soluble in water. VANRAFIA is available as a film-coated tablet for oral administration. Each VANRAFIA tablet contains 0.75 mg atrasentan (equivalent to 0.803 mg of atrasentan hydrochloride) and contains the following excipients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, L-cysteine hydrochloride monohydrate, polyethylene glycol, and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10702-803-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-803-01) </PackageDescription>
<NDC11Code>10702-0803-01</NDC11Code>
<ProductNDC>10702-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hcl</ProprietaryName>
<NonProprietaryName>Oxycodone Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190405</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022272</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: 1 Adults; and, 2 Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.</IndicationAndUsage>
<Description>OXYCODONE HCl EXTENDED-RELEASE TABLETS are an opioid agonist supplied in 10 mg, 20 mg, and 40 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows. The chemical name is 4, 5a-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The 10 mg, 20 mg, and 40 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide. The 10 mg tablets also contain hydroxypropyl cellulose. The 20 mg tablets also contain polysorbate 80 and red iron oxide. The 40 mg tablets also contain polysorbate 80 and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>21130-803-26</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21130-803-26) / 113 g in 1 TUBE</PackageDescription>
<NDC11Code>21130-0803-26</NDC11Code>
<ProductNDC>21130-803</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitamin A D</ProprietaryName>
<NonProprietaryName>Lanolin, Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Lucerne North America LLC</LabelerName>
<SubstanceName>LANOLIN; PETROLATUM</SubstanceName>
<StrengthNumber>133; 459</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps treat and prevent diaper rash. temporarily protects minor:. cuts . scrapes. burns. temporarily protects and helps relieve chafed, chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23667-803-01</NDCCode>
<PackageDescription>150 g in 1 CAN (23667-803-01) </PackageDescription>
<NDC11Code>23667-0803-01</NDC11Code>
<ProductNDC>23667-803</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Goodsense Athletes Foot Antifungal</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Formulated Solutions, LLC</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>proven clinically effective in the treatment of most athlet's foot (Tinea pedis), Jack itch (tinea cruis) and ringworm (tinea corporis). helps prevent most athlete's foot with daily use. for effective relief if itching, burning, cracking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24538-803-01</NDCCode>
<PackageDescription>7 kg in 1 DRUM (24538-803-01) </PackageDescription>
<NDC11Code>24538-0803-01</NDC11Code>
<ProductNDC>24538-803</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Retatrutide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260416</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Shanghai SynTheAll Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>RETATRUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-14</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-APR-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>46708-803-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-803-30) </PackageDescription>
<NDC11Code>46708-0803-30</NDC11Code>
<ProductNDC>46708-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218330</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone extended-release tablet is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2) Efficacy was established in two 6-week trials in adult patients. (14.2).</IndicationAndUsage>
<Description>Paliperidone extended-release tablet contains paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- Paliperidone, USP. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H- pyrido [l,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1 N hydrochloride and in methylene chloride, slightly soluble in N,N dimethyl formamide and in tetrahydrofuran; practically insoluble in water, in 0.1 N sodium hydroxide, and in hexane. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone Extended-Release Tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use. Inactive ingredients are mannitol, microcrystalline cellulose, hypromellose, magnesium stearate, hydroxypropyl cellulose, hypromellose phthalate, ethylcellulose, dibutyl sebacate, polyethylene glycol and titanium dioxide. The 1.5 mg tablets also contain FD&C Yellow #6 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #2 Aluminum Lake. The 6 mg tablets also contain iron oxide yellow, iron oxide red and iron oxide black. The 9 mg tablets also contain iron oxide red. The tablets are imprinted with edible black ink. The edible ink contains shellac, isopropyl alcohol, iron oxide black, n-butyl alcohol, propylene glycol and ammonium hydroxide. Delivery System Components and Performance. Paliperidone Extended-Release Tablet uses a pH-independent hydrophilic matrix and pH dependent enteric coating to deliver Paliperidone, USP at a controlled rate. The Paliperidone Extended-Release Tablet comprises of an inner core made of the drug, rate controlling pH independent hydrophilic polymers and other excipients. The core is surrounded by barrier layer of pH independent polymer followed by enteric coating. When tablet expose to an acidic environment such as the stomach, the drug release will be minimal due to outer enteric coating of the pH dependent polymer. The outer enteric coating upon reaching an environment of pH 5.5 and above it starts to dissolve and the polymer in the inner core tablet will hydrate to form a gel layer. The drug releases via diffusion from a gel layer and subsequently through gel erosion.</Description>
</NDC>
<NDC>
<NDCCode>50268-803-12</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX (50268-803-12) / 1 TABLET, COATED in 1 BLISTER PACK (50268-803-11) </PackageDescription>
<NDC11Code>50268-0803-12</NDC11Code>
<ProductNDC>50268-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206654</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole tablets are azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.3. Voriconazole drug substance is a white to off-white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (corn), and a coating containing polyvinyl alcohol-part hydrolyzed, lactose monohydrate, titanium dioxide, macrogol/PEG and talc.</Description>
</NDC>
<NDC>
<NDCCode>61919-803-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-803-30) </PackageDescription>
<NDC11Code>61919-0803-30</NDC11Code>
<ProductNDC>61919-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambien</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076410</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem Tartrate Tablets USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem tartrate tablets USP are a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem tartrate, USP is N,N,6-Trimethyl-2-p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate. It has the following structure: Structural formula for zolpidem tartrate. (C19H21N3O)2C4H6O6 M.W. 764.87. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. Each zolpidem tartrate tablet USP includes the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide; the 5 mg tablet also contains iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>62332-803-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-803-30) </PackageDescription>
<NDC11Code>62332-0803-30</NDC11Code>
<ProductNDC>62332-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218330</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone extended-release tablet is an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2) Efficacy was established in two 6-week trials in adult patients. (14.2).</IndicationAndUsage>
<Description>Paliperidone extended-release tablet contains paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone, USP. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H- pyrido [l,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N hydrochloride and methylene chloride; practically insoluble in water, 0.1N sodium hydroxide, and hexane; and slightly soluble in N,N-dimethyl formamide and tetrahydrofuran. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use. Inactive ingredients are dibutyl sebacate, ethylcellulose, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide. The 1.5 mg tablets also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. The 6 mg tablets also contain iron oxide black, iron oxide red and iron oxide yellow. The 9 mg tablets also contain iron oxide red. The tablets are imprinted with edible black ink. The edible ink contains iron oxide black and propylene glycol, shellac. Delivery System Components and Performance Paliperidone extended-release tablet uses a pH-independent hydrophilic matrix and pH dependent enteric coating to deliver paliperidone, USP at a controlled rate. The paliperidone extended-release tablet comprises of an inner core made of the drug, rate controlling pH independent hydrophilic polymers and other excipients. The core is surrounded by barrier layer of pH independent polymer followed by enteric coating. When tablet expose to an acidic environment such as the stomach, the drug release will be minimal due to outer enteric coating of the pH dependent polymer. The outer enteric coating upon reaching an environment of pH 5.5 and above it starts to dissolve and the polymer in the inner core tablet will hydrate to form a gel layer. The drug releases via diffusion from a gel layer and subsequently through gel erosion.</Description>
</NDC>
<NDC>
<NDCCode>63187-803-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (63187-803-20) </PackageDescription>
<NDC11Code>63187-0803-20</NDC11Code>
<ProductNDC>63187-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065064</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>500; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, USP, for oral suspension, USP, and chewable tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP; for oral suspension, USP; and chewable tablets, USP are oral antibacterial combinations consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients: 1 Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium., 2 For Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel)., 3 Chewable Tablets – Aspartame, banana flavoring, cherry flavoring, colloidal silicon dioxide, FD&C Red No. 40, magnesium stearate, mannitol, and sodium starch glycolate. [see Warnings and Precautions (5.6)]Each 200-mg chewable tablet and each 5 mL of reconstituted 200 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassiumEach 400-mg chewable tablet and each 5 mL of reconstituted 400 mg/5 mL oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>71104-803-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (71104-803-01) * 3 mL in 1 VIAL (71104-485-08) * 3 mL in 1 SYRINGE (71104-035-01) </PackageDescription>
<NDC11Code>71104-0803-01</NDC11Code>
<ProductNDC>71104-803</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Eloctate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Fc Fusion Protein</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170906</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125487</ApplicationNumber>
<LabelerName>Bioverativ Therapeutics Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Perioperative management of bleeding,, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000 3000, 4000, 5000 or 6000 international units (IU). Each vial of ELOCTATE is labeled with the actual content in IU. The powder for injection is reconstituted with 3 mL sterile water for injection (SWFI) supplied in a sterile prefilled syringe. The reconstituted solution should be essentially free of particles. The final product contains the excipients: sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20. ELOCTATE contains no preservatives. B-domain deleted recombinant Factor VIII, Fc fusion protein (BDD-rFVIIIFc) is the active ingredient in ELOCTATE. BDD-rFVIIIFc is a recombinant protein consisting of a B-domain deleted analogue of human Coagulation Factor VIII covalently linked to the human immunoglobulin G1 (IgG1) Fc domain sequence. The Factor VIII portion of the molecule has a 90 kDa heavy chain and an 80 kDa light chain (similar to endogenous Factor VIII), which are linked by 14 (of 908) amino acids from the central B-domain. The FVIII portion has post-translational modifications comparable to endogenous Factor VIII. The Fc domain of the molecule contains the hinge, CH2, and CH3 regions of IgG1. BDD-rFVIIIFc contains 1890 amino acids with an apparent molecular weight of 220 kDa. The majority of the expressed protein is proteolytically processed to a two chain molecule; however, ELOCTATE may also contain up to 39% of a single chain, non-processed form. Both molecules have been shown to have comparable Factor VIII activity. BDD-rFVIIIFc is produced by recombinant DNA technology from a human embryonic kidney (HEK) cell line, which has been extensively characterized. The HEK cell line expresses BDD-rFVIIIFc into a defined, cell culture medium that does not contain any proteins derived from animal or human sources. BDD-rFVIIIFc is purified using a series of chromatography steps, including affinity capture with a recombinant, single chain antibody fragment produced in a yeast expression system. No human or animal derived proteins are used in the purification or formulation processes. The production process also incorporates two dedicated viral clearance steps - a detergent treatment step for inactivation and a 15 nm filtration step for removal of viruses.</Description>
</NDC>
<NDC>
<NDCCode>71288-803-21</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-20) </PackageDescription>
<NDC11Code>71288-0803-21</NDC11Code>
<ProductNDC>71288-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212130</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate Mofetil is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate Mofetil for Injection, USP is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. Mycophenolate Mofetil for Injection, USP is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg; and anhydrous citric acid, 5 mg. Sodium hydroxide and/or hydrochloric acid may have been used in the manufacture of Mycophenolate Mofetil for Injection, USP to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection, USP yields a slightly yellow solution of MMF, 6 mg per mL [see Dosage and Administration (2.6)].</Description>
</NDC>
<NDC>
<NDCCode>71288-803-92</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-92) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-91) </PackageDescription>
<NDC11Code>71288-0803-92</NDC11Code>
<ProductNDC>71288-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212130</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate Mofetil is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate Mofetil for Injection, USP is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. Mycophenolate Mofetil for Injection, USP is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg; and anhydrous citric acid, 5 mg. Sodium hydroxide and/or hydrochloric acid may have been used in the manufacture of Mycophenolate Mofetil for Injection, USP to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection, USP yields a slightly yellow solution of MMF, 6 mg per mL [see Dosage and Administration (2.6)].</Description>
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<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
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<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
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