{
"NDC": [
{
"NDCCode": "42192-341-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 CAPSULE (42192-341-30) ",
"NDC11Code": "42192-0341-30",
"ProductNDC": "42192-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenaissance",
"NonProprietaryName": "Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And Doconexent",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20110613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE",
"StrengthNumber": "30; 28; 800; 325; 55; 29; 1.25; 25; 160",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110613",
"SamplePackage": "N",
"IndicationAndUsage": "Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.",
"Description": "Prenaissance Capsules are a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaque and imprinted with “341” on one side."
},
{
"NDCCode": "42192-107-01",
"PackageDescription": "30 g in 1 TUBE (42192-107-01)",
"NDC11Code": "42192-0107-01",
"ProductNDC": "42192-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081103",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "2.5; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "42192-108-04",
"PackageDescription": "30 TUBE, WITH APPLICATOR in 1 CARTON (42192-108-04) > 4 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "42192-0108-04",
"ProductNDC": "42192-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acella Hydrocortisone Acetate - Pramoxine Singles",
"NonProprietaryName": "Hydrocortisone Acetate, Pramoxine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101108",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE",
"StrengthNumber": "2.5; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "42192-119-30",
"PackageDescription": "1 KIT in 1 CARTON (42192-119-30) * 4 g in 1 TUBE, WITH APPLICATOR * 6 g in 1 POUCH",
"NDC11Code": "42192-0119-30",
"ProductNDC": "42192-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"NonProprietaryName": "Hydrocortisone Acetate Pramoxine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N"
},
{
"NDCCode": "42192-138-30",
"PackageDescription": "30 BOX in 1 CARTON (42192-138-30) > 3.7 g in 1 BOX",
"NDC11Code": "42192-0138-30",
"ProductNDC": "42192-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 10 Sulfur 5",
"NonProprietaryName": "Sulfacetamide Sodium And Sulfur",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110208",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110208",
"SamplePackage": "N"
},
{
"NDCCode": "42192-320-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42192-320-30) ",
"NDC11Code": "42192-0320-30",
"ProductNDC": "42192-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv-select",
"NonProprietaryName": "Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Dl, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091106",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "2500; 80; 400; 10; 3; 3.4; 20; 20; 1; 12; 300; 6; 120; 27; 150; 30; 15; 2",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20091106",
"SamplePackage": "N"
},
{
"NDCCode": "42192-321-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-321-30) ",
"NDC11Code": "42192-0321-30",
"ProductNDC": "42192-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv-dha",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, Ferrous Fumarate, Magnesium, Doconexent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091102",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; FERROUS FUMARATE; MAGNESIUM; DOCONEXENT",
"StrengthNumber": "85; 200; 10; 25; 1; 12; 140; 27; 45; 300",
"StrengthUnit": "[iU]/1; [iU]/1; [iU]/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091102",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: PNV-DHA is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is cobalt blue in color, opaque and imprinted with “BP 321” on one side and blank on the other. PNV-DHA can also be beneficial in improving the nutritional status of women prior to conception."
},
{
"NDCCode": "42192-323-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-323-30) ",
"NDC11Code": "42192-0323-30",
"ProductNDC": "42192-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv-dha",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Calcium, Ferrous Fumarate, Doconexent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101001",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CALCIUM; FERROUS FUMARATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE; FOLIC ACID; DOCONEXENT",
"StrengthNumber": "28; 160; 27; 400; 30; 25; 1.25; 300",
"StrengthUnit": "mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101001",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "PNV-DHA + Docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "PNV-DHA + Docusate is a prescription prenatal/postnatal multivitamin/multimineral softgel with DHA. Each softgel is red in color and imprinted with “323” on one side."
},
{
"NDCCode": "42192-327-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42192-327-30) ",
"NDC11Code": "42192-0327-30",
"ProductNDC": "42192-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 15",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "LIOTHYRONINE; LEVOTHYROXINE",
"StrengthNumber": "2.25; 9.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)."
},
{
"NDCCode": "42192-328-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42192-328-30) ",
"NDC11Code": "42192-0328-30",
"ProductNDC": "42192-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 120",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "76; 18",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)."
},
{
"NDCCode": "42192-329-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42192-329-30) ",
"NDC11Code": "42192-0329-30",
"ProductNDC": "42192-329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 30",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110114",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "19; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)."
},
{
"NDCCode": "42192-330-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42192-330-30) ",
"NDC11Code": "42192-0330-30",
"ProductNDC": "42192-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 60",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "38; 9",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)."
},
{
"NDCCode": "42192-331-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42192-331-30) ",
"NDC11Code": "42192-0331-30",
"ProductNDC": "42192-331",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Np Thyroid 90",
"NonProprietaryName": "Levothyroxine, Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110203",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "57; 13.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)."
},
{
"NDCCode": "42192-332-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-332-30) ",
"NDC11Code": "42192-0332-30",
"ProductNDC": "42192-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv-omega",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Corbonate, Ferrous Fumarate, Potassium Iodide, Magnesium, Doconexent, Icosapent",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100819",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT",
"StrengthNumber": "85; 200; 10; 25; 1; 12; 250; 140; 28; 150; 45; 300; 40",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100819",
"SamplePackage": "N",
"IndicationAndUsage": "PNV - Omega is a multivitamin/ multimineral dietary supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.",
"Description": "PNV-Omega is a prescription prenatal/postnatal dietary supplement softgel capsule that contains multivitamins and minerals along with essential fatty acids. Each softgel is green in color, opaque and imprinted with “332” on one side."
},
{
"NDCCode": "42192-343-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 CAPSULE (42192-343-30) ",
"NDC11Code": "42192-0343-30",
"ProductNDC": "42192-343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenaissance Plus",
"NonProprietaryName": "Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And Doconexent",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20111007",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "30; 100; 400; 250; 50; 1; 28; 25",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111007",
"SamplePackage": "N",
"IndicationAndUsage": "Prenaissance Plus is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "Prenaissance Plus is a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is purple in color, opaque and imprinted with \"343\" on one side."
},
{
"NDCCode": "42192-350-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (42192-350-30) ",
"NDC11Code": "42192-0350-30",
"ProductNDC": "42192-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv-first",
"NonProprietaryName": ".beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130517",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": ".BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON SUCROSE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE; OMEGA-3 FATTY ACIDS",
"StrengthNumber": "1100; 30; 1000; 20; 1.6; 1.8; 15; 1; 2.5; 12; 29; 150; 20; 25; 2; 200",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130517",
"SamplePackage": "N"
},
{
"NDCCode": "42192-352-60",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (42192-352-60) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "42192-0352-60",
"ProductNDC": "42192-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv-ob-dha",
"NonProprietaryName": ".beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent",
"DosageFormName": "KIT",
"StartMarketingDate": "20130517",
"EndMarketingDate": "20150531",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"Status": "Deprecated",
"LastUpdate": "2015-06-05"
},
{
"NDCCode": "42192-353-60",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (42192-353-60) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "42192-0353-60",
"ProductNDC": "42192-353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Choice Ob Dha",
"NonProprietaryName": ".beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent",
"DosageFormName": "KIT",
"StartMarketingDate": "20130517",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "42192-614-30",
"PackageDescription": "10 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIAL",
"NDC11Code": "42192-0614-30",
"ProductNDC": "42192-614",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040573",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211230",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous Phenytoin Sodium Injection can also be substituted, as short-term use, for oral phenytoin. Parenteral Phenytoin should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.1, 2.3) and Warnings and Precautions (5.1)].",
"Description": "Phenytoin Sodium Injection, USP is a sterile solution of 50 mg phenytoin sodium per milliliter for intravenous or intramuscular administration. The solution is in a vehicle containing 40% propylene glycol and 10% alcohol in water for injection, adjusted to pH 12 with sodium hydroxide. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4- imidazolidinedione represented by the following structural formula. C15H11N2NaO2 MW 274.25."
},
{
"NDCCode": "12546-341-30",
"PackageDescription": "30 LOZENGE in 1 BAG (12546-341-30) ",
"NDC11Code": "12546-0341-30",
"ProductNDC": "12546-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Halls",
"ProprietaryNameSuffix": "Extra Strong Menthol Menthol",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Mondelez Global LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N",
"IndicationAndUsage": "<temporarily relieves occasional minor irritation and pain associated with:>. -sore throat. -sore mouth."
},
{
"NDCCode": "13668-341-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-30) ",
"NDC11Code": "13668-0341-30",
"ProductNDC": "13668-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203370",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131223",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).",
"Description": "Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-341-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-341-30)",
"NDC11Code": "16590-0341-30",
"ProductNDC": "16590-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040301",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Warfarin sodium tablets, USP are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Warfarin Sodium Tablets, USP for oral use also contain. All strengths: Anhydrous lactose, corn starch, and magnesium stearate."
},
{
"NDCCode": "16714-341-01",
"PackageDescription": "30 TABLET in 1 BOTTLE (16714-341-01)",
"NDC11Code": "16714-0341-01",
"ProductNDC": "16714-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091368",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "21695-341-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-341-30)",
"NDC11Code": "21695-0341-30",
"ProductNDC": "21695-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074035",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.",
"Description": "Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "24658-341-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24658-341-30) ",
"NDC11Code": "24658-0341-30",
"ProductNDC": "24658-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075401",
"LabelerName": "PuraCap Laboratories LLC dba Blu Pharmaceuticals",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170701",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2- (dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Its molecular formula is C 22H 26N 2O 4SHCl. Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) contain diltiazem hydrochloride in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem Hydrochloride Extended-release Capsules USP (Once-a-Day Dosage) also contain: black iron oxide, corn starch, ethylcellulose, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose 2910, magnesium stearate, nonoxynol 100, pharmaceutical glaze, polysorbate 80, polyacrylic dispersion, povidone, propylene glycol, sucrose, talc and titanium dioxide. The 120 mg capsules also contain: D&C Red #28, FD&C Blue #1 and FD&C Red #40. The 180 mg capsules also contain: D&C Yellow #10, FD&C Blue #1 and FD&C Yellow #6. The 240 mg capsules also contain: D&C Red #28, FD&C Blue #1 and FD&C Red #40. The 300 mg capsules also contain: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6. The 360 mg capsules also contain: FD&C Blue #1. For oral administration. Meets USP requirements for dissolution test 15."
},
{
"NDCCode": "33342-341-07",
"PackageDescription": "30 TABLET in 1 BOTTLE (33342-341-07) ",
"NDC11Code": "33342-0341-07",
"ProductNDC": "33342-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colchicine",
"NonProprietaryName": "Colchicine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210633",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180823",
"SamplePackage": "N",
"IndicationAndUsage": "Colchicine tablet is an alkaloid indicated for: Prophylaxis and treatment of gout flares in adults (1.1). Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).",
"Description": "Colchicine, USP is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine, USP occurs as a pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as scored, brown colored, capsule-shaped, biconvex, film coated tablets, debossed with \"I\" and \"4\" on either side of breakline, containing 0.6 mg of the of the active ingredient colchicine USP and Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate, coating material. The coating material contains hypromellose, polyethylene glycol 8000, talc, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-341-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42571-341-30) ",
"NDC11Code": "42571-0341-30",
"ProductNDC": "42571-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colchicine",
"NonProprietaryName": "Colchicine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212880",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260218",
"SamplePackage": "N",
"IndicationAndUsage": "Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use. The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.",
"Description": "Colchicine is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine is (S)-N-(5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen 7-yl) acetamide. The structural formula is represented below: Colchicine, USP consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine, USP is soluble in water, freely soluble in alcohol, and slightly soluble in ether. Colchicine capsules are supplied for oral administration. Each capsule contains 0.6 mg colchicine, USP and the following inactive ingredients: lactose monohydrate, pregelatinized starch, sodium starch glycolate, colloidal silicon dioxide, stearic acid, the capsule shell contains gelatin, titanium dioxide, FD & C Blue, FD & C Red."
},
{
"NDCCode": "43353-341-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43353-341-30)",
"NDC11Code": "43353-0341-30",
"ProductNDC": "43353-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810827",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "43598-341-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (43598-341-30) > 30 g in 1 BOTTLE, PUMP",
"NDC11Code": "43598-0341-30",
"ProductNDC": "43598-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clocortolone Pivalate",
"NonProprietaryName": "Clocortolone Pivalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140217",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA017765",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "CLOCORTOLONE PIVALATE",
"StrengthNumber": ".001",
"StrengthUnit": "g/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-10-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "46708-341-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (46708-341-30) ",
"NDC11Code": "46708-0341-30",
"ProductNDC": "46708-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil",
"NonProprietaryName": "Candesartan Cilexetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210302",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "CANDESARTAN CILEXETIL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for:. · Treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). · Treatment of heart failure (NYHA class II-IV); candesartan cilexetil tablets reduces cardiovascular death and heart failure hospitalization (1.2).",
"Description": "Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±) - 1 - Hydroxyethyl 2 - ethoxy - 1 - [ p - ( o - 1 H - tetrazol - 5 ylphenyl) benzyl] - 7 -benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is: Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing 4 mg, 8 mg, or 16 mg of candesartan cilexetil, USP and the following inactive ingredients: lactose monohydrate, corn starch, polyethylene glycol 8000, hydroxypropyl cellulose, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide red is added to the 8-mg and 16-mg tablets as a colorant."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42192-341-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 CAPSULE (42192-341-30) </PackageDescription>
<NDC11Code>42192-0341-30</NDC11Code>
<ProductNDC>42192-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenaissance</ProprietaryName>
<NonProprietaryName>Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 28; 800; 325; 55; 29; 1.25; 25; 160</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.</IndicationAndUsage>
<Description>Prenaissance Capsules are a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaque and imprinted with “341” on one side.</Description>
</NDC>
<NDC>
<NDCCode>42192-107-01</NDCCode>
<PackageDescription>30 g in 1 TUBE (42192-107-01)</PackageDescription>
<NDC11Code>42192-0107-01</NDC11Code>
<ProductNDC>42192-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081103</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>42192-108-04</NDCCode>
<PackageDescription>30 TUBE, WITH APPLICATOR in 1 CARTON (42192-108-04) > 4 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>42192-0108-04</NDC11Code>
<ProductNDC>42192-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acella Hydrocortisone Acetate - Pramoxine Singles</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate, Pramoxine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE</SubstanceName>
<StrengthNumber>2.5; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>42192-119-30</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (42192-119-30) * 4 g in 1 TUBE, WITH APPLICATOR * 6 g in 1 POUCH</PackageDescription>
<NDC11Code>42192-0119-30</NDC11Code>
<ProductNDC>42192-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate Pramoxine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-138-30</NDCCode>
<PackageDescription>30 BOX in 1 CARTON (42192-138-30) > 3.7 g in 1 BOX</PackageDescription>
<NDC11Code>42192-0138-30</NDC11Code>
<ProductNDC>42192-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 10 Sulfur 5</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium And Sulfur</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110208</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-320-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42192-320-30) </PackageDescription>
<NDC11Code>42192-0320-30</NDC11Code>
<ProductNDC>42192-320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv-select</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Dl, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>2500; 80; 400; 10; 3; 3.4; 20; 20; 1; 12; 300; 6; 120; 27; 150; 30; 15; 2</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-321-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-321-30) </PackageDescription>
<NDC11Code>42192-0321-30</NDC11Code>
<ProductNDC>42192-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv-dha</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, Ferrous Fumarate, Magnesium, Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091102</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; FERROUS FUMARATE; MAGNESIUM; DOCONEXENT</SubstanceName>
<StrengthNumber>85; 200; 10; 25; 1; 12; 140; 27; 45; 300</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; [iU]/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: PNV-DHA is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is cobalt blue in color, opaque and imprinted with “BP 321” on one side and blank on the other. PNV-DHA can also be beneficial in improving the nutritional status of women prior to conception.</Description>
</NDC>
<NDC>
<NDCCode>42192-323-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-323-30) </PackageDescription>
<NDC11Code>42192-0323-30</NDC11Code>
<ProductNDC>42192-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv-dha</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Calcium, Ferrous Fumarate, Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101001</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CALCIUM; FERROUS FUMARATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE; FOLIC ACID; DOCONEXENT</SubstanceName>
<StrengthNumber>28; 160; 27; 400; 30; 25; 1.25; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101001</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PNV-DHA + Docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>PNV-DHA + Docusate is a prescription prenatal/postnatal multivitamin/multimineral softgel with DHA. Each softgel is red in color and imprinted with “323” on one side.</Description>
</NDC>
<NDC>
<NDCCode>42192-327-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42192-327-30) </PackageDescription>
<NDC11Code>42192-0327-30</NDC11Code>
<ProductNDC>42192-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 15</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LIOTHYRONINE; LEVOTHYROXINE</SubstanceName>
<StrengthNumber>2.25; 9.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
</NDC>
<NDC>
<NDCCode>42192-328-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42192-328-30) </PackageDescription>
<NDC11Code>42192-0328-30</NDC11Code>
<ProductNDC>42192-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 120</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>76; 18</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
</NDC>
<NDC>
<NDCCode>42192-329-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42192-329-30) </PackageDescription>
<NDC11Code>42192-0329-30</NDC11Code>
<ProductNDC>42192-329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 30</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110114</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>19; 4.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
</NDC>
<NDC>
<NDCCode>42192-330-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42192-330-30) </PackageDescription>
<NDC11Code>42192-0330-30</NDC11Code>
<ProductNDC>42192-330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 60</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>38; 9</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
</NDC>
<NDC>
<NDCCode>42192-331-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42192-331-30) </PackageDescription>
<NDC11Code>42192-0331-30</NDC11Code>
<ProductNDC>42192-331</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Np Thyroid 90</ProprietaryName>
<NonProprietaryName>Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>57; 13.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NP Thyroid ®tablets (thyroid tablets, USP) are indicated:. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>NP Thyroid ®(thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T 4levothyroxine) and triiodothyronine sodium (T 3liothyronine) providing 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose (agglomerated) and mineral oil. Contains no ingredient made from a gluten-containing grain (wheat, barley, rye).</Description>
</NDC>
<NDC>
<NDCCode>42192-332-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-332-30) </PackageDescription>
<NDC11Code>42192-0332-30</NDC11Code>
<ProductNDC>42192-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv-omega</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Corbonate, Ferrous Fumarate, Potassium Iodide, Magnesium, Doconexent, Icosapent</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100819</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT</SubstanceName>
<StrengthNumber>85; 200; 10; 25; 1; 12; 250; 140; 28; 150; 45; 300; 40</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PNV - Omega is a multivitamin/ multimineral dietary supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.</IndicationAndUsage>
<Description>PNV-Omega is a prescription prenatal/postnatal dietary supplement softgel capsule that contains multivitamins and minerals along with essential fatty acids. Each softgel is green in color, opaque and imprinted with “332” on one side.</Description>
</NDC>
<NDC>
<NDCCode>42192-343-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 CAPSULE (42192-343-30) </PackageDescription>
<NDC11Code>42192-0343-30</NDC11Code>
<ProductNDC>42192-343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenaissance Plus</ProprietaryName>
<NonProprietaryName>Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111007</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30; 100; 400; 250; 50; 1; 28; 25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenaissance Plus is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>Prenaissance Plus is a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is purple in color, opaque and imprinted with "343" on one side.</Description>
</NDC>
<NDC>
<NDCCode>42192-350-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (42192-350-30) </PackageDescription>
<NDC11Code>42192-0350-30</NDC11Code>
<ProductNDC>42192-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv-first</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON SUCROSE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE; OMEGA-3 FATTY ACIDS</SubstanceName>
<StrengthNumber>1100; 30; 1000; 20; 1.6; 1.8; 15; 1; 2.5; 12; 29; 150; 20; 25; 2; 200</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42192-352-60</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (42192-352-60) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42192-0352-60</NDC11Code>
<ProductNDC>42192-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv-ob-dha</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130517</StartMarketingDate>
<EndMarketingDate>20150531</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-06-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>42192-353-60</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (42192-353-60) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42192-0353-60</NDC11Code>
<ProductNDC>42192-353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Choice Ob Dha</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130517</StartMarketingDate>
<EndMarketingDate>20150731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-08-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>42192-614-30</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>42192-0614-30</NDC11Code>
<ProductNDC>42192-614</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040573</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous Phenytoin Sodium Injection can also be substituted, as short-term use, for oral phenytoin. Parenteral Phenytoin should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.1, 2.3) and Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Phenytoin Sodium Injection, USP is a sterile solution of 50 mg phenytoin sodium per milliliter for intravenous or intramuscular administration. The solution is in a vehicle containing 40% propylene glycol and 10% alcohol in water for injection, adjusted to pH 12 with sodium hydroxide. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4- imidazolidinedione represented by the following structural formula. C15H11N2NaO2 MW 274.25.</Description>
</NDC>
<NDC>
<NDCCode>12546-341-30</NDCCode>
<PackageDescription>30 LOZENGE in 1 BAG (12546-341-30) </PackageDescription>
<NDC11Code>12546-0341-30</NDC11Code>
<ProductNDC>12546-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Halls</ProprietaryName>
<ProprietaryNameSuffix>Extra Strong Menthol Menthol</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Mondelez Global LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage><temporarily relieves occasional minor irritation and pain associated with:>. -sore throat. -sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-341-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-30) </PackageDescription>
<NDC11Code>13668-0341-30</NDC11Code>
<ProductNDC>13668-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203370</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).</IndicationAndUsage>
<Description>Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-341-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-341-30)</PackageDescription>
<NDC11Code>16590-0341-30</NDC11Code>
<ProductNDC>16590-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040301</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Warfarin sodium tablets, USP are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Warfarin Sodium Tablets, USP for oral use also contain. All strengths: Anhydrous lactose, corn starch, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>16714-341-01</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16714-341-01)</PackageDescription>
<NDC11Code>16714-0341-01</NDC11Code>
<ProductNDC>16714-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091368</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>21695-341-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (21695-341-30)</PackageDescription>
<NDC11Code>21695-0341-30</NDC11Code>
<ProductNDC>21695-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074035</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>24658-341-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24658-341-30) </PackageDescription>
<NDC11Code>24658-0341-30</NDC11Code>
<ProductNDC>24658-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075401</ApplicationNumber>
<LabelerName>PuraCap Laboratories LLC dba Blu Pharmaceuticals</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2- (dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Its molecular formula is C 22H 26N 2O 4SHCl. Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) contain diltiazem hydrochloride in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem Hydrochloride Extended-release Capsules USP (Once-a-Day Dosage) also contain: black iron oxide, corn starch, ethylcellulose, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose 2910, magnesium stearate, nonoxynol 100, pharmaceutical glaze, polysorbate 80, polyacrylic dispersion, povidone, propylene glycol, sucrose, talc and titanium dioxide. The 120 mg capsules also contain: D&C Red #28, FD&C Blue #1 and FD&C Red #40. The 180 mg capsules also contain: D&C Yellow #10, FD&C Blue #1 and FD&C Yellow #6. The 240 mg capsules also contain: D&C Red #28, FD&C Blue #1 and FD&C Red #40. The 300 mg capsules also contain: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6. The 360 mg capsules also contain: FD&C Blue #1. For oral administration. Meets USP requirements for dissolution test 15.</Description>
</NDC>
<NDC>
<NDCCode>33342-341-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33342-341-07) </PackageDescription>
<NDC11Code>33342-0341-07</NDC11Code>
<ProductNDC>33342-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colchicine</ProprietaryName>
<NonProprietaryName>Colchicine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210633</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colchicine tablet is an alkaloid indicated for: Prophylaxis and treatment of gout flares in adults (1.1). Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).</IndicationAndUsage>
<Description>Colchicine, USP is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine, USP occurs as a pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as scored, brown colored, capsule-shaped, biconvex, film coated tablets, debossed with "I" and "4" on either side of breakline, containing 0.6 mg of the of the active ingredient colchicine USP and Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate, coating material. The coating material contains hypromellose, polyethylene glycol 8000, talc, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42571-341-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42571-341-30) </PackageDescription>
<NDC11Code>42571-0341-30</NDC11Code>
<ProductNDC>42571-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colchicine</ProprietaryName>
<NonProprietaryName>Colchicine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212880</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use. The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.</IndicationAndUsage>
<Description>Colchicine is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine is (S)-N-(5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen 7-yl) acetamide. The structural formula is represented below: Colchicine, USP consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine, USP is soluble in water, freely soluble in alcohol, and slightly soluble in ether. Colchicine capsules are supplied for oral administration. Each capsule contains 0.6 mg colchicine, USP and the following inactive ingredients: lactose monohydrate, pregelatinized starch, sodium starch glycolate, colloidal silicon dioxide, stearic acid, the capsule shell contains gelatin, titanium dioxide, FD & C Blue, FD & C Red.</Description>
</NDC>
<NDC>
<NDCCode>43353-341-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43353-341-30)</PackageDescription>
<NDC11Code>43353-0341-30</NDC11Code>
<ProductNDC>43353-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810827</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>43598-341-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (43598-341-30) > 30 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>43598-0341-30</NDC11Code>
<ProductNDC>43598-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clocortolone Pivalate</ProprietaryName>
<NonProprietaryName>Clocortolone Pivalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140217</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017765</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>CLOCORTOLONE PIVALATE</SubstanceName>
<StrengthNumber>.001</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46708-341-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (46708-341-30) </PackageDescription>
<NDC11Code>46708-0341-30</NDC11Code>
<ProductNDC>46708-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210302</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for:. · Treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). · Treatment of heart failure (NYHA class II-IV); candesartan cilexetil tablets reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
<Description>Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±) - 1 - Hydroxyethyl 2 - ethoxy - 1 - [ p - ( o - 1 H - tetrazol - 5 ylphenyl) benzyl] - 7 -benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C33H34N6O6, and its structural formula is: Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing 4 mg, 8 mg, or 16 mg of candesartan cilexetil, USP and the following inactive ingredients: lactose monohydrate, corn starch, polyethylene glycol 8000, hydroxypropyl cellulose, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide red is added to the 8-mg and 16-mg tablets as a colorant.</Description>
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