RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "64950-173-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-173-09) ",
      "NDC11Code": "64950-0173-09",
      "ProductNDC": "64950-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "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": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-173-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (64950-173-01) ",
      "NDC11Code": "64950-0173-01",
      "ProductNDC": "64950-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "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": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-173-14",
      "PackageDescription": "14 TABLET in 1 BOTTLE (64950-173-14) ",
      "NDC11Code": "64950-0173-14",
      "ProductNDC": "64950-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "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": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-170-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-170-09) ",
      "NDC11Code": "64950-0170-09",
      "ProductNDC": "64950-170",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
      "StrengthNumber": "9.5; 2.25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-171-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-171-09) ",
      "NDC11Code": "64950-0171-09",
      "ProductNDC": "64950-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "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": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-172-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-172-09) ",
      "NDC11Code": "64950-0172-09",
      "ProductNDC": "64950-172",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "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": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-174-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-174-09) ",
      "NDC11Code": "64950-0174-09",
      "ProductNDC": "64950-174",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "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": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-175-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-175-09) ",
      "NDC11Code": "64950-0175-09",
      "ProductNDC": "64950-175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
      "StrengthNumber": "114; 27",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-179-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-179-09) ",
      "NDC11Code": "64950-0179-09",
      "ProductNDC": "64950-179",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
      "StrengthNumber": "28.5; 6.75",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "64950-180-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (64950-180-09) ",
      "NDC11Code": "64950-0180-09",
      "ProductNDC": "64950-180",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Renthyroid",
      "NonProprietaryName": "Levothyroxine And Liothyronine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Genus Lifesciences",
      "SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
      "StrengthNumber": "47.5; 11.25",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250301",
      "SamplePackage": "N",
      "IndicationAndUsage": "RenThyroid (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": "RenThyroid (Thyroid Tablets, USP)RenThyroid (Thyroid Tablets, USP) has not been approved by FDA as a new drug. for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. RenThyroid (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). RenThyroid may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
    },
    {
      "NDCCode": "13537-173-10",
      "PackageDescription": "1 TUBE in 1 BOX (13537-173-10)  > 4.3 g in 1 TUBE (13537-173-09)",
      "NDC11Code": "13537-0173-10",
      "ProductNDC": "13537-173",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cy Better Lips Balm Humectante Para Labios Con Color Fps 18",
      "ProprietaryNameSuffix": "(choco Therapy) - Brown",
      "NonProprietaryName": "Avobenzone, Octisalate, Zinc Oxide, Octinoxate, And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140127",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".0003; .0003; .01; .071; .02",
      "StrengthUnit": "g/g; g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Ayuda a prevenir quemaduras solares."
    },
    {
      "NDCCode": "16571-173-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16571-173-09) ",
      "NDC11Code": "16571-0173-09",
      "ProductNDC": "16571-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eplerenone",
      "NonProprietaryName": "Eplerenone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214663",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "EPLERENONE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eplerenone tablets is an aldosterone antagonist indicated for:  Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1)  The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2).",
      "Description": "Eplerenone tablets contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7, 21-dicarboxylic acid, 9, 11-epoxy-17-hydroxy-3-oxo-, γ -lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C24H30O6 and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below. Eplerenone is a white to off-white powder. It is very slightly soluble in water, with its solubility essentially pH-independent The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0. Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc and opadry yellow (hypromellose, iron oxide   red, iron oxide yellow, macrogol, polysorbate 80, and titanium dioxide)."
    },
    {
      "NDCCode": "49884-173-09",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (49884-173-09) ",
      "NDC11Code": "49884-0173-09",
      "ProductNDC": "49884-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150601",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201087",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "5; 25; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150601",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59735-173-10",
      "PackageDescription": "1 TUBE in 1 CARTON (59735-173-10)  / 30 mL in 1 TUBE (59735-173-09) ",
      "NDC11Code": "59735-0173-10",
      "ProductNDC": "59735-173",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Your Name Mineral Sheertint Broad Spectrum Spf 20",
      "NonProprietaryName": "Your Name Mineral Sheer Tint",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "PML NYC, LLC",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "g/30mL; g/30mL",
      "Status": "Active",
      "LastUpdate": "2026-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
    },
    {
      "NDCCode": "59746-173-09",
      "PackageDescription": "500 TABLET in 1 BOTTLE (59746-173-09) ",
      "NDC11Code": "59746-0173-09",
      "ProductNDC": "59746-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010829",
      "EndMarketingDate": "20260501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040362",
      "LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20010829",
      "EndMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, odorless, crystalline powder.  It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43 The structural formula is represented below. Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow # 6, aluminum lake, HT 15-18%."
    },
    {
      "NDCCode": "64220-173-09",
      "PackageDescription": "50 kg in 1 DRUM (64220-173-09) ",
      "NDC11Code": "64220-0173-09",
      "ProductNDC": "64220-173",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20131108",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-05-05",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "08-NOV-13"
    },
    {
      "NDCCode": "71919-173-09",
      "PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-173-09) ",
      "NDC11Code": "71919-0173-09",
      "ProductNDC": "71919-173",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cedron",
      "NonProprietaryName": "Simaba Cedron Seed",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100415",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "SIMABA CEDRON SEED",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100415",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71921-173-09",
      "PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71921-173-09) ",
      "NDC11Code": "71921-0173-09",
      "ProductNDC": "71921-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203332",
      "LabelerName": "Florida Pharmaceutical Products, LLC",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200320",
      "SamplePackage": "N",
      "IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 anic Disorder (PD) [see Clinical Studies (14.4)].",
      "Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water(0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethylcellulose, hypromellose and sugar spheres. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The 37.5 mg capsules also contain iron oxide black. The 75 mg capsules also contain FD&C red no. 3 and FD&C yellow no. 6. The 150 mg capsules also contain iron oxide red and iron oxide yellow. The 37.5 mg, 75 mg and 150 mg capsules are imprinted with black and grey ink which contains iron black oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide."
    },
    {
      "NDCCode": "83589-173-09",
      "PackageDescription": "100 g in 1 BAG (83589-173-09) ",
      "NDC11Code": "83589-0173-09",
      "ProductNDC": "83589-173",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Zinc Thymulin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260501",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
      "SubstanceName": "NONATHYMULIN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-MAY-26"
    },
    {
      "NDCCode": "64950-206-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (64950-206-03) ",
      "NDC11Code": "64950-0206-03",
      "ProductNDC": "64950-206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
      "NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220810",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA005213",
      "LabelerName": "Genus Lifesciences Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE",
      "StrengthNumber": "5; 1.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220810",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]., 3 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.",
      "Description": "Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone bitartrate and homatropine methylbromide tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, pregelatinized starch and stearic acid. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure."
    },
    {
      "NDCCode": "64950-206-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (64950-206-10) ",
      "NDC11Code": "64950-0206-10",
      "ProductNDC": "64950-206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
      "NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220810",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA005213",
      "LabelerName": "Genus Lifesciences Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE",
      "StrengthNumber": "5; 1.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220810",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]., 3 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.",
      "Description": "Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone bitartrate and homatropine methylbromide tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, pregelatinized starch and stearic acid. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure."
    },
    {
      "NDCCode": "64950-290-16",
      "PackageDescription": "473 mL in 1 BOTTLE (64950-290-16) ",
      "NDC11Code": "64950-0290-16",
      "ProductNDC": "64950-290",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
      "NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040387",
      "LabelerName": "Genus Lifesciences Inc.",
      "SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
      "StrengthNumber": "50; 325; 40",
      "StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
      "Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2026-09-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Butalbital, acetaminophen and caffeine oral solution is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
      "Description": "Butalbital, acetaminophen and caffeine are supplied in liquid form for oral administration. Each 15 mL contains. In addition, this drug product contains the following inactive ingredients: citric acid, ethyl maltol, liquid glucose, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with FD&C yellow #6 as coloring, and natural and artificial flavoring. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula."
    },
    {
      "NDCCode": "64950-345-16",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (64950-345-16) ",
      "NDC11Code": "64950-0345-16",
      "ProductNDC": "64950-345",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Promethazine Hydrochloride And Phenylephrine Hydrochloride",
      "NonProprietaryName": "Promethazine Hydrochloride And Phenylephrine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240715",
      "EndMarketingDate": "20270731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040654",
      "LabelerName": "Genus Lifesciences Inc.",
      "SubstanceName": "PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "6.25; 5",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240715",
      "EndMarketingDatePackage": "20270731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Promethazine hydrochloride and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
      "Description": "Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%. Inactive Ingredients: Apricot peach flavor, ascorbic acid, citric acid, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2- (Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S∙HCl, and the following structural formula. Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m- Hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C9H13NO2∙HCl, and the following structural formula."
    },
    {
      "NDCCode": "64950-371-47",
      "PackageDescription": "473 mL in 1 BOTTLE (64950-371-47) ",
      "NDC11Code": "64950-0371-47",
      "ProductNDC": "64950-371",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
      "NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220810",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA005213",
      "LabelerName": "Genus Lifesciences Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE",
      "StrengthNumber": "5; 1.5",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220810",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]., 3 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.",
      "Description": "Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone bitartrate and homatropine methylbromide tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, pregelatinized starch and stearic acid. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure."
    },
    {
      "NDCCode": "64950-381-14",
      "PackageDescription": "14 VIAL in 1 CARTON (64950-381-14)  / .25 mL in 1 VIAL",
      "NDC11Code": "64950-0381-14",
      "ProductNDC": "64950-381",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin Otic",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20241201",
      "EndMarketingDate": "20281130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217887",
      "LabelerName": "Genus Lifesciences",
      "SubstanceName": "CIPROFLOXACIN",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/.25mL",
      "Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20241201",
      "EndMarketingDatePackage": "20281130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.",
      "Description": "Ciprofloxacin otic solution, 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free solution for otic use. Each single-dose container of ciprofloxacin otic solution, 0.2% delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH. Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3∙HCl∙H2O, and molecular weight is 385.82. The chemical structure of ciprofloxacin hydrochloride is."
    },
    {
      "NDCCode": "64950-390-60",
      "PackageDescription": "60 VIAL, SINGLE-DOSE in 1 CARTON (64950-390-60)  / .2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "64950-0390-60",
      "ProductNDC": "64950-390",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
      "NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20250801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216308",
      "LabelerName": "Genus Lifesciences",
      "SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
      "StrengthNumber": "20; 5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/0.5% (preservative free) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1)].",
      "Description": "Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP (preservative free) is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride USP is described chemically as: (4S, 6S)-4-(Ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulphonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. [α] 25°C (C=1, water) = ~ -17°. 405 nm. Its molecular formula is C10H16N2O4S3∙ HCl and its structural formula is."
    },
    {
      "NDCCode": "10544-173-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (10544-173-30)",
      "NDC11Code": "10544-0173-30",
      "ProductNDC": "10544-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079106",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "2.5; 6.25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
      "Description": "Bisoprolol fumarate and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once–daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[-2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate(2:1)(salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP…..  2.5 mg. Hydrochlorothiazide USP…. 6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 5 mg. Hydrochlorothiazide USP…. 6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 10 mg. Hydrochlorothiazide USP…. 6.25 mg. Inactive ingredients include pregelatinized starch, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, colloidal silicon dioxide, copovidone and titanium dioxide. The 5 mg/6.25 mg tablet also contains red and yellow iron oxide. The 2.5 mg/6.25 mg tablet also contains yellow iron oxide."
    },
    {
      "NDCCode": "14445-173-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (14445-173-90) ",
      "NDC11Code": "14445-0173-90",
      "ProductNDC": "14445-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208113",
      "LabelerName": "Indoco Remedies Limited",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2025-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240517",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water."
    },
    {
      "NDCCode": "16714-173-01",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16714-173-01) ",
      "NDC11Code": "16714-0173-01",
      "ProductNDC": "16714-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210801",
      "EndMarketingDate": "20270831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090548",
      "LabelerName": "NORTHSTAR RX LLC",
      "SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210801",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
      "Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate.  The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
    },
    {
      "NDCCode": "16714-173-02",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16714-173-02) ",
      "NDC11Code": "16714-0173-02",
      "ProductNDC": "16714-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090548",
      "LabelerName": "NORTHSTAR RX LLC",
      "SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
      "Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate.  The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"64950-173-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-173-01","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-173-14","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-170-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-171-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-172-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-174-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-175-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-179-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"64950-180-09","ProprietaryName":"Renthyroid","NonProprietaryName":"Levothyroxine And Liothyronine"},{"NDCCode":"13537-173-10","ProprietaryName":"Cy Better Lips Balm Humectante Para Labios Con Color Fps 18","NonProprietaryName":"Avobenzone, Octisalate, Zinc Oxide, Octinoxate, And Oxybenzone"},{"NDCCode":"16571-173-09","ProprietaryName":"Eplerenone","NonProprietaryName":"Eplerenone"},{"NDCCode":"49884-173-09","ProprietaryName":"Amlodipine, Valsartan, Hydrochlorothiazide","NonProprietaryName":"Amlodipine Besylate Valsartan Hydrochlorothiazide"},{"NDCCode":"59735-173-10","ProprietaryName":"Your Name Mineral Sheertint Broad Spectrum Spf 20","NonProprietaryName":"Your Name Mineral Sheer Tint"},{"NDCCode":"59746-173-09","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"64220-173-09","NonProprietaryName":"Tadalafil"},{"NDCCode":"71919-173-09","ProprietaryName":"Cedron","NonProprietaryName":"Simaba Cedron Seed"},{"NDCCode":"71921-173-09","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"83589-173-09","NonProprietaryName":"Zinc Thymulin"},{"NDCCode":"64950-206-03","ProprietaryName":"Hydrocodone Bitartrate And Homatropine Methylbromide","NonProprietaryName":"Hydrocodone Bitartrate And Homatropine Methylbromide"},{"NDCCode":"64950-206-10","ProprietaryName":"Hydrocodone Bitartrate And Homatropine Methylbromide","NonProprietaryName":"Hydrocodone Bitartrate And Homatropine Methylbromide"},{"NDCCode":"64950-290-16","ProprietaryName":"Butalbital, Acetaminophen And Caffeine","NonProprietaryName":"Butalbital, Acetaminophen, And Caffeine"},{"NDCCode":"64950-345-16","ProprietaryName":"Promethazine Hydrochloride And Phenylephrine Hydrochloride","NonProprietaryName":"Promethazine Hydrochloride And Phenylephrine Hydrochloride"},{"NDCCode":"64950-371-47","ProprietaryName":"Hydrocodone Bitartrate And Homatropine Methylbromide","NonProprietaryName":"Hydrocodone Bitartrate And Homatropine Methylbromide"},{"NDCCode":"64950-381-14","ProprietaryName":"Ciprofloxacin Otic","NonProprietaryName":"Ciprofloxacin"},{"NDCCode":"64950-390-60","ProprietaryName":"Dorzolamide Hydrochloride And Timolol Maleate","NonProprietaryName":"Dorzolamide Hydrochloride And Timolol Maleate"},{"NDCCode":"10544-173-30","ProprietaryName":"Bisoprolol Fumarate And Hydrochlorothiazide","NonProprietaryName":"Bisoprolol Fumarate And Hydrochlorothiazide"},{"NDCCode":"14445-173-90","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"16714-173-01","ProprietaryName":"Atorvastatin Calcium","NonProprietaryName":"Atorvastatin Calcium"},{"NDCCode":"16714-173-02","ProprietaryName":"Atorvastatin Calcium","NonProprietaryName":"Atorvastatin Calcium"}]}
                    

<NDCList><NDC><NDCCode>64950-173-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-173-01</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-173-14</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-170-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-171-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-172-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-174-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-175-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-179-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>64950-180-09</NDCCode><ProprietaryName>Renthyroid</ProprietaryName><NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName></NDC><NDC><NDCCode>13537-173-10</NDCCode><ProprietaryName>Cy Better Lips Balm Humectante Para Labios Con Color Fps 18</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, Zinc Oxide, Octinoxate, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>16571-173-09</NDCCode><ProprietaryName>Eplerenone</ProprietaryName><NonProprietaryName>Eplerenone</NonProprietaryName></NDC><NDC><NDCCode>49884-173-09</NDCCode><ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>59735-173-10</NDCCode><ProprietaryName>Your Name Mineral Sheertint Broad Spectrum Spf 20</ProprietaryName><NonProprietaryName>Your Name Mineral Sheer Tint</NonProprietaryName></NDC><NDC><NDCCode>59746-173-09</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>64220-173-09</NDCCode><NonProprietaryName>Tadalafil</NonProprietaryName></NDC><NDC><NDCCode>71919-173-09</NDCCode><ProprietaryName>Cedron</ProprietaryName><NonProprietaryName>Simaba Cedron Seed</NonProprietaryName></NDC><NDC><NDCCode>71921-173-09</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>83589-173-09</NDCCode><NonProprietaryName>Zinc Thymulin</NonProprietaryName></NDC><NDC><NDCCode>64950-206-03</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName></NDC><NDC><NDCCode>64950-206-10</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName></NDC><NDC><NDCCode>64950-290-16</NDCCode><ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName><NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>64950-345-16</NDCCode><ProprietaryName>Promethazine Hydrochloride And Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Promethazine Hydrochloride And Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>64950-371-47</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName></NDC><NDC><NDCCode>64950-381-14</NDCCode><ProprietaryName>Ciprofloxacin Otic</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>64950-390-60</NDCCode><ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName><NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>10544-173-30</NDCCode><ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>14445-173-90</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>16714-173-01</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>16714-173-02</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC></NDCList>