{
"NDC": [
{
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"PackageDescription": "90 TABLET in 1 BOTTLE (64950-174-09) ",
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"ProductNDC": "64950-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renthyroid",
"NonProprietaryName": "Levothyroxine And Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"LabelerName": "Genus Lifesciences",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
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"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": "64950-174-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (64950-174-01) ",
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"ProductNDC": "64950-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renthyroid",
"NonProprietaryName": "Levothyroxine And Liothyronine",
"DosageFormName": "TABLET",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Genus Lifesciences",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
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"StrengthUnit": "ug/1; ug/1",
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"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": "64950-174-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (64950-174-14) ",
"NDC11Code": "64950-0174-14",
"ProductNDC": "64950-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renthyroid",
"NonProprietaryName": "Levothyroxine And Liothyronine",
"DosageFormName": "TABLET",
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"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]",
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"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",
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"LabelerName": "Genus Lifesciences",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
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"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
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"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",
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"LabelerName": "Genus Lifesciences",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
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"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
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"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) ",
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"LabelerName": "Genus Lifesciences",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "38; 9",
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"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": "64950-173-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (64950-173-09) ",
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"StartMarketingDate": "20250301",
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"LabelerName": "Genus Lifesciences",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
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"StrengthUnit": "ug/1; ug/1",
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"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) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renthyroid",
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"RouteName": "ORAL",
"StartMarketingDate": "20250301",
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"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",
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"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",
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"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",
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"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",
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"RouteName": "ORAL",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Genus Lifesciences",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
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"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",
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"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": "16571-174-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-174-09) ",
"NDC11Code": "16571-0174-09",
"ProductNDC": "16571-174",
"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": "50",
"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": "49884-174-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (49884-174-09) ",
"NDC11Code": "49884-0174-09",
"ProductNDC": "49884-174",
"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": "10; 12.5; 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": "61734-012-09",
"PackageDescription": "174 mL in 1 BOTTLE, PUMP (61734-012-09) ",
"NDC11Code": "61734-0012-09",
"ProductNDC": "61734-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Rubbing Alcohol 70",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100507",
"EndMarketingDate": "20191031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Delon Laboratories (1990) Ltd.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141004",
"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
"NDCCode": "64220-174-09",
"PackageDescription": "50 kg in 1 DRUM (64220-174-09) ",
"NDC11Code": "64220-0174-09",
"ProductNDC": "64220-174",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Paroxetine Mesylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131108",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "PAROXETINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-08-21",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-AUG-24"
},
{
"NDCCode": "71919-174-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-174-09) ",
"NDC11Code": "71919-0174-09",
"ProductNDC": "71919-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cenchris Contortrix",
"NonProprietaryName": "Agkistrodon Contortrix Venom",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "AGKISTRODON CONTORTRIX VENOM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20101021",
"SamplePackage": "N"
},
{
"NDCCode": "71921-174-09",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71921-174-09) ",
"NDC11Code": "71921-0174-09",
"ProductNDC": "71921-174",
"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": "150",
"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": "83589-174-09",
"PackageDescription": "100 g in 1 BAG (83589-174-09) ",
"NDC11Code": "83589-0174-09",
"ProductNDC": "83589-174",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Selank Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260304",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "SELANK",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "04-MAR-26"
},
{
"NDCCode": "83602-174-09",
"PackageDescription": "9 BAG in 1 BOX (83602-174-09) / 1 PATCH in 1 BAG / 6 g in 1 PATCH",
"NDC11Code": "83602-0174-09",
"ProductNDC": "83602-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foot Pain Relief Gel-patch",
"NonProprietaryName": "Lidocaine And Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260124",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.",
"SubstanceName": "MENTHOL; LIDOCAINE",
"StrengthNumber": ".01; .04",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260814",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, neck, shoulders, elbows."
},
{
"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": "0409-0032-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0032-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-0032-10) ",
"NDC11Code": "00409-0032-01",
"ProductNDC": "0409-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217459",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250929",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as 15 mL single-dose vials. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "0517-2051-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2051-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-2051-01) ",
"NDC11Code": "00517-2051-25",
"ProductNDC": "0517-2051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216274",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "0517-2102-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2102-25) / 15 mL in 1 VIAL, SINGLE-DOSE (0517-2102-01) ",
"NDC11Code": "00517-2102-25",
"ProductNDC": "0517-2102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216274",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "0517-2505-25",
"PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0517-2505-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-2505-01) ",
"NDC11Code": "00517-2505-25",
"ProductNDC": "0517-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216274",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "0527-1946-78",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (0527-1946-78) / 177 mL in 1 BOTTLE, PLASTIC (0527-1946-67) ",
"NDC11Code": "00527-1946-78",
"ProductNDC": "0527-1946",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate Oral Soution",
"NonProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209941",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "MAGNESIUM SULFATE, UNSPECIFIED; POTASSIUM SULFATE; SODIUM SULFATE",
"StrengthNumber": "1.6; 3.13; 17.5",
"StrengthUnit": "g/mL; g/mL; g/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-09-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Kit (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: sodium benzoate, NF, sucralose, USP, malic acid, NF, citric acid anhydrous, USP, artificial blueberry flavor, and purified water, USP. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. Sodium Sulfate, USPThe chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC, purifiedThe chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate, USPThe chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Kit also contains a polypropylene mixing container. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information."
}
]
}
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<NDCList>
<NDC>
<NDCCode>64950-174-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (64950-174-09) </PackageDescription>
<NDC11Code>64950-0174-09</NDC11Code>
<ProductNDC>64950-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renthyroid</ProprietaryName>
<NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Genus Lifesciences</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>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>64950-174-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (64950-174-01) </PackageDescription>
<NDC11Code>64950-0174-01</NDC11Code>
<ProductNDC>64950-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renthyroid</ProprietaryName>
<NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Genus Lifesciences</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>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<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.</IndicationAndUsage>
<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.</Description>
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<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.</IndicationAndUsage>
<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.</Description>
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<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.</IndicationAndUsage>
<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.</Description>
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<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.</IndicationAndUsage>
<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.</Description>
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<StrengthUnit>ug/1; ug/1</StrengthUnit>
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<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.</IndicationAndUsage>
<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.</Description>
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<StrengthUnit>ug/1; ug/1</StrengthUnit>
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<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.</IndicationAndUsage>
<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.</Description>
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<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.</IndicationAndUsage>
<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.</Description>
</NDC>
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<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.</IndicationAndUsage>
<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.</Description>
</NDC>
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<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.</IndicationAndUsage>
<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.</Description>
</NDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214663</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>EPLERENONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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).</IndicationAndUsage>
<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).</Description>
</NDC>
<NDC>
<NDCCode>49884-174-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (49884-174-09) </PackageDescription>
<NDC11Code>49884-0174-09</NDC11Code>
<ProductNDC>49884-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201087</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 12.5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61734-012-09</NDCCode>
<PackageDescription>174 mL in 1 BOTTLE, PUMP (61734-012-09) </PackageDescription>
<NDC11Code>61734-0012-09</NDC11Code>
<ProductNDC>61734-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Rubbing Alcohol 70</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100507</StartMarketingDate>
<EndMarketingDate>20191031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Delon Laboratories (1990) Ltd.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141004</StartMarketingDatePackage>
<EndMarketingDatePackage>20191031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-174-09</NDCCode>
<PackageDescription>50 kg in 1 DRUM (64220-174-09) </PackageDescription>
<NDC11Code>64220-0174-09</NDC11Code>
<ProductNDC>64220-174</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Paroxetine Mesylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131108</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PAROXETINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-21</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71919-174-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-174-09) </PackageDescription>
<NDC11Code>71919-0174-09</NDC11Code>
<ProductNDC>71919-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cenchris Contortrix</ProprietaryName>
<NonProprietaryName>Agkistrodon Contortrix Venom</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101021</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>AGKISTRODON CONTORTRIX VENOM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71921-174-09</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71921-174-09) </PackageDescription>
<NDC11Code>71921-0174-09</NDC11Code>
<ProductNDC>71921-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203332</ApplicationNumber>
<LabelerName>Florida Pharmaceutical Products, LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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)].</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>83589-174-09</NDCCode>
<PackageDescription>100 g in 1 BAG (83589-174-09) </PackageDescription>
<NDC11Code>83589-0174-09</NDC11Code>
<ProductNDC>83589-174</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Selank Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260304</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SELANK</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-MAR-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>83602-174-09</NDCCode>
<PackageDescription>9 BAG in 1 BOX (83602-174-09) / 1 PATCH in 1 BAG / 6 g in 1 PATCH</PackageDescription>
<NDC11Code>83602-0174-09</NDC11Code>
<ProductNDC>83602-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foot Pain Relief Gel-patch</ProprietaryName>
<NonProprietaryName>Lidocaine And Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.</LabelerName>
<SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .04</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, neck, shoulders, elbows.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64950-206-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (64950-206-03) </PackageDescription>
<NDC11Code>64950-0206-03</NDC11Code>
<ProductNDC>64950-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA005213</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE</SubstanceName>
<StrengthNumber>5; 1.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>64950-206-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (64950-206-10) </PackageDescription>
<NDC11Code>64950-0206-10</NDC11Code>
<ProductNDC>64950-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA005213</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE</SubstanceName>
<StrengthNumber>5; 1.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>64950-290-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (64950-290-16) </PackageDescription>
<NDC11Code>64950-0290-16</NDC11Code>
<ProductNDC>64950-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040387</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>64950-345-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (64950-345-16) </PackageDescription>
<NDC11Code>64950-0345-16</NDC11Code>
<ProductNDC>64950-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040654</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>64950-371-47</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (64950-371-47) </PackageDescription>
<NDC11Code>64950-0371-47</NDC11Code>
<ProductNDC>64950-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA005213</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE</SubstanceName>
<StrengthNumber>5; 1.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>64950-381-14</NDCCode>
<PackageDescription>14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL</PackageDescription>
<NDC11Code>64950-0381-14</NDC11Code>
<ProductNDC>64950-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin Otic</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<EndMarketingDate>20281130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217887</ApplicationNumber>
<LabelerName>Genus Lifesciences</LabelerName>
<SubstanceName>CIPROFLOXACIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/.25mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<EndMarketingDatePackage>20281130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>64950-390-60</NDCCode>
<PackageDescription>60 VIAL, SINGLE-DOSE in 1 CARTON (64950-390-60) / .2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>64950-0390-60</NDC11Code>
<ProductNDC>64950-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216308</ApplicationNumber>
<LabelerName>Genus Lifesciences</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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)].</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>0409-0032-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0032-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-0032-10) </PackageDescription>
<NDC11Code>00409-0032-01</NDC11Code>
<ProductNDC>0409-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217459</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as 15 mL single-dose vials. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>0517-2051-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2051-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-2051-01) </PackageDescription>
<NDC11Code>00517-2051-25</NDC11Code>
<ProductNDC>0517-2051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216274</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>0517-2102-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2102-25) / 15 mL in 1 VIAL, SINGLE-DOSE (0517-2102-01) </PackageDescription>
<NDC11Code>00517-2102-25</NDC11Code>
<ProductNDC>0517-2102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216274</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>0517-2505-25</NDCCode>
<PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0517-2505-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-2505-01) </PackageDescription>
<NDC11Code>00517-2505-25</NDC11Code>
<ProductNDC>0517-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216274</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>0527-1946-78</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (0527-1946-78) / 177 mL in 1 BOTTLE, PLASTIC (0527-1946-67) </PackageDescription>
<NDC11Code>00527-1946-78</NDC11Code>
<ProductNDC>0527-1946</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate Oral Soution</ProprietaryName>
<NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209941</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>MAGNESIUM SULFATE, UNSPECIFIED; POTASSIUM SULFATE; SODIUM SULFATE</SubstanceName>
<StrengthNumber>1.6; 3.13; 17.5</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Kit (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: sodium benzoate, NF, sucralose, USP, malic acid, NF, citric acid anhydrous, USP, artificial blueberry flavor, and purified water, USP. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. Sodium Sulfate, USPThe chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC, purifiedThe chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate, USPThe chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Kit also contains a polypropylene mixing container. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</Description>
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