{
"NDC": [
{
"NDCCode": "82685-202-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-202-01) ",
"NDC11Code": "82685-0202-01",
"ProductNDC": "82685-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076268",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. ( 1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3) .",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl (1→4)- O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 0.250 mg- colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg- colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid."
},
{
"NDCCode": "82685-202-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (82685-202-10) ",
"NDC11Code": "82685-0202-10",
"ProductNDC": "82685-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076268",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. ( 1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3) .",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl (1→4)- O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 0.250 mg- colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg- colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid."
},
{
"NDCCode": "82685-201-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-201-01) ",
"NDC11Code": "82685-0201-01",
"ProductNDC": "82685-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076268",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. ( 1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3) .",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl (1→4)- O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 0.250 mg- colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg- colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid."
},
{
"NDCCode": "82685-341-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-341-01) ",
"NDC11Code": "82685-0341-01",
"ProductNDC": "82685-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-342-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-342-01) ",
"NDC11Code": "82685-0342-01",
"ProductNDC": "82685-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-343-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-343-01) ",
"NDC11Code": "82685-0343-01",
"ProductNDC": "82685-343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-344-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-344-01) ",
"NDC11Code": "82685-0344-01",
"ProductNDC": "82685-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-345-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-345-01) ",
"NDC11Code": "82685-0345-01",
"ProductNDC": "82685-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-346-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-346-01) ",
"NDC11Code": "82685-0346-01",
"ProductNDC": "82685-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-347-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-347-01) ",
"NDC11Code": "82685-0347-01",
"ProductNDC": "82685-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-348-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (82685-348-01) ",
"NDC11Code": "82685-0348-01",
"ProductNDC": "82685-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amerithroid",
"NonProprietaryName": "Thyroid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "THYROID",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Amerithroid® (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": "Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
"NDCCode": "82685-360-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (82685-360-01) / 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "82685-0360-01",
"ProductNDC": "82685-360",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thyquidity",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214047",
"LabelerName": "Oliva Therapeutics, LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "ug/5mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. THYQUIDITY is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with THYQUIDITY may induce hyperthyroidism [seeWarnings and Precautions (5.4)]., 2 THYQUIDITY is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "THYQUIDITY (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland, and is very slightly soluble in water. Levothyroxine (T4) sodium hydrate has an empirical formula of C 15H 10I 4NNaO 4 xH 2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:. THYQUIDITY oral solution is supplied in the following strength: 100 mcg per 5 mL (20 mcg per mL). THYQUIDITY oral solution contains the inactive ingredients citric acid monohydrate, glycerin, methylparaben sodium, sodium hydroxide and purified water."
},
{
"NDCCode": "10357-202-01",
"PackageDescription": "1000 kg in 1 DRUM (10357-202-01)",
"NDC11Code": "10357-0202-01",
"ProductNDC": "10357-202",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aspirin",
"DosageFormName": "CRYSTAL",
"StartMarketingDate": "20120224",
"EndMarketingDate": "20220331",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Novacyl SAS",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "100",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04"
},
{
"NDCCode": "10736-202-01",
"PackageDescription": "368 L in 1 CYLINDER (10736-202-01) ",
"NDC11Code": "10736-0202-01",
"ProductNDC": "10736-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19630101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "MEDICAL-TECHNICAL GASES, INC.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19630101",
"SamplePackage": "N"
},
{
"NDCCode": "10812-202-01",
"PackageDescription": "10 g in 1 TUBE (10812-202-01) ",
"NDC11Code": "10812-0202-01",
"ProductNDC": "10812-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Moistureshine Lip Soother",
"ProprietaryNameSuffix": "Sunscreen Spf20 - Glaze 60",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130611",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 20",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130611",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "10842-202-01",
"PackageDescription": "89 mL in 1 TUBE (10842-202-01) ",
"NDC11Code": "10842-0202-01",
"ProductNDC": "10842-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Doctor Hoys Natural Arnica Boost",
"NonProprietaryName": "Hpus Arnica Montana",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "DOCTOR HOY'S, LLC",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130801",
"SamplePackage": "N"
},
{
"NDCCode": "11489-202-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-202-01) / 50 g in 1 JAR",
"NDC11Code": "11489-0202-01",
"ProductNDC": "11489-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum Spf 25",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240828",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.5; .25; 2.5; 3.75",
"StrengthUnit": "g/50g; g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240830",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m-2 p.m. wear long-sleeved shirts, pants, hats and sunglasses."
},
{
"NDCCode": "11534-202-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (11534-202-01) ",
"NDC11Code": "11534-0202-01",
"ProductNDC": "11534-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070464",
"LabelerName": "Sunrise Pharmaceutical, Inc.",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1, 3-dihydro-1- methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain D&C Yellow No. 10 Aluminum Lake; 10-mg tablets contain FD&C Blue No. 1 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Diazepam 2 mg tablets contain no dye."
},
{
"NDCCode": "12027-202-02",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (12027-202-02) > 4 g in 1 TUBE (12027-202-01)",
"NDC11Code": "12027-0202-02",
"ProductNDC": "12027-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disney Classic Characters Lip Smacker Spf Lip Balm",
"NonProprietaryName": "Padimate O, Oxybenzone, Octinoxate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160311",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Markwins Beauty Products",
"SubstanceName": "PADIMATE O; OCTINOXATE; OXYBENZONE",
"StrengthNumber": "8; 7.5; 6",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "12745-202-01",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (12745-202-01) ",
"NDC11Code": "12745-0202-01",
"ProductNDC": "12745-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19800721",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Medical Chemical Corporation",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "8.57",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19800721",
"SamplePackage": "N",
"IndicationAndUsage": "Usage: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions. In case of deep or puncture wounds consult a physician. Discontinue use and get medical attention if redness, irritation or infection develops."
},
{
"NDCCode": "13733-202-01",
"PackageDescription": "40 g in 1 CARTON (13733-202-01) ",
"NDC11Code": "13733-0202-01",
"ProductNDC": "13733-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha All Around Safe Block Waterproof Sun Milk Spf50 40ml",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Able C&C Co., Ltd.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "3; .8746; 2.76",
"StrengthUnit": "g/40g; g/40g; g/40g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N"
},
{
"NDCCode": "14141-202-01",
"PackageDescription": "10 g in 1 BOTTLE (14141-202-01) ",
"NDC11Code": "14141-0202-01",
"ProductNDC": "14141-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Double Use Compact Spf 15 Gold Deluxe Edition Claire 4",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201112",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "4.9; 6.24; 3",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201112",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "14335-202-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (14335-202-01) / 15 mL in 1 BOTTLE",
"NDC11Code": "14335-0202-01",
"ProductNDC": "14335-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20230811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217036",
"LabelerName": "Hainan Poly Pharm. Co., Ltd.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230811",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. FDA approved dissolution test specification differs from the USP."
},
{
"NDCCode": "16714-202-01",
"PackageDescription": "100 mL in 1 BOTTLE (16714-202-01)",
"NDC11Code": "16714-0202-01",
"ProductNDC": "16714-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefadroxil",
"NonProprietaryName": "Cefadroxil",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20071107",
"EndMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065307",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "CEFADROXIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "16729-202-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16729-202-01) ",
"NDC11Code": "16729-0202-01",
"ProductNDC": "16729-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202557",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161215",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg Note :- Not applicable for divided dosesand 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A - potato starch)."
},
{
"NDCCode": "23155-202-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (23155-202-01) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "23155-0202-01",
"ProductNDC": "23155-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetamiophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207035",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pain due to:. muscular aches. backache. minor pain of arthritis. toothache. premenstrual and menstrual cramps. headache. the common cold. temporarily reduces fever."
},
{
"NDCCode": "24415-202-01",
"PackageDescription": "20000 kg in 1 TANK (24415-202-01) ",
"NDC11Code": "24415-0202-01",
"ProductNDC": "24415-202",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20201225",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Gulbrandsen Technologies Inc",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-31",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "25-DEC-20"
},
{
"NDCCode": "30698-202-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (30698-202-01) ",
"NDC11Code": "30698-0202-01",
"ProductNDC": "30698-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Parlodel",
"NonProprietaryName": "Bromocriptine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017962",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "BROMOCRIPTINE MESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140428",
"SamplePackage": "N",
"IndicationAndUsage": "Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.",
"Description": "Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl) -5′-(2-methylpropyl) -, (5′α) -monomethanesulfonate (salt). The structural formula is. 2½ mg SnapTabs®. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, maleic acid, povidone, starch, and another ingredient. 5 mg Capsules. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide, and another ingredient."
},
{
"NDCCode": "31260-202-01",
"PackageDescription": "25 kg in 1 DRUM (31260-202-01) ",
"NDC11Code": "31260-0202-01",
"ProductNDC": "31260-202",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Gulbrandsen Technologies India Private Limited",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-JAN-06"
},
{
"NDCCode": "31645-202-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (31645-202-02) > 9 g in 1 CONTAINER (31645-202-01) ",
"NDC11Code": "31645-0202-02",
"ProductNDC": "31645-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Wear Talc Free Mineral Face Powder",
"ProprietaryNameSuffix": "Spf 16",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Physicians Formula, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "6; 4.2",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>82685-202-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-202-01) </PackageDescription>
<NDC11Code>82685-0202-01</NDC11Code>
<ProductNDC>82685-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076268</ApplicationNumber>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. ( 1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3) .</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl (1→4)- O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 0.250 mg- colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg- colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>82685-202-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (82685-202-10) </PackageDescription>
<NDC11Code>82685-0202-10</NDC11Code>
<ProductNDC>82685-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076268</ApplicationNumber>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. ( 1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3) .</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl (1→4)- O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 0.250 mg- colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg- colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>82685-201-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-201-01) </PackageDescription>
<NDC11Code>82685-0201-01</NDC11Code>
<ProductNDC>82685-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076268</ApplicationNumber>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. ( 1.1) , 2 Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2) , 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3) .</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl (1→4)- O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 0.250 mg- colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg- colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>82685-341-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-341-01) </PackageDescription>
<NDC11Code>82685-0341-01</NDC11Code>
<ProductNDC>82685-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-342-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-342-01) </PackageDescription>
<NDC11Code>82685-0342-01</NDC11Code>
<ProductNDC>82685-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-343-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-343-01) </PackageDescription>
<NDC11Code>82685-0343-01</NDC11Code>
<ProductNDC>82685-343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-344-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-344-01) </PackageDescription>
<NDC11Code>82685-0344-01</NDC11Code>
<ProductNDC>82685-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-345-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-345-01) </PackageDescription>
<NDC11Code>82685-0345-01</NDC11Code>
<ProductNDC>82685-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-346-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-346-01) </PackageDescription>
<NDC11Code>82685-0346-01</NDC11Code>
<ProductNDC>82685-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-347-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-347-01) </PackageDescription>
<NDC11Code>82685-0347-01</NDC11Code>
<ProductNDC>82685-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-348-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82685-348-01) </PackageDescription>
<NDC11Code>82685-0348-01</NDC11Code>
<ProductNDC>82685-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amerithroid</ProprietaryName>
<NonProprietaryName>Thyroid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>THYROID</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amerithroid® (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>Amerithroid® (Thyroid Tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing approximately 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are acacia, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82685-360-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (82685-360-01) / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>82685-0360-01</NDC11Code>
<ProductNDC>82685-360</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thyquidity</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214047</ApplicationNumber>
<LabelerName>Oliva Therapeutics, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/5mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. THYQUIDITY is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with THYQUIDITY may induce hyperthyroidism [seeWarnings and Precautions (5.4)]., 2 THYQUIDITY is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>THYQUIDITY (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland, and is very slightly soluble in water. Levothyroxine (T4) sodium hydrate has an empirical formula of C 15H 10I 4NNaO 4 xH 2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:. THYQUIDITY oral solution is supplied in the following strength: 100 mcg per 5 mL (20 mcg per mL). THYQUIDITY oral solution contains the inactive ingredients citric acid monohydrate, glycerin, methylparaben sodium, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>10357-202-01</NDCCode>
<PackageDescription>1000 kg in 1 DRUM (10357-202-01)</PackageDescription>
<NDC11Code>10357-0202-01</NDC11Code>
<ProductNDC>10357-202</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>CRYSTAL</DosageFormName>
<StartMarketingDate>20120224</StartMarketingDate>
<EndMarketingDate>20220331</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Novacyl SAS</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>10736-202-01</NDCCode>
<PackageDescription>368 L in 1 CYLINDER (10736-202-01) </PackageDescription>
<NDC11Code>10736-0202-01</NDC11Code>
<ProductNDC>10736-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19630101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>MEDICAL-TECHNICAL GASES, INC.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19630101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10812-202-01</NDCCode>
<PackageDescription>10 g in 1 TUBE (10812-202-01) </PackageDescription>
<NDC11Code>10812-0202-01</NDC11Code>
<ProductNDC>10812-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Moistureshine Lip Soother</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Spf20 - Glaze 60</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130611</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10842-202-01</NDCCode>
<PackageDescription>89 mL in 1 TUBE (10842-202-01) </PackageDescription>
<NDC11Code>10842-0202-01</NDC11Code>
<ProductNDC>10842-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Doctor Hoys Natural Arnica Boost</ProprietaryName>
<NonProprietaryName>Hpus Arnica Montana</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>DOCTOR HOY'S, LLC</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11489-202-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-202-01) / 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0202-01</NDC11Code>
<ProductNDC>11489-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum Spf 25</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240828</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.5; .25; 2.5; 3.75</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m-2 p.m. wear long-sleeved shirts, pants, hats and sunglasses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11534-202-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (11534-202-01) </PackageDescription>
<NDC11Code>11534-0202-01</NDC11Code>
<ProductNDC>11534-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070464</ApplicationNumber>
<LabelerName>Sunrise Pharmaceutical, Inc.</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1, 3-dihydro-1- methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, pregelatinized starch and calcium stearate with the following dyes: 5-mg tablets contain D&C Yellow No. 10 Aluminum Lake; 10-mg tablets contain FD&C Blue No. 1 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Diazepam 2 mg tablets contain no dye.</Description>
</NDC>
<NDC>
<NDCCode>12027-202-02</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (12027-202-02) > 4 g in 1 TUBE (12027-202-01)</PackageDescription>
<NDC11Code>12027-0202-02</NDC11Code>
<ProductNDC>12027-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disney Classic Characters Lip Smacker Spf Lip Balm</ProprietaryName>
<NonProprietaryName>Padimate O, Oxybenzone, Octinoxate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160311</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Markwins Beauty Products</LabelerName>
<SubstanceName>PADIMATE O; OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>8; 7.5; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12745-202-01</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, PLASTIC (12745-202-01) </PackageDescription>
<NDC11Code>12745-0202-01</NDC11Code>
<ProductNDC>12745-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19800721</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Medical Chemical Corporation</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>8.57</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19800721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Usage: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions. In case of deep or puncture wounds consult a physician. Discontinue use and get medical attention if redness, irritation or infection develops.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13733-202-01</NDCCode>
<PackageDescription>40 g in 1 CARTON (13733-202-01) </PackageDescription>
<NDC11Code>13733-0202-01</NDC11Code>
<ProductNDC>13733-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha All Around Safe Block Waterproof Sun Milk Spf50 40ml</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Able C&C Co., Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>3; .8746; 2.76</StrengthNumber>
<StrengthUnit>g/40g; g/40g; g/40g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14141-202-01</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (14141-202-01) </PackageDescription>
<NDC11Code>14141-0202-01</NDC11Code>
<ProductNDC>14141-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Double Use Compact Spf 15 Gold Deluxe Edition Claire 4</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>4.9; 6.24; 3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14335-202-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (14335-202-01) / 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>14335-0202-01</NDC11Code>
<ProductNDC>14335-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217036</ApplicationNumber>
<LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. FDA approved dissolution test specification differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>16714-202-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (16714-202-01)</PackageDescription>
<NDC11Code>16714-0202-01</NDC11Code>
<ProductNDC>16714-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefadroxil</ProprietaryName>
<NonProprietaryName>Cefadroxil</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071107</StartMarketingDate>
<EndMarketingDate>20150501</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065307</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>CEFADROXIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>16729-202-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16729-202-01) </PackageDescription>
<NDC11Code>16729-0202-01</NDC11Code>
<ProductNDC>16729-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202557</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg Note :- Not applicable for divided dosesand 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A - potato starch).</Description>
</NDC>
<NDC>
<NDCCode>23155-202-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (23155-202-01) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>23155-0202-01</NDC11Code>
<ProductNDC>23155-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetamiophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207035</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pain due to:. muscular aches. backache. minor pain of arthritis. toothache. premenstrual and menstrual cramps. headache. the common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24415-202-01</NDCCode>
<PackageDescription>20000 kg in 1 TANK (24415-202-01) </PackageDescription>
<NDC11Code>24415-0202-01</NDC11Code>
<ProductNDC>24415-202</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20201225</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Gulbrandsen Technologies Inc</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-31</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-DEC-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>30698-202-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (30698-202-01) </PackageDescription>
<NDC11Code>30698-0202-01</NDC11Code>
<ProductNDC>30698-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Parlodel</ProprietaryName>
<NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017962</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>BROMOCRIPTINE MESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.</IndicationAndUsage>
<Description>Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl) -5′-(2-methylpropyl) -, (5′α) -monomethanesulfonate (salt). The structural formula is. 2½ mg SnapTabs®. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, maleic acid, povidone, starch, and another ingredient. 5 mg Capsules. Active Ingredient: bromocriptine mesylate, USP. Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide, and another ingredient.</Description>
</NDC>
<NDC>
<NDCCode>31260-202-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (31260-202-01) </PackageDescription>
<NDC11Code>31260-0202-01</NDC11Code>
<ProductNDC>31260-202</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Gulbrandsen Technologies India Private Limited</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-06</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>31645-202-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (31645-202-02) > 9 g in 1 CONTAINER (31645-202-01) </PackageDescription>
<NDC11Code>31645-0202-02</NDC11Code>
<ProductNDC>31645-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Wear Talc Free Mineral Face Powder</ProprietaryName>
<ProprietaryNameSuffix>Spf 16</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Physicians Formula, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6; 4.2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>