{
"NDC": [
{
"NDCCode": "54868-4719-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (54868-4719-0)",
"NDC11Code": "54868-4719-00",
"ProductNDC": "54868-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zetia",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021445",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Monotherapy. ZETIA1, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins). ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with Fenofibrate. ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with mixed hyperlipidemia. The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.",
"Description": "ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF."
},
{
"NDCCode": "54868-4719-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (54868-4719-1)",
"NDC11Code": "54868-4719-01",
"ProductNDC": "54868-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zetia",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021445",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Monotherapy. ZETIA1, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins). ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with Fenofibrate. ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with mixed hyperlipidemia. The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.",
"Description": "ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF."
},
{
"NDCCode": "50090-4719-2",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-4719-2) ",
"NDC11Code": "50090-4719-02",
"ProductNDC": "50090-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191114",
"SamplePackage": "N",
"IndicationAndUsage": "Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated for: 1 Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1), 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)Limitations of Use:- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'- tetraiodothyronine in sodium salt form. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4∙xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylatedhydroxy toluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 6 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "50090-4719-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-4719-3) ",
"NDC11Code": "50090-4719-03",
"ProductNDC": "50090-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191114",
"SamplePackage": "N",
"IndicationAndUsage": "Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated for: 1 Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1), 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)Limitations of Use:- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'- tetraiodothyronine in sodium salt form. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4∙xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylatedhydroxy toluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 6 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "52261-4719-0",
"PackageDescription": "1 TUBE in 1 CARTON (52261-4719-0) / .05 kg in 1 TUBE (52261-4719-1) ",
"NDC11Code": "52261-4719-00",
"ProductNDC": "52261-4719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carpe Antiperspirant Underarm Fresh Powder Scent",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220502",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Cosco International, Inc.",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": ".15",
"StrengthUnit": "kg/kg",
"Status": "Active",
"LastUpdate": "2025-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221130",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces underarm perspiration."
},
{
"NDCCode": "52261-4719-1",
"PackageDescription": ".05 kg in 1 TUBE (52261-4719-1) ",
"NDC11Code": "52261-4719-01",
"ProductNDC": "52261-4719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carpe Antiperspirant Underarm Fresh Powder Scent",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220502",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Cosco International, Inc.",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": ".15",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220502",
"SamplePackage": "N"
},
{
"NDCCode": "53002-4719-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-4719-3) ",
"NDC11Code": "53002-4719-03",
"ProductNDC": "53002-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210394",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "Adults. Sildenafil tablets, USP are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Treatment of PAH in Pediatric Patients (Ages 1-17) information is approved for Viatris Specialty LLC’s Revatio (Sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with this information.",
"Description": "Sildenafil, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets: Sildenafil tablets, USP is formulated as white, film-coated circular, biconvex tablets for oral administration. Each tablet contains sildenafil citrate USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "62206-4719-0",
"PackageDescription": "68 g in 1 CAN (62206-4719-0) ",
"NDC11Code": "62206-4719-00",
"ProductNDC": "62206-4719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Badger Clear Zinc Sunscreen Cream Broad Spectrum Spf 40",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "W.S. Badger Company, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "22.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "63629-4719-1",
"PackageDescription": "60 TABLET in 1 BOTTLE (63629-4719-1)",
"NDC11Code": "63629-4719-01",
"ProductNDC": "63629-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol Hydrochloride",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075563",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-14",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68071-4719-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-4719-3) ",
"NDC11Code": "68071-4719-03",
"ProductNDC": "68071-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020301",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021342",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190121",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are 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 levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives."
},
{
"NDCCode": "68071-4719-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (68071-4719-9) ",
"NDC11Code": "68071-4719-09",
"ProductNDC": "68071-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020301",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021342",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190121",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are 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 levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives."
},
{
"NDCCode": "70518-4719-0",
"PackageDescription": "100 POUCH in 1 BOX (70518-4719-0) / 1 TABLET in 1 POUCH (70518-4719-1) ",
"NDC11Code": "70518-4719-00",
"ProductNDC": "70518-4719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N",
"IndicationAndUsage": "1. Sedative 2. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In sub-hypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP."
},
{
"NDCCode": "54868-0010-0",
"PackageDescription": ".296 mL in 1 BOTTLE, GLASS (54868-0010-0)",
"NDC11Code": "54868-0010-00",
"ProductNDC": "54868-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citrate Of Magnesium",
"NonProprietaryName": "Citrate Of Magnesium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54868-0016-0",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-0016-0) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "54868-0016-00",
"ProductNDC": "54868-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dulcolax",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100519",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "54868-0017-1",
"PackageDescription": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-1)",
"NDC11Code": "54868-0017-01",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0017-2",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-2)",
"NDC11Code": "54868-0017-02",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0017-5",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-5)",
"NDC11Code": "54868-0017-05",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0017-6",
"PackageDescription": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-6)",
"NDC11Code": "54868-0017-06",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0018-1",
"PackageDescription": "40 TABLET in 1 BOTTLE (54868-0018-1)",
"NDC11Code": "54868-0018-01",
"ProductNDC": "54868-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
"NDCCode": "54868-0018-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (54868-0018-3)",
"NDC11Code": "54868-0018-03",
"ProductNDC": "54868-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
"NDCCode": "54868-0018-4",
"PackageDescription": "30 TABLET in 1 BOTTLE (54868-0018-4)",
"NDC11Code": "54868-0018-04",
"ProductNDC": "54868-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
"NDCCode": "54868-0018-5",
"PackageDescription": "15 TABLET in 1 BOTTLE (54868-0018-5)",
"NDC11Code": "54868-0018-05",
"ProductNDC": "54868-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
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{
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
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{
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
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{
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Monotherapy. ZETIA1, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins). ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with Fenofibrate. ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with mixed hyperlipidemia. The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.</IndicationAndUsage>
<Description>ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF.</Description>
</NDC>
<NDC>
<NDCCode>54868-4719-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54868-4719-1)</PackageDescription>
<NDC11Code>54868-4719-01</NDC11Code>
<ProductNDC>54868-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zetia</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021445</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Monotherapy. ZETIA1, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins). ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with Fenofibrate. ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with mixed hyperlipidemia. The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.</IndicationAndUsage>
<Description>ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. ZETIA is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, and sodium lauryl sulfate NF.</Description>
</NDC>
<NDC>
<NDCCode>50090-4719-2</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-4719-2) </PackageDescription>
<NDC11Code>50090-4719-02</NDC11Code>
<ProductNDC>50090-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated for: 1 Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1), 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)Limitations of Use:- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'- tetraiodothyronine in sodium salt form. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4∙xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylatedhydroxy toluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 6 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>50090-4719-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-4719-3) </PackageDescription>
<NDC11Code>50090-4719-03</NDC11Code>
<ProductNDC>50090-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated for: 1 Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1), 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)Limitations of Use:- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'- tetraiodothyronine in sodium salt form. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4∙xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylatedhydroxy toluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 6 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>52261-4719-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52261-4719-0) / .05 kg in 1 TUBE (52261-4719-1) </PackageDescription>
<NDC11Code>52261-4719-00</NDC11Code>
<ProductNDC>52261-4719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carpe Antiperspirant Underarm Fresh Powder Scent</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220502</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Cosco International, Inc.</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52261-4719-1</NDCCode>
<PackageDescription>.05 kg in 1 TUBE (52261-4719-1) </PackageDescription>
<NDC11Code>52261-4719-01</NDC11Code>
<ProductNDC>52261-4719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carpe Antiperspirant Underarm Fresh Powder Scent</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220502</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Cosco International, Inc.</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-4719-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-4719-3) </PackageDescription>
<NDC11Code>53002-4719-03</NDC11Code>
<ProductNDC>53002-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210394</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults. Sildenafil tablets, USP are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Treatment of PAH in Pediatric Patients (Ages 1-17) information is approved for Viatris Specialty LLC’s Revatio (Sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with this information.</IndicationAndUsage>
<Description>Sildenafil, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets: Sildenafil tablets, USP is formulated as white, film-coated circular, biconvex tablets for oral administration. Each tablet contains sildenafil citrate USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62206-4719-0</NDCCode>
<PackageDescription>68 g in 1 CAN (62206-4719-0) </PackageDescription>
<NDC11Code>62206-4719-00</NDC11Code>
<ProductNDC>62206-4719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Badger Clear Zinc Sunscreen Cream Broad Spectrum Spf 40</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>W.S. Badger Company, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>22.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63629-4719-1</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (63629-4719-1)</PackageDescription>
<NDC11Code>63629-4719-01</NDC11Code>
<ProductNDC>63629-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075563</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-14</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-4719-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-4719-3) </PackageDescription>
<NDC11Code>68071-4719-03</NDC11Code>
<ProductNDC>68071-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020301</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are 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 levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives.</Description>
</NDC>
<NDC>
<NDCCode>68071-4719-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68071-4719-9) </PackageDescription>
<NDC11Code>68071-4719-09</NDC11Code>
<ProductNDC>68071-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020301</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are 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 levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives.</Description>
</NDC>
<NDC>
<NDCCode>70518-4719-0</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (70518-4719-0) / 1 TABLET in 1 POUCH (70518-4719-1) </PackageDescription>
<NDC11Code>70518-4719-00</NDC11Code>
<ProductNDC>70518-4719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>16.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Sedative 2. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In sub-hypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP.</Description>
</NDC>
<NDC>
<NDCCode>54868-0010-0</NDCCode>
<PackageDescription>.296 mL in 1 BOTTLE, GLASS (54868-0010-0)</PackageDescription>
<NDC11Code>54868-0010-00</NDC11Code>
<ProductNDC>54868-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citrate Of Magnesium</ProprietaryName>
<NonProprietaryName>Citrate Of Magnesium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0016-0</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (54868-0016-0) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-0016-00</NDC11Code>
<ProductNDC>54868-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dulcolax</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100519</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-0017-1</NDCCode>
<PackageDescription>10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-1)</PackageDescription>
<NDC11Code>54868-0017-01</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0017-2</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-2)</PackageDescription>
<NDC11Code>54868-0017-02</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0017-5</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-5)</PackageDescription>
<NDC11Code>54868-0017-05</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0017-6</NDCCode>
<PackageDescription>180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-6)</PackageDescription>
<NDC11Code>54868-0017-06</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0018-1</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (54868-0018-1)</PackageDescription>
<NDC11Code>54868-0018-01</NDC11Code>
<ProductNDC>54868-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061904</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
</NDC>
<NDC>
<NDCCode>54868-0018-3</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (54868-0018-3)</PackageDescription>
<NDC11Code>54868-0018-03</NDC11Code>
<ProductNDC>54868-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061904</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
</NDC>
<NDC>
<NDCCode>54868-0018-4</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54868-0018-4)</PackageDescription>
<NDC11Code>54868-0018-04</NDC11Code>
<ProductNDC>54868-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061904</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0021-2</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (54868-0021-2)</PackageDescription>
<NDC11Code>54868-0021-02</NDC11Code>
<ProductNDC>54868-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0021-3</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (54868-0021-3)</PackageDescription>
<NDC11Code>54868-0021-03</NDC11Code>
<ProductNDC>54868-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0021-4</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (54868-0021-4)</PackageDescription>
<NDC11Code>54868-0021-04</NDC11Code>
<ProductNDC>54868-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>