{
"NDC": [
{
"NDCCode": "69452-483-93",
"PackageDescription": "237 mL in 1 BOTTLE (69452-483-93) ",
"NDC11Code": "69452-0483-93",
"ProductNDC": "69452-483",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Povidone-iodine 10%",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251006",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "BIONPHARMA INC.",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251006",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "69452-405-93",
"PackageDescription": "240 mL in 1 BOTTLE (69452-405-93) ",
"NDC11Code": "69452-0405-93",
"ProductNDC": "69452-405",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220100",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/7.5mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260303",
"SamplePackage": "N",
"IndicationAndUsage": "controls symptoms of diarrhea, including Travelers' Diarrhea."
},
{
"NDCCode": "69452-330-20",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69452-330-20) ",
"NDC11Code": "69452-0330-20",
"ProductNDC": "69452-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-330-32",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (69452-330-32) ",
"NDC11Code": "69452-0330-32",
"ProductNDC": "69452-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-331-20",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69452-331-20) ",
"NDC11Code": "69452-0331-20",
"ProductNDC": "69452-331",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-331-32",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (69452-331-32) ",
"NDC11Code": "69452-0331-32",
"ProductNDC": "69452-331",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-332-20",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69452-332-20) ",
"NDC11Code": "69452-0332-20",
"ProductNDC": "69452-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-332-32",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (69452-332-32) ",
"NDC11Code": "69452-0332-32",
"ProductNDC": "69452-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-333-20",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69452-333-20) ",
"NDC11Code": "69452-0333-20",
"ProductNDC": "69452-333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240311",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-333-32",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (69452-333-32) ",
"NDC11Code": "69452-0333-32",
"ProductNDC": "69452-333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075667",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-340-72",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69452-340-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-340-60) ",
"NDC11Code": "69452-0340-72",
"ProductNDC": "69452-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091441",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220411",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2."
},
{
"NDCCode": "69452-341-72",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69452-341-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-341-60) ",
"NDC11Code": "69452-0341-72",
"ProductNDC": "69452-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091441",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220411",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2."
},
{
"NDCCode": "69452-380-55",
"PackageDescription": "118 mL in 1 BOTTLE (69452-380-55) ",
"NDC11Code": "69452-0380-55",
"ProductNDC": "69452-380",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride Oral Solution",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219151",
"LabelerName": "Bionpharma Inc.,",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260226",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride oral solution contains the biguanidine antihyperglycemic agent metformin in the form of monohydrochloride salt. Metformin hydrochloride, USP is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is shown as. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.6 g/mol. The pKa of metformin is 2.8, 11.5 (32 ºC). The pH of a 10% aqueous solution of metformin hydrochloride is 6.89. It is freely soluble in purified water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride. Metformin hydrochloride oral solution contains 500 mg of metformin hydrochloride, USP (the equivalent of 389.93 mg metformin) per 5 mL and the following inactive ingredients: Benzoic acid, hydrochloric acid, potassium bicarbonate, purified water, strawberry flavor, sucralose, and xanthan gum."
},
{
"NDCCode": "69452-380-88",
"PackageDescription": "473 mL in 1 BOTTLE (69452-380-88) ",
"NDC11Code": "69452-0380-88",
"ProductNDC": "69452-380",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride Oral Solution",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219151",
"LabelerName": "Bionpharma Inc.,",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250728",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride oral solution contains the biguanidine antihyperglycemic agent metformin in the form of monohydrochloride salt. Metformin hydrochloride, USP is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is shown as. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.6 g/mol. The pKa of metformin is 2.8, 11.5 (32 ºC). The pH of a 10% aqueous solution of metformin hydrochloride is 6.89. It is freely soluble in purified water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride. Metformin hydrochloride oral solution contains 500 mg of metformin hydrochloride, USP (the equivalent of 389.93 mg metformin) per 5 mL and the following inactive ingredients: Benzoic acid, hydrochloric acid, potassium bicarbonate, purified water, strawberry flavor, sucralose, and xanthan gum."
},
{
"NDCCode": "10237-483-50",
"PackageDescription": "2 POUCH in 1 PACKAGE (10237-483-50) / 25 LOZENGE in 1 POUCH",
"NDC11Code": "10237-0483-50",
"ProductNDC": "10237-483",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zicam Cold Remedy",
"NonProprietaryName": "Zinc Acetate Anhydrous And Zinc Gluconate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ZINC ACETATE ANHYDROUS; ZINC GLUCONATE",
"StrengthNumber": "2; 2",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "reduces duration of the common cold and helps relieve nasal congestion. soothes sore throats and coughs."
},
{
"NDCCode": "13537-483-01",
"PackageDescription": "1 TUBE in 1 BOX (13537-483-01) > 7 g in 1 TUBE",
"NDC11Code": "13537-0483-01",
"ProductNDC": "13537-483",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone Studio Look Polvos Compactos De Alta Cobertura Con Fps 20",
"ProprietaryNameSuffix": "(light 2) - Beige",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150824",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150824",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13668-483-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (13668-483-01) ",
"NDC11Code": "13668-0483-01",
"ProductNDC": "13668-483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065062",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150402",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Upper respiratory tract infections caused by Streptococcus pneumoniae.Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.Infections in women caused by Neisseria gonorrhoeae.Syphilis caused by Treponema pallidum subspecies pallidum.Yaws caused by Treponema pallidum subspecies pertenue.Listeriosis due to Listeria monocytogenes.Anthrax due to Bacillus anthracis.Vincent’s infection caused by Fusobacterium fusiforme.Actinomycosis caused by Actinomyces israelii.Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP 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.",
"Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. Each minocycline hydrochloride capsule, USP for oral administration contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "14141-483-01",
"PackageDescription": "1 TUBE in 1 BOX (14141-483-01) > 7 g in 1 TUBE",
"NDC11Code": "14141-0483-01",
"ProductNDC": "14141-483",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone Studio Look Polvos Compactos De Alta Cobertura Con Fps 20",
"ProprietaryNameSuffix": "(light 2) - Beige",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150824",
"EndMarketingDate": "20240129",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150824",
"EndMarketingDatePackage": "20240129",
"SamplePackage": "N"
},
{
"NDCCode": "16714-483-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE",
"NDC11Code": "16714-0483-01",
"ProductNDC": "16714-483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Palmitate Hydrochloride (pediatric)",
"NonProprietaryName": "Clindamycin Palmitate Hydrochloride (pediatric)",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202409",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130430",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin palmitate hydrochloride for oral solution (Pediatric) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution (Pediatric) and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution (Pediatric) 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.",
"Description": "Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride. Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is white flavored granules containing clindamycin palmitate hydrochloride USP and becomes colorless to off-white with cherry flavored solution after reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, isopropyl alcohol, poloxamer, simethicone emulsion, and sucrose."
},
{
"NDCCode": "16714-483-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "16714-0483-02",
"ProductNDC": "16714-483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Palmitate Hydrochloride (pediatric)",
"NonProprietaryName": "Clindamycin Palmitate Hydrochloride (pediatric)",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202409",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221114",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin palmitate hydrochloride for oral solution (Pediatric) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution (Pediatric) and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution (Pediatric) 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.",
"Description": "Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride. Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is white flavored granules containing clindamycin palmitate hydrochloride USP and becomes colorless to off-white with cherry flavored solution after reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, isopropyl alcohol, poloxamer, simethicone emulsion, and sucrose."
},
{
"NDCCode": "16729-483-03",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (16729-483-03) / 5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "16729-0483-03",
"ProductNDC": "16729-483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212868",
"LabelerName": "Accord Healthcare, Inc.,",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210819",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.",
"Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 4.0. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na +) and chloride (Cl -) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17H 23NO 3) 2H 2SO 4H 2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water."
},
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"RouteName": "INTRAVENOUS",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212868",
"LabelerName": "Accord Healthcare, Inc.,",
"SubstanceName": "ATROPINE SULFATE",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
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"IndicationAndUsage": "Atropine Sulfate Injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.",
"Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 4.0. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na +) and chloride (Cl -) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17H 23NO 3) 2H 2SO 4H 2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water."
},
{
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"PackageDescription": "25 kg in 1 DRUM (17205-483-00) ",
"NDC11Code": "17205-0483-00",
"ProductNDC": "17205-483",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121212",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Siegfried AG",
"SubstanceName": "NICOTINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-10-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JAN-13"
},
{
"NDCCode": "21130-483-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (21130-483-10) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "21130-0483-10",
"ProductNDC": "21130-483",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Day Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209094",
"LabelerName": "Safeway, Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N"
},
{
"NDCCode": "21195-483-50",
"PackageDescription": "820.5 kg in 1 PACKAGE (21195-483-50)",
"NDC11Code": "21195-0483-50",
"ProductNDC": "21195-483",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140506",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Kurita Water Industries (Jiangyin) Co., Ltd.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "21195-483-51",
"PackageDescription": "729.75 kg in 1 DRUM (21195-483-51)",
"NDC11Code": "21195-0483-51",
"ProductNDC": "21195-483",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140506",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Kurita Water Industries (Jiangyin) Co., Ltd.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "21195-483-66",
"PackageDescription": "130.5 kg in 1 PACKAGE (21195-483-66)",
"NDC11Code": "21195-0483-66",
"ProductNDC": "21195-483",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140506",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Kurita Water Industries (Jiangyin) Co., Ltd.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "21695-483-30",
"PackageDescription": "30 g in 1 TUBE (21695-483-30)",
"NDC11Code": "21695-0483-30",
"ProductNDC": "21695-483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074407",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of propylene glycol, carbomer 934P, sodium hydroxide and purified water. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate, PEG 100 stearate, white wax, chlorocresol, sodium citrate anhydrous, citric acid anhydrous, and purified water. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "23155-483-31",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (23155-483-31) > 5 mL in 1 VIAL, GLASS",
"NDC11Code": "23155-0483-31",
"ProductNDC": "23155-483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine Hydrochloride",
"NonProprietaryName": "Gemcitabine Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202063",
"LabelerName": "Heritage Pharmaceuticals Inc.",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "25113-333-16",
"PackageDescription": "483 g in 1 BOTTLE (25113-333-16)",
"NDC11Code": "25113-0333-16",
"ProductNDC": "25113-333",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germasidol",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140429",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "The Dodge Company Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".0057",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Antiseptic handwash for handwashing to decrease baceria on the skin."
}
]
}
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<IndicationAndUsage>first aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
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<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<LabelerName>Bionpharma Inc.</LabelerName>
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<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<LabelerName>Bionpharma Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine,1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride, USP is a white to pale yellow crystalline powder, slightly soluble in water pH 1.3 (HCl), water pH 12.6 (NaOH), ethanol 95% and chloroform, sparingly soluble in water pH 6, soluble in methanol, and practically insoluble in n-hexane. Its molecular formula is C 19H 25N 5O 4HCl2H 2O and has a molecular weight of 459.93 g/mole. Each capsule, for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. In addition, each capsule contains the following inactive ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell contains D&C yellow no. 10 (2 mg, 5 mg and 10 mg), D&C red no. 28 (5 mg), FD& C green no. 3 (10 mg), FD&C red no. 40 (5 mg), gelatin, iron oxide black (1 mg), sodium lauryl sulfate, and titanium dioxide. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>69452-340-72</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69452-340-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-340-60) </PackageDescription>
<NDC11Code>69452-0340-72</NDC11Code>
<ProductNDC>69452-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091441</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2.</Description>
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<NDC>
<NDCCode>69452-341-72</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69452-341-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-341-60) </PackageDescription>
<NDC11Code>69452-0341-72</NDC11Code>
<ProductNDC>69452-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091441</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17H25N3O2SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water. Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2.</Description>
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<NDC>
<NDCCode>69452-380-55</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (69452-380-55) </PackageDescription>
<NDC11Code>69452-0380-55</NDC11Code>
<ProductNDC>69452-380</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride Oral Solution</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219151</ApplicationNumber>
<LabelerName>Bionpharma Inc.,</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride oral solution contains the biguanidine antihyperglycemic agent metformin in the form of monohydrochloride salt. Metformin hydrochloride, USP is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is shown as. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.6 g/mol. The pKa of metformin is 2.8, 11.5 (32 ºC). The pH of a 10% aqueous solution of metformin hydrochloride is 6.89. It is freely soluble in purified water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride. Metformin hydrochloride oral solution contains 500 mg of metformin hydrochloride, USP (the equivalent of 389.93 mg metformin) per 5 mL and the following inactive ingredients: Benzoic acid, hydrochloric acid, potassium bicarbonate, purified water, strawberry flavor, sucralose, and xanthan gum.</Description>
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<NDC11Code>69452-0380-88</NDC11Code>
<ProductNDC>69452-380</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride Oral Solution</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219151</ApplicationNumber>
<LabelerName>Bionpharma Inc.,</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride oral solution contains the biguanidine antihyperglycemic agent metformin in the form of monohydrochloride salt. Metformin hydrochloride, USP is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is shown as. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.6 g/mol. The pKa of metformin is 2.8, 11.5 (32 ºC). The pH of a 10% aqueous solution of metformin hydrochloride is 6.89. It is freely soluble in purified water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride. Metformin hydrochloride oral solution contains 500 mg of metformin hydrochloride, USP (the equivalent of 389.93 mg metformin) per 5 mL and the following inactive ingredients: Benzoic acid, hydrochloric acid, potassium bicarbonate, purified water, strawberry flavor, sucralose, and xanthan gum.</Description>
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<NDC>
<NDCCode>10237-483-50</NDCCode>
<PackageDescription>2 POUCH in 1 PACKAGE (10237-483-50) / 25 LOZENGE in 1 POUCH</PackageDescription>
<NDC11Code>10237-0483-50</NDC11Code>
<ProductNDC>10237-483</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zicam Cold Remedy</ProprietaryName>
<NonProprietaryName>Zinc Acetate Anhydrous And Zinc Gluconate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ZINC ACETATE ANHYDROUS; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2; 2</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces duration of the common cold and helps relieve nasal congestion. soothes sore throats and coughs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-483-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-483-01) > 7 g in 1 TUBE</PackageDescription>
<NDC11Code>13537-0483-01</NDC11Code>
<ProductNDC>13537-483</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone Studio Look Polvos Compactos De Alta Cobertura Con Fps 20</ProprietaryName>
<ProprietaryNameSuffix>(light 2) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150824</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-483-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (13668-483-01) </PackageDescription>
<NDC11Code>13668-0483-01</NDC11Code>
<ProductNDC>13668-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065062</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Klebsiella aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Upper respiratory tract infections caused by Streptococcus pneumoniae.Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.Infections in women caused by Neisseria gonorrhoeae.Syphilis caused by Treponema pallidum subspecies pallidum.Yaws caused by Treponema pallidum subspecies pertenue.Listeriosis due to Listeria monocytogenes.Anthrax due to Bacillus anthracis.Vincent’s infection caused by Fusobacterium fusiforme.Actinomycosis caused by Actinomyces israelii.Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP 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.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. Each minocycline hydrochloride capsule, USP for oral administration contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>14141-483-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14141-483-01) > 7 g in 1 TUBE</PackageDescription>
<NDC11Code>14141-0483-01</NDC11Code>
<ProductNDC>14141-483</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone Studio Look Polvos Compactos De Alta Cobertura Con Fps 20</ProprietaryName>
<ProprietaryNameSuffix>(light 2) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150824</StartMarketingDate>
<EndMarketingDate>20240129</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150824</StartMarketingDatePackage>
<EndMarketingDatePackage>20240129</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-483-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>16714-0483-01</NDC11Code>
<ProductNDC>16714-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Palmitate Hydrochloride (pediatric)</ProprietaryName>
<NonProprietaryName>Clindamycin Palmitate Hydrochloride (pediatric)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202409</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PALMITATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin palmitate hydrochloride for oral solution (Pediatric) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution (Pediatric) and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution (Pediatric) 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.</IndicationAndUsage>
<Description>Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride. Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is white flavored granules containing clindamycin palmitate hydrochloride USP and becomes colorless to off-white with cherry flavored solution after reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, isopropyl alcohol, poloxamer, simethicone emulsion, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>16714-483-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>16714-0483-02</NDC11Code>
<ProductNDC>16714-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Palmitate Hydrochloride (pediatric)</ProprietaryName>
<NonProprietaryName>Clindamycin Palmitate Hydrochloride (pediatric)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202409</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PALMITATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin palmitate hydrochloride for oral solution (Pediatric) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution (Pediatric) and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution (Pediatric) 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.</IndicationAndUsage>
<Description>Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride. Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is white flavored granules containing clindamycin palmitate hydrochloride USP and becomes colorless to off-white with cherry flavored solution after reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, isopropyl alcohol, poloxamer, simethicone emulsion, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>16729-483-03</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (16729-483-03) / 5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>16729-0483-03</NDC11Code>
<ProductNDC>16729-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212868</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.,</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
<Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 4.0. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na +) and chloride (Cl -) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17H 23NO 3) 2H 2SO 4H 2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>16729-483-31</NDCCode>
<PackageDescription>5 mL in 1 SYRINGE, GLASS (16729-483-31) </PackageDescription>
<NDC11Code>16729-0483-31</NDC11Code>
<ProductNDC>16729-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212868</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.,</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
<Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 4.0. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na +) and chloride (Cl -) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17H 23NO 3) 2H 2SO 4H 2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>17205-483-00</NDCCode>
<PackageDescription>25 kg in 1 DRUM (17205-483-00) </PackageDescription>
<NDC11Code>17205-0483-00</NDC11Code>
<ProductNDC>17205-483</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20121212</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Siegfried AG</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>21130-483-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (21130-483-10) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0483-10</NDC11Code>
<ProductNDC>21130-483</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Day Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209094</ApplicationNumber>
<LabelerName>Safeway, Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21195-483-50</NDCCode>
<PackageDescription>820.5 kg in 1 PACKAGE (21195-483-50)</PackageDescription>
<NDC11Code>21195-0483-50</NDC11Code>
<ProductNDC>21195-483</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140506</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Kurita Water Industries (Jiangyin) Co., Ltd.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21195-483-51</NDCCode>
<PackageDescription>729.75 kg in 1 DRUM (21195-483-51)</PackageDescription>
<NDC11Code>21195-0483-51</NDC11Code>
<ProductNDC>21195-483</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140506</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Kurita Water Industries (Jiangyin) Co., Ltd.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21195-483-66</NDCCode>
<PackageDescription>130.5 kg in 1 PACKAGE (21195-483-66)</PackageDescription>
<NDC11Code>21195-0483-66</NDC11Code>
<ProductNDC>21195-483</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140506</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Kurita Water Industries (Jiangyin) Co., Ltd.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21695-483-30</NDCCode>
<PackageDescription>30 g in 1 TUBE (21695-483-30)</PackageDescription>
<NDC11Code>21695-0483-30</NDC11Code>
<ProductNDC>21695-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074407</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of propylene glycol, carbomer 934P, sodium hydroxide and purified water. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate, PEG 100 stearate, white wax, chlorocresol, sodium citrate anhydrous, citric acid anhydrous, and purified water. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>23155-483-31</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (23155-483-31) > 5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>23155-0483-31</NDC11Code>
<ProductNDC>23155-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine Hydrochloride</ProprietaryName>
<NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202063</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>25113-333-16</NDCCode>
<PackageDescription>483 g in 1 BOTTLE (25113-333-16)</PackageDescription>
<NDC11Code>25113-0333-16</NDC11Code>
<ProductNDC>25113-333</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germasidol</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>The Dodge Company Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.0057</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Antiseptic handwash for handwashing to decrease baceria on the skin.</IndicationAndUsage>
</NDC>
</NDCList>