{
"NDC": [
{
"NDCCode": "69097-146-06",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-146-06) ",
"NDC11Code": "69097-0146-06",
"ProductNDC": "69097-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077215",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181207",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
},
{
"NDCCode": "69097-146-02",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-146-02) ",
"NDC11Code": "69097-0146-02",
"ProductNDC": "69097-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077215",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181207",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
},
{
"NDCCode": "69097-146-12",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (69097-146-12) ",
"NDC11Code": "69097-0146-12",
"ProductNDC": "69097-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077215",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181207",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
},
{
"NDCCode": "69097-143-06",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-143-06) ",
"NDC11Code": "69097-0143-06",
"ProductNDC": "69097-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077215",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "2.5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181207",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
},
{
"NDCCode": "69097-144-06",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-144-06) ",
"NDC11Code": "69097-0144-06",
"ProductNDC": "69097-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077215",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181207",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
},
{
"NDCCode": "69097-145-06",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-145-06) ",
"NDC11Code": "69097-0145-06",
"ProductNDC": "69097-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077215",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181207",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
},
{
"NDCCode": "32909-146-06",
"PackageDescription": "6 JUG in 1 CASE (32909-146-06) / 600 mL in 1 JUG",
"NDC11Code": "32909-0146-06",
"ProductNDC": "32909-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Entero Vu 24%",
"NonProprietaryName": "Barium Sulfate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208143",
"LabelerName": "E-Z-EM Canada Inc",
"SubstanceName": "BARIUM SULFATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "ENTERO VU 24% is indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients.",
"Description": "ENTERO VU 24% (barium sulfate) is a radiographic contrast agent that is supplied as a suspension (24% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. ENTERO VU 24% contains the following excipients: acacia, carrageenan, citric acid, methylcellulose, natural and artificial blueberry flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, and xanthan gum."
},
{
"NDCCode": "46362-001-06",
"PackageDescription": "146 L in 1 CYLINDER (46362-001-06) ",
"NDC11Code": "46362-0001-06",
"ProductNDC": "46362-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19860101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205865",
"LabelerName": "Red Ball Oxygen Co., Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19860101",
"SamplePackage": "N"
},
{
"NDCCode": "51009-146-06",
"PackageDescription": "1 TUBE in 1 BOX (51009-146-06) > 147.4 g in 1 TUBE",
"NDC11Code": "51009-0146-06",
"ProductNDC": "51009-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Long-lasting Wicked Fresh - Cool Peppermint",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20091130",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Tom's of Maine, Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".0076",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "51862-146-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (51862-146-06) ",
"NDC11Code": "51862-0146-06",
"ProductNDC": "51862-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selegiline Hydrochloride",
"NonProprietaryName": "Selegiline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140524",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074912",
"LabelerName": "Mayne Pharma",
"SubstanceName": "SELEGILINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140524",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "53247-146-06",
"PackageDescription": "1 TUBE in 1 CARTON (53247-146-06) / 130 g in 1 TUBE",
"NDC11Code": "53247-0146-06",
"ProductNDC": "53247-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meridian Anticavity Fluoride",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20260914",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "7.6",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260914",
"SamplePackage": "N",
"IndicationAndUsage": "Helps protect against cavities."
},
{
"NDCCode": "57344-146-06",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (57344-146-06)",
"NDC11Code": "57344-0146-06",
"ProductNDC": "57344-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121215",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "AAA Pharmaceutical, Inc.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "64220-146-06",
"PackageDescription": "15 kg in 1 DRUM (64220-146-06) ",
"NDC11Code": "64220-0146-06",
"ProductNDC": "64220-146",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240604",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-06-05",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-JUN-24"
},
{
"NDCCode": "65219-146-10",
"PackageDescription": "10 BAG in 1 CASE (65219-146-10) / 1000 mL in 1 BAG (65219-146-06) ",
"NDC11Code": "65219-0146-10",
"ProductNDC": "65219-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213523",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "50; 4.5; 2.24",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220826",
"SamplePackage": "N",
"IndicationAndUsage": "These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.",
"Description": "Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex ® bag) . Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "67751-146-06",
"PackageDescription": "3 POUCH in 1 CARTON (67751-146-06) / 2 TABLET, COATED in 1 POUCH",
"NDC11Code": "67751-0146-06",
"ProductNDC": "67751-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Advil",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018989",
"LabelerName": "Navajo Manufacturing Company Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250421",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily relieves minor aches and pains due to: headache toothache backache the common cold muscular aches minor pain of arthritis menstrual cramps temporarily reduces fever."
},
{
"NDCCode": "68382-146-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68382-146-06) ",
"NDC11Code": "68382-0146-06",
"ProductNDC": "68382-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078832",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101120",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. Ramipril, USP is a white to almost white crystalline powder. It is freely soluble in methanol and sparingly soluble in water. Ramipril melts between 105°C and 112° C. Ramipril’s chemical name is (2S, 3aS, 6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1 -ethyl ester; its structural formula is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Each ramipril capsule, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg or 10 mg of ramipril, USP. In addition, each capsule contains the following inactive ingredients: gelatin, pregelatinized starch and titanium dioxide. Additionally each 1.25 mg capsule shell contains: FD&C red # 40, FD&C yellow # 5 and FD&C yellow # 6, 2.5 mg capsule shell contains: D&C yellow # 10 and FD&C red # 40, 5 mg capsule shell contains: FD&C blue # 1, FD&C red # 40 and FD&C yellow # 6 and 10 mg capsule shell contains:, D&C red # 28, D&C yellow # 10 and FD&C blue # 1. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "72789-146-06",
"PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-146-06) ",
"NDC11Code": "72789-0146-06",
"ProductNDC": "72789-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065435",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201230",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections– penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis). Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association 1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "82804-146-06",
"PackageDescription": "6 TABLET in 1 BOTTLE (82804-146-06) ",
"NDC11Code": "82804-0146-06",
"ProductNDC": "82804-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077731",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250908",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see Error! Hyperlink reference not valid. section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "83589-146-06",
"PackageDescription": "50 g in 1 BOTTLE (83589-146-06) ",
"NDC11Code": "83589-0146-06",
"ProductNDC": "83589-146",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ara290 Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260225",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "CIBINETIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "25-FEB-26"
},
{
"NDCCode": "69097-142-60",
"PackageDescription": "1 CANISTER in 1 CARTON (69097-142-60) / 200 INHALANT in 1 CANISTER",
"NDC11Code": "69097-0142-60",
"ProductNDC": "69097-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209959",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.",
"Description": "The active component of Albuterol sulfate inhalation aerosol is albuterol sulfate, USP racemic α1[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta2-adrenergic bronchodilator having the following chemical structure:. Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate inhalation aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four \"test sprays\" into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant."
},
{
"NDCCode": "69097-173-53",
"PackageDescription": "6 POUCH in 1 CARTON (69097-173-53) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL",
"NDC11Code": "69097-0173-53",
"ProductNDC": "69097-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077559",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE",
"StrengthNumber": "2.5; .5",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071231",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β2-adrenergic bronchodilator chemically described as α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3 1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8 -azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3. 1-2. Chemical structure of ipratropium bromide. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride, hydrochloric acid to adjust to pH 4, and edetate disodium, USP (a chelating agent). Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution,USP like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "69097-173-64",
"PackageDescription": "12 POUCH in 1 CARTON (69097-173-64) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL",
"NDC11Code": "69097-0173-64",
"ProductNDC": "69097-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077559",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE",
"StrengthNumber": "2.5; .5",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071231",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β2-adrenergic bronchodilator chemically described as α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3 1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8 -azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3. 1-2. Chemical structure of ipratropium bromide. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride, hydrochloric acid to adjust to pH 4, and edetate disodium, USP (a chelating agent). Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution,USP like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "69097-218-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69097-218-02) ",
"NDC11Code": "69097-0218-02",
"ProductNDC": "69097-218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prucalopride",
"NonProprietaryName": "Prucalopride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218795",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PRUCALOPRIDE SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
"Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is freely soluble in water, sparingly soluble in methanol and slightly soluble in N, N-Dimethyl acetamide. Each film-coated tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin. Each film-coated tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide."
},
{
"NDCCode": "69097-219-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69097-219-02) ",
"NDC11Code": "69097-0219-02",
"ProductNDC": "69097-219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prucalopride",
"NonProprietaryName": "Prucalopride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218795",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PRUCALOPRIDE SUCCINATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
"Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is freely soluble in water, sparingly soluble in methanol and slightly soluble in N, N-Dimethyl acetamide. Each film-coated tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin. Each film-coated tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide."
},
{
"NDCCode": "69097-223-16",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69097-223-16) / 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "69097-0223-16",
"ProductNDC": "69097-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076768",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch."
},
{
"NDCCode": "69097-223-76",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69097-223-76) / 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "69097-0223-76",
"ProductNDC": "69097-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076768",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch."
},
{
"NDCCode": "69097-224-16",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69097-224-16) / 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "69097-0224-16",
"ProductNDC": "69097-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076768",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch."
},
{
"NDCCode": "69097-224-76",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "69097-0224-76",
"ProductNDC": "69097-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076768",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch."
},
{
"NDCCode": "69097-227-12",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (69097-227-12) ",
"NDC11Code": "69097-0227-12",
"ProductNDC": "69097-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"EndMarketingDate": "20190531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "Cipla USA, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19840911",
"EndMarketingDatePackage": "20190531",
"SamplePackage": "N"
},
{
"NDCCode": "69097-318-53",
"PackageDescription": "30 POUCH in 1 CARTON (69097-318-53) / 1 AMPULE in 1 POUCH (69097-318-32) / 2 mL in 1 AMPULE",
"NDC11Code": "69097-0318-53",
"ProductNDC": "69097-318",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Budesonide",
"ProprietaryNameSuffix": "Inhalation Suspension",
"NonProprietaryName": "Budesonide",
"DosageFormName": "INHALANT",
"RouteName": "ORAL",
"StartMarketingDate": "20171116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205710",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201015",
"SamplePackage": "N",
"IndicationAndUsage": "Budesonide inhalation suspension is an inhaled corticosteroid indicated for:. Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1). Limitations of Use:. Not indicated for the relief of acute bronchospasm (1).",
"Description": "Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)]."
}
]
}
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<NDCList>
<NDC>
<NDCCode>69097-146-06</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (69097-146-06) </PackageDescription>
<NDC11Code>69097-0146-06</NDC11Code>
<ProductNDC>69097-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077215</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40.</Description>
</NDC>
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<NDCCode>69097-146-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-146-02) </PackageDescription>
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<ProductNDC>69097-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077215</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40.</Description>
</NDC>
<NDC>
<NDCCode>69097-146-12</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (69097-146-12) </PackageDescription>
<NDC11Code>69097-0146-12</NDC11Code>
<ProductNDC>69097-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077215</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40.</Description>
</NDC>
<NDC>
<NDCCode>69097-143-06</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (69097-143-06) </PackageDescription>
<NDC11Code>69097-0143-06</NDC11Code>
<ProductNDC>69097-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077215</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40.</Description>
</NDC>
<NDC>
<NDCCode>69097-144-06</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (69097-144-06) </PackageDescription>
<NDC11Code>69097-0144-06</NDC11Code>
<ProductNDC>69097-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077215</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40.</Description>
</NDC>
<NDC>
<NDCCode>69097-145-06</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (69097-145-06) </PackageDescription>
<NDC11Code>69097-0145-06</NDC11Code>
<ProductNDC>69097-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077215</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40.</Description>
</NDC>
<NDC>
<NDCCode>32909-146-06</NDCCode>
<PackageDescription>6 JUG in 1 CASE (32909-146-06) / 600 mL in 1 JUG</PackageDescription>
<NDC11Code>32909-0146-06</NDC11Code>
<ProductNDC>32909-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Entero Vu 24%</ProprietaryName>
<NonProprietaryName>Barium Sulfate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208143</ApplicationNumber>
<LabelerName>E-Z-EM Canada Inc</LabelerName>
<SubstanceName>BARIUM SULFATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENTERO VU 24% is indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients.</IndicationAndUsage>
<Description>ENTERO VU 24% (barium sulfate) is a radiographic contrast agent that is supplied as a suspension (24% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3, and the following chemical structure. ENTERO VU 24% contains the following excipients: acacia, carrageenan, citric acid, methylcellulose, natural and artificial blueberry flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, and xanthan gum.</Description>
</NDC>
<NDC>
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<PackageDescription>146 L in 1 CYLINDER (46362-001-06) </PackageDescription>
<NDC11Code>46362-0001-06</NDC11Code>
<ProductNDC>46362-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19860101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205865</ApplicationNumber>
<LabelerName>Red Ball Oxygen Co., Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51009-146-06</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (51009-146-06) > 147.4 g in 1 TUBE</PackageDescription>
<NDC11Code>51009-0146-06</NDC11Code>
<ProductNDC>51009-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Long-lasting Wicked Fresh - Cool Peppermint</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20091130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Tom's of Maine, Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.0076</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51862-146-06</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (51862-146-06) </PackageDescription>
<NDC11Code>51862-0146-06</NDC11Code>
<ProductNDC>51862-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selegiline Hydrochloride</ProprietaryName>
<NonProprietaryName>Selegiline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140524</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074912</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>SELEGILINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140524</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53247-146-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (53247-146-06) / 130 g in 1 TUBE</PackageDescription>
<NDC11Code>53247-0146-06</NDC11Code>
<ProductNDC>53247-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meridian Anticavity Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20260914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Bob Barker Company Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>7.6</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57344-146-06</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (57344-146-06)</PackageDescription>
<NDC11Code>57344-0146-06</NDC11Code>
<ProductNDC>57344-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64220-146-06</NDCCode>
<PackageDescription>15 kg in 1 DRUM (64220-146-06) </PackageDescription>
<NDC11Code>64220-0146-06</NDC11Code>
<ProductNDC>64220-146</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240604</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-06-05</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-JUN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65219-146-10</NDCCode>
<PackageDescription>10 BAG in 1 CASE (65219-146-10) / 1000 mL in 1 BAG (65219-146-06) </PackageDescription>
<NDC11Code>65219-0146-10</NDC11Code>
<ProductNDC>65219-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213523</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>50; 4.5; 2.24</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.</IndicationAndUsage>
<Description>Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula:. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex ® bag) . Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>67751-146-06</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (67751-146-06) / 2 TABLET, COATED in 1 POUCH</PackageDescription>
<NDC11Code>67751-0146-06</NDC11Code>
<ProductNDC>67751-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Advil</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018989</ApplicationNumber>
<LabelerName>Navajo Manufacturing Company Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves minor aches and pains due to: headache toothache backache the common cold muscular aches minor pain of arthritis menstrual cramps temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68382-146-06</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68382-146-06) </PackageDescription>
<NDC11Code>68382-0146-06</NDC11Code>
<ProductNDC>68382-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078832</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. Ramipril, USP is a white to almost white crystalline powder. It is freely soluble in methanol and sparingly soluble in water. Ramipril melts between 105°C and 112° C. Ramipril’s chemical name is (2S, 3aS, 6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1 -ethyl ester; its structural formula is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Each ramipril capsule, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg or 10 mg of ramipril, USP. In addition, each capsule contains the following inactive ingredients: gelatin, pregelatinized starch and titanium dioxide. Additionally each 1.25 mg capsule shell contains: FD&C red # 40, FD&C yellow # 5 and FD&C yellow # 6, 2.5 mg capsule shell contains: D&C yellow # 10 and FD&C red # 40, 5 mg capsule shell contains: FD&C blue # 1, FD&C red # 40 and FD&C yellow # 6 and 10 mg capsule shell contains:, D&C red # 28, D&C yellow # 10 and FD&C blue # 1. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72789-146-06</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-146-06) </PackageDescription>
<NDC11Code>72789-0146-06</NDC11Code>
<ProductNDC>72789-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065435</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections– penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis). Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association 1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>82804-146-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE (82804-146-06) </PackageDescription>
<NDC11Code>82804-0146-06</NDC11Code>
<ProductNDC>82804-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077731</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see Error! Hyperlink reference not valid. section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83589-146-06</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (83589-146-06) </PackageDescription>
<NDC11Code>83589-0146-06</NDC11Code>
<ProductNDC>83589-146</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ara290 Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260225</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>CIBINETIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-FEB-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69097-142-60</NDCCode>
<PackageDescription>1 CANISTER in 1 CARTON (69097-142-60) / 200 INHALANT in 1 CANISTER</PackageDescription>
<NDC11Code>69097-0142-60</NDC11Code>
<ProductNDC>69097-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209959</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.</IndicationAndUsage>
<Description>The active component of Albuterol sulfate inhalation aerosol is albuterol sulfate, USP racemic α1[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta2-adrenergic bronchodilator having the following chemical structure:. Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate inhalation aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four "test sprays" into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant.</Description>
</NDC>
<NDC>
<NDCCode>69097-173-53</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (69097-173-53) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>69097-0173-53</NDC11Code>
<ProductNDC>69097-173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077559</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE; IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>2.5; .5</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β2-adrenergic bronchodilator chemically described as α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3 1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8 -azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3. 1-2. Chemical structure of ipratropium bromide. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride, hydrochloric acid to adjust to pH 4, and edetate disodium, USP (a chelating agent). Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution,USP like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>69097-173-64</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (69097-173-64) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>69097-0173-64</NDC11Code>
<ProductNDC>69097-173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077559</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE; IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>2.5; .5</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β2-adrenergic bronchodilator chemically described as α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H21NO3)2H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3 1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8 -azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3. 1-2. Chemical structure of ipratropium bromide. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride, hydrochloric acid to adjust to pH 4, and edetate disodium, USP (a chelating agent). Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution,USP like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>69097-218-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69097-218-02) </PackageDescription>
<NDC11Code>69097-0218-02</NDC11Code>
<ProductNDC>69097-218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prucalopride</ProprietaryName>
<NonProprietaryName>Prucalopride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218795</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
<Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is freely soluble in water, sparingly soluble in methanol and slightly soluble in N, N-Dimethyl acetamide. Each film-coated tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin. Each film-coated tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>69097-219-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69097-219-02) </PackageDescription>
<NDC11Code>69097-0219-02</NDC11Code>
<ProductNDC>69097-219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prucalopride</ProprietaryName>
<NonProprietaryName>Prucalopride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218795</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
<Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is. Prucalopride succinate is a white to almost white powder. It is freely soluble in water, sparingly soluble in methanol and slightly soluble in N, N-Dimethyl acetamide. Each film-coated tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin. Each film-coated tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>69097-223-16</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69097-223-16) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69097-0223-16</NDC11Code>
<ProductNDC>69097-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076768</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.</Description>
</NDC>
<NDC>
<NDCCode>69097-223-76</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69097-223-76) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69097-0223-76</NDC11Code>
<ProductNDC>69097-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076768</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.</Description>
</NDC>
<NDC>
<NDCCode>69097-224-16</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69097-224-16) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69097-0224-16</NDC11Code>
<ProductNDC>69097-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076768</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.</Description>
</NDC>
<NDC>
<NDCCode>69097-224-76</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69097-0224-76</NDC11Code>
<ProductNDC>69097-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076768</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.</Description>
</NDC>
<NDC>
<NDCCode>69097-227-12</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (69097-227-12) </PackageDescription>
<NDC11Code>69097-0227-12</NDC11Code>
<ProductNDC>69097-227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840911</StartMarketingDate>
<EndMarketingDate>20190531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062505</ApplicationNumber>
<LabelerName>Cipla USA, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19840911</StartMarketingDatePackage>
<EndMarketingDatePackage>20190531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-318-53</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (69097-318-53) / 1 AMPULE in 1 POUCH (69097-318-32) / 2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>69097-0318-53</NDC11Code>
<ProductNDC>69097-318</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Budesonide</ProprietaryName>
<ProprietaryNameSuffix>Inhalation Suspension</ProprietaryNameSuffix>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205710</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Budesonide inhalation suspension is an inhaled corticosteroid indicated for:. Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1). Limitations of Use:. Not indicated for the relief of acute bronchospasm (1).</IndicationAndUsage>
<Description>Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)].</Description>
</NDC>
</NDCList>