{
"NDC": [
{
"NDCCode": "64980-653-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-653-50) ",
"NDC11Code": "64980-0653-50",
"ProductNDC": "64980-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075413",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP."
},
{
"NDCCode": "64980-653-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (64980-653-01) ",
"NDC11Code": "64980-0653-01",
"ProductNDC": "64980-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075413",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP."
},
{
"NDCCode": "64980-653-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (64980-653-06) ",
"NDC11Code": "64980-0653-06",
"ProductNDC": "64980-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075413",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP."
},
{
"NDCCode": "16714-653-01",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (16714-653-01) ",
"NDC11Code": "16714-0653-01",
"ProductNDC": "16714-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20070426",
"SamplePackage": "N"
},
{
"NDCCode": "50268-653-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-653-15) > 1 TABLET in 1 BLISTER PACK (50268-653-11) ",
"NDC11Code": "50268-0653-15",
"ProductNDC": "50268-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170724",
"EndMarketingDate": "20211031",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AvPAK",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170724",
"EndMarketingDatePackage": "20211031",
"SamplePackage": "N"
},
{
"NDCCode": "71919-653-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-653-09) ",
"NDC11Code": "71919-0653-09",
"ProductNDC": "71919-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulfur",
"NonProprietaryName": "Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SULFUR",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "75936-653-03",
"PackageDescription": "50 mL in 1 BOTTLE (75936-653-03) ",
"NDC11Code": "75936-0653-03",
"ProductNDC": "75936-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Play Everyday Face Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Supergoop, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 10; 5; 7.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "64980-177-50",
"PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (64980-177-50) ",
"NDC11Code": "64980-0177-50",
"ProductNDC": "64980-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chloroquine Phosphate",
"NonProprietaryName": "Chloroquine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091621",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CHLOROQUINE PHOSPHATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Chloroquine phosphate tablets are indicated for the: 1 Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax., 2 Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present., 3 Treatment of extraintestinal amebiasis.",
"Description": "Chloroquine phosphate tablet, USP, is a 4-aminoquinoline compound for oral administration. It is a white, odorless, bitter tasting, crystalline substance, freely soluble in water. Chloroquine phosphate tablet is an antimalarial and amebicidal drug. Chemically, it is 7-chloro-4-[[4- (diethylamino)-1-methylbutyl]amino] quinoline phosphate (1:2) and has the following structural formula. Each tablet contains 250 mg of chloroquine phosphate USP, equivalent to 150 mg chloroquine base. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "64980-228-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (64980-228-50) > 50 CAPSULE in 1 BOTTLE",
"NDC11Code": "64980-0228-50",
"ProductNDC": "64980-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxercalciferol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201518",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": ".5",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS], Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160909",
"SamplePackage": "N",
"IndicationAndUsage": "Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.",
"Description": "Doxercalciferol Capsules contains doxercalciferol, which is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is."
},
{
"NDCCode": "64980-229-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (64980-229-50) > 50 CAPSULE in 1 BOTTLE",
"NDC11Code": "64980-0229-50",
"ProductNDC": "64980-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxercalciferol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201518",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": "1",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS], Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160909",
"SamplePackage": "N",
"IndicationAndUsage": "Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.",
"Description": "Doxercalciferol Capsules contains doxercalciferol, which is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is."
},
{
"NDCCode": "64980-230-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (64980-230-50) > 50 CAPSULE in 1 BOTTLE",
"NDC11Code": "64980-0230-50",
"ProductNDC": "64980-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxercalciferol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201518",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": "2.5",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS], Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160909",
"SamplePackage": "N",
"IndicationAndUsage": "Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.",
"Description": "Doxercalciferol Capsules contains doxercalciferol, which is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is."
},
{
"NDCCode": "64980-236-50",
"PackageDescription": "50 TABLET in 1 BOTTLE (64980-236-50) ",
"NDC11Code": "64980-0236-50",
"ProductNDC": "64980-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205245",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160222",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. METRONIDAZOLE, USP is indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. METRONIDAZOLE, USP is indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners.T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with METRONIDAZOLE, USP in cases of reinfection. Amebiasis. METRONIDAZOLE, USP is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, METRONIDAZOLE, USP therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. METRONIDAZOLE, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with METRONIDAZOLE, USP therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to METRONIDAZOLE, USP. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of METRONIDAZOLE, USP and other antibacterial drugs, METRONIDAZOLE, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "METRONIDAZOLE, USP is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. METRONIDAZOLE Tablets, USP contain 250 mg or 500 mg of Metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil."
},
{
"NDCCode": "64980-305-50",
"PackageDescription": "51 g in 1 TUBE (64980-305-50) ",
"NDC11Code": "64980-0305-50",
"ProductNDC": "64980-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Denta 5000 Plus",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20120713",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120713",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Denta 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).",
"Description": "Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients."
},
{
"NDCCode": "64980-306-50",
"PackageDescription": "2 TUBE in 1 CARTON (64980-306-50) / 51 g in 1 TUBE",
"NDC11Code": "64980-0306-50",
"ProductNDC": "64980-306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Denta 5000 Plus",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20120713",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120713",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Denta 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).",
"Description": "Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients."
},
{
"NDCCode": "64980-342-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-342-50) ",
"NDC11Code": "64980-0342-50",
"ProductNDC": "64980-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090124",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240930",
"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 molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "64980-343-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64980-343-50) ",
"NDC11Code": "64980-0343-50",
"ProductNDC": "64980-343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090540",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120517",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets are a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome.",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9.The structural formula is as follows:. Clopidogrel bisulfate USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration are provided as pink colored, round, biconvex, beveled edge, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base.Each film-coated tablet contains crospovidone, hydrogenated castor oil, hydroxypropyl cellulose low substituted, hypromellose 15cP, iron oxide red, lactose monohydrate, mannitol, microcrystalline cellulose, polyethylene glycol 6000, titanium dioxide, and triacetin as inactive ingredients."
},
{
"NDCCode": "64980-362-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64980-362-50) ",
"NDC11Code": "64980-0362-50",
"ProductNDC": "64980-362",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090115",
"SamplePackage": "N"
},
{
"NDCCode": "64980-363-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64980-363-50) ",
"NDC11Code": "64980-0363-50",
"ProductNDC": "64980-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090115",
"SamplePackage": "N"
},
{
"NDCCode": "64980-364-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64980-364-50) ",
"NDC11Code": "64980-0364-50",
"ProductNDC": "64980-364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090115",
"SamplePackage": "N"
},
{
"NDCCode": "64980-366-05",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (64980-366-05) ",
"NDC11Code": "64980-0366-05",
"ProductNDC": "64980-366",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201043",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110620",
"SamplePackage": "N"
},
{
"NDCCode": "64980-367-05",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (64980-367-05) ",
"NDC11Code": "64980-0367-05",
"ProductNDC": "64980-367",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201043",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110620",
"SamplePackage": "N"
},
{
"NDCCode": "64980-381-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-381-50) ",
"NDC11Code": "64980-0381-50",
"ProductNDC": "64980-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040792",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090806",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
"Description": "Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "64980-390-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-390-50)",
"NDC11Code": "64980-0390-50",
"ProductNDC": "64980-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078021",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "64980-391-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-391-50)",
"NDC11Code": "64980-0391-50",
"ProductNDC": "64980-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078021",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "64980-392-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-392-50)",
"NDC11Code": "64980-0392-50",
"ProductNDC": "64980-392",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078021",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "64980-396-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-396-50) ",
"NDC11Code": "64980-0396-50",
"ProductNDC": "64980-396",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171107",
"SamplePackage": "N"
},
{
"NDCCode": "64980-397-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-397-50) ",
"NDC11Code": "64980-0397-50",
"ProductNDC": "64980-397",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171107",
"SamplePackage": "N"
},
{
"NDCCode": "64980-398-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-398-50) ",
"NDC11Code": "64980-0398-50",
"ProductNDC": "64980-398",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171107",
"SamplePackage": "N"
},
{
"NDCCode": "64980-399-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (64980-399-50) ",
"NDC11Code": "64980-0399-50",
"ProductNDC": "64980-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-03-11",
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"StartMarketingDatePackage": "20171107",
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"PackageDescription": "1 BOTTLE in 1 CARTON (64980-402-50) / 50 mL in 1 BOTTLE",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefpodoxime Proxetil",
"NonProprietaryName": "Cefpodoxime Proxetil",
"DosageFormName": "GRANULE, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065409",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CEFPODOXIME PROXETIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
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"IndicationAndUsage": "Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase producing strains).Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available.Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION.)Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil’s lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil and other antibacterial drugs, cefpodoxime proxetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene- 2-carboxylate.Its molecular formula is C21H27N5O9S2 and its structural formula is represented below. The molecular weight of cefpodoxime proxetil is 557.6. Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as flavoured granules for oral suspension.Each 5 mL of cefpodoxime proxetil for oral suspension USP contains cefpodoxime proxetil USP equivalent to 50 mg or 100 mg of cefpodoxime activity after constitution and the following inactive ingredients: lactose monohydrate, corn starch, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, microcrystalline cellulose and carboxymethyl cellulose sodium, colloidal silicon dioxide, citric acid anhydrous, sodium citrate, sodium benzoate, sucrose, and citron & vanille flavorings."
}
]
}
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP.</Description>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-20</LastUpdate>
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<LabelerName>AvPAK</LabelerName>
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<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-11-03</LastUpdate>
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<LastUpdate>2022-03-26</LastUpdate>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Play Everyday Face Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Supergoop, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
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<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CHLOROQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chloroquine phosphate tablets are indicated for the: 1 Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax., 2 Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present., 3 Treatment of extraintestinal amebiasis.</IndicationAndUsage>
<Description>Chloroquine phosphate tablet, USP, is a 4-aminoquinoline compound for oral administration. It is a white, odorless, bitter tasting, crystalline substance, freely soluble in water. Chloroquine phosphate tablet is an antimalarial and amebicidal drug. Chemically, it is 7-chloro-4-[[4- (diethylamino)-1-methylbutyl]amino] quinoline phosphate (1:2) and has the following structural formula. Each tablet contains 250 mg of chloroquine phosphate USP, equivalent to 150 mg chloroquine base. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate.</Description>
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<NDC>
<NDCCode>64980-228-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64980-228-50) > 50 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>64980-0228-50</NDC11Code>
<ProductNDC>64980-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxercalciferol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201518</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.</IndicationAndUsage>
<Description>Doxercalciferol Capsules contains doxercalciferol, which is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>64980-229-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64980-229-50) > 50 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>64980-0229-50</NDC11Code>
<ProductNDC>64980-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxercalciferol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201518</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.</IndicationAndUsage>
<Description>Doxercalciferol Capsules contains doxercalciferol, which is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>64980-230-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64980-230-50) > 50 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>64980-0230-50</NDC11Code>
<ProductNDC>64980-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxercalciferol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201518</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.</IndicationAndUsage>
<Description>Doxercalciferol Capsules contains doxercalciferol, which is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>64980-236-50</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (64980-236-50) </PackageDescription>
<NDC11Code>64980-0236-50</NDC11Code>
<ProductNDC>64980-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205245</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. METRONIDAZOLE, USP is indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. METRONIDAZOLE, USP is indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners.T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with METRONIDAZOLE, USP in cases of reinfection. Amebiasis. METRONIDAZOLE, USP is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, METRONIDAZOLE, USP therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. METRONIDAZOLE, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with METRONIDAZOLE, USP therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to METRONIDAZOLE, USP. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of METRONIDAZOLE, USP and other antibacterial drugs, METRONIDAZOLE, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>METRONIDAZOLE, USP is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. METRONIDAZOLE Tablets, USP contain 250 mg or 500 mg of Metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil.</Description>
</NDC>
<NDC>
<NDCCode>64980-305-50</NDCCode>
<PackageDescription>51 g in 1 TUBE (64980-305-50) </PackageDescription>
<NDC11Code>64980-0305-50</NDC11Code>
<ProductNDC>64980-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Denta 5000 Plus</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120713</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120713</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Denta 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).</IndicationAndUsage>
<Description>Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients.</Description>
</NDC>
<NDC>
<NDCCode>64980-306-50</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (64980-306-50) / 51 g in 1 TUBE</PackageDescription>
<NDC11Code>64980-0306-50</NDC11Code>
<ProductNDC>64980-306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Denta 5000 Plus</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120713</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120713</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Denta 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).</IndicationAndUsage>
<Description>Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients.</Description>
</NDC>
<NDC>
<NDCCode>64980-342-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-342-50) </PackageDescription>
<NDC11Code>64980-0342-50</NDC11Code>
<ProductNDC>64980-342</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>ANDA090124</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, 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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</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 molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>64980-343-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64980-343-50) </PackageDescription>
<NDC11Code>64980-0343-50</NDC11Code>
<ProductNDC>64980-343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090540</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets are a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome.</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9.The structural formula is as follows:. Clopidogrel bisulfate USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration are provided as pink colored, round, biconvex, beveled edge, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base.Each film-coated tablet contains crospovidone, hydrogenated castor oil, hydroxypropyl cellulose low substituted, hypromellose 15cP, iron oxide red, lactose monohydrate, mannitol, microcrystalline cellulose, polyethylene glycol 6000, titanium dioxide, and triacetin as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>64980-362-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64980-362-50) </PackageDescription>
<NDC11Code>64980-0362-50</NDC11Code>
<ProductNDC>64980-362</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-363-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64980-363-50) </PackageDescription>
<NDC11Code>64980-0363-50</NDC11Code>
<ProductNDC>64980-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-364-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64980-364-50) </PackageDescription>
<NDC11Code>64980-0364-50</NDC11Code>
<ProductNDC>64980-364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-366-05</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (64980-366-05) </PackageDescription>
<NDC11Code>64980-0366-05</NDC11Code>
<ProductNDC>64980-366</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201043</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-367-05</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (64980-367-05) </PackageDescription>
<NDC11Code>64980-0367-05</NDC11Code>
<ProductNDC>64980-367</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201043</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-381-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-381-50) </PackageDescription>
<NDC11Code>64980-0381-50</NDC11Code>
<ProductNDC>64980-381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040792</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.Limitation of UseCarisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol tablets, USP are available as 250 mg and 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in the carisoprodol tablets, USP include pregelatinized starch (maize), crospovidone, povidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>64980-390-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-390-50)</PackageDescription>
<NDC11Code>64980-0390-50</NDC11Code>
<ProductNDC>64980-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078021</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64980-391-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-391-50)</PackageDescription>
<NDC11Code>64980-0391-50</NDC11Code>
<ProductNDC>64980-391</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078021</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64980-392-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-392-50)</PackageDescription>
<NDC11Code>64980-0392-50</NDC11Code>
<ProductNDC>64980-392</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078021</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64980-396-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-396-50) </PackageDescription>
<NDC11Code>64980-0396-50</NDC11Code>
<ProductNDC>64980-396</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-397-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-397-50) </PackageDescription>
<NDC11Code>64980-0397-50</NDC11Code>
<ProductNDC>64980-397</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-398-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-398-50) </PackageDescription>
<NDC11Code>64980-0398-50</NDC11Code>
<ProductNDC>64980-398</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-399-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64980-399-50) </PackageDescription>
<NDC11Code>64980-0399-50</NDC11Code>
<ProductNDC>64980-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-402-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64980-402-50) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>64980-0402-50</NDC11Code>
<ProductNDC>64980-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefpodoxime Proxetil</ProprietaryName>
<NonProprietaryName>Cefpodoxime Proxetil</NonProprietaryName>
<DosageFormName>GRANULE, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065409</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CEFPODOXIME PROXETIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase producing strains).Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefpodoxime proxetil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefpodoxime proxetil for the prophylaxis of subsequent rheumatic fever are not available.Community-acquired pneumonia caused by S. pneumoniae or H. Influenzae (including beta-lactamase-producing strains).Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis. Data are insufficient at this time to establish efficacy in patients with acute bacterial exacerbations of chronic bronchitis caused by beta-lactamase-producing strains of H. influenzae.Acute, uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).Acute, uncomplicated ano-rectal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).NOTE: The efficacy of cefpodoxime in treating male patients with rectal infections caused by N. gonorrhoeae has not been established. Data do not support the use of cefpodoxime proxetil in the treatment of pharyngeal infections due to N. gonorrhoeae in men or women.Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or Streptococcus pyogenes. Abscesses should be surgically drained as clinically indicated.NOTE: In clinical trials, successful treatment of uncomplicated skin and skin structure infections was dose-related. The effective therapeutic dose for skin infections was higher than those used in other recommended indications. (See DOSAGE AND ADMINISTRATION.)Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Moraxella catarrhalis.Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.NOTE: In considering the use of cefpodoxime proxetil in the treatment of cystitis, cefpodoxime proxetil’s lower bacterial eradication rates should be weighed against the increased eradication rates and different safety profiles of some other classes of approved agents. (See CLINICAL STUDIES section.)Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil and other antibacterial drugs, cefpodoxime proxetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene- 2-carboxylate.Its molecular formula is C21H27N5O9S2 and its structural formula is represented below. The molecular weight of cefpodoxime proxetil is 557.6. Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as flavoured granules for oral suspension.Each 5 mL of cefpodoxime proxetil for oral suspension USP contains cefpodoxime proxetil USP equivalent to 50 mg or 100 mg of cefpodoxime activity after constitution and the following inactive ingredients: lactose monohydrate, corn starch, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, microcrystalline cellulose and carboxymethyl cellulose sodium, colloidal silicon dioxide, citric acid anhydrous, sodium citrate, sodium benzoate, sucrose, and citron & vanille flavorings.</Description>
</NDC>
</NDCList>