{
"NDC": [
{
"NDCCode": "49884-322-55",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (49884-322-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-322-52) ",
"NDC11Code": "49884-0322-55",
"ProductNDC": "49884-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20111024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078109",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111024",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2."
},
{
"NDCCode": "43744-322-55",
"PackageDescription": "500 g in 1 DRUM (43744-322-55)",
"NDC11Code": "43744-0322-55",
"ProductNDC": "43744-322",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Doxapram Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120404",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "DOXAPRAM HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "59886-322-55",
"PackageDescription": "250 g in 1 BOTTLE, PLASTIC (59886-322-55)",
"NDC11Code": "59886-0322-55",
"ProductNDC": "59886-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ultrasolsunscreen",
"ProprietaryNameSuffix": "Sunscreen Lotion Spf45",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fischer Pharmaceuticals Ltd",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "2; 7.5; 5; 4",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69758-322-55",
"PackageDescription": "50 g in 1 JAR (69758-322-55)",
"NDC11Code": "69758-0322-55",
"ProductNDC": "69758-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemotreat",
"NonProprietaryName": "White Petrolatum, Lanolin, Hard Fat, Camphor",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150515",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Global Treat srl",
"SubstanceName": "PETROLATUM; LANOLIN; FAT, HARD; CAMPHOR (SYNTHETIC)",
"StrengthNumber": ".213; .212; .426; .025",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2018-02-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49884-212-55",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (49884-212-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-212-52) ",
"NDC11Code": "49884-0212-55",
"ProductNDC": "49884-212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077494",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090601",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone Orally Disintegrating Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCI. Risperidone Orally Disintegrating Tablets, USP are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths and are white in color. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: aspartame, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, mannitol, methacrylic acid polymer with divinylbenzene, modified food starch, silicon dioxide, sorbitol, talc, tartaric acid, and natural grapefruit flavor. This product meets USP Disintegration Test 2."
},
{
"NDCCode": "49884-311-55",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (49884-311-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "49884-0311-55",
"ProductNDC": "49884-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077494",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090601",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone Orally Disintegrating Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCI. Risperidone Orally Disintegrating Tablets, USP are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths and are white in color. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: aspartame, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, mannitol, methacrylic acid polymer with divinylbenzene, modified food starch, silicon dioxide, sorbitol, talc, tartaric acid, and natural grapefruit flavor. This product meets USP Disintegration Test 2."
},
{
"NDCCode": "49884-315-55",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (49884-315-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "49884-0315-55",
"ProductNDC": "49884-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20091026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077494",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091026",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone Orally Disintegrating Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCI. Risperidone Orally Disintegrating Tablets, USP are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths and are white in color. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: aspartame, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, mannitol, methacrylic acid polymer with divinylbenzene, modified food starch, silicon dioxide, sorbitol, talc, tartaric acid, and natural grapefruit flavor. This product meets USP Disintegration Test 2."
},
{
"NDCCode": "49884-320-55",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (49884-320-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-320-52) ",
"NDC11Code": "49884-0320-55",
"ProductNDC": "49884-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20111024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078109",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111024",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2."
},
{
"NDCCode": "49884-321-55",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (49884-321-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-321-52) ",
"NDC11Code": "49884-0321-55",
"ProductNDC": "49884-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20111024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078109",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111024",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2."
},
{
"NDCCode": "49884-323-55",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (49884-323-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-323-52) ",
"NDC11Code": "49884-0323-55",
"ProductNDC": "49884-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20111024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078109",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111024",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2."
},
{
"NDCCode": "49884-459-55",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (49884-459-55) > 1 LOZENGE in 1 BLISTER PACK (49884-459-52)",
"NDC11Code": "49884-0459-55",
"ProductNDC": "49884-459",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077312",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-460-55",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (49884-460-55) > 1 LOZENGE in 1 BLISTER PACK (49884-460-52)",
"NDC11Code": "49884-0460-55",
"ProductNDC": "49884-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077312",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-461-55",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (49884-461-55) > 1 LOZENGE in 1 BLISTER PACK (49884-461-52)",
"NDC11Code": "49884-0461-55",
"ProductNDC": "49884-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077312",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-462-55",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (49884-462-55) > 1 LOZENGE in 1 BLISTER PACK (49884-462-52)",
"NDC11Code": "49884-0462-55",
"ProductNDC": "49884-462",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077312",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "800",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-463-55",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (49884-463-55) > 1 LOZENGE in 1 BLISTER PACK (49884-463-52)",
"NDC11Code": "49884-0463-55",
"ProductNDC": "49884-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077312",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-464-55",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (49884-464-55) > 1 LOZENGE in 1 BLISTER PACK (49884-464-52)",
"NDC11Code": "49884-0464-55",
"ProductNDC": "49884-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077312",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49884-701-55",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (49884-701-55) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "49884-0701-55",
"ProductNDC": "49884-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomiphene Citrate",
"NonProprietaryName": "Clomiphene Citrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990830",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075528",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "CLOMIPHENE CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990920",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.). Clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below. 1. Patients who are not pregnant.2. Patients without ovarian cysts. Clomiphene citrate should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate treatment.3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present.4. Patients with normal liver function. In addition, patients selected for clomiphene citrate therapy should be evaluated in regard to the following. 1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy.2. Primary Pituitary or Ovarian Failure. Clomiphene citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure.3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to clomiphene citrate therapy in this population.4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility.5. Uterine Fibroids. Caution should be exercised when using clomiphene citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene citrate is not known. Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation-inducing drugs). Similarly, there is no standard clomiphene citrate regimen for ovulation induction in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate is not recommended for these uses.",
"Description": "Clomiphene Citrate Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C26H28CINO C6H8O7 and a molecular weight of 598.10. It is represented structurally as. Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white debossed tablet contains 50 mg clomiphene citrate USP. The tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose."
},
{
"NDCCode": "49884-903-55",
"PackageDescription": "30 TABLET in 1 CARTON (49884-903-55) ",
"NDC11Code": "49884-0903-55",
"ProductNDC": "49884-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20161104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201509",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161104",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14)]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem tartrate sublingual tablets contains zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate sublingual tablets are available in 5 mg and 10 mg strength tablets for sublingual administration. Chemically, zolpidem tartrate, USP is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white or almost white, crystalline, hygroscopic powder that is slightly soluble in water, sparingly soluble in methanol, and practically insoluble in methylene chloride. It has a molecular weight of 764.87. Each zolpidem tartrate sublingual tablet includes the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch and saccharin sodium."
},
{
"NDCCode": "49884-904-55",
"PackageDescription": "30 TABLET in 1 CARTON (49884-904-55) ",
"NDC11Code": "49884-0904-55",
"ProductNDC": "49884-904",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20161104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201509",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161104",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14)]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem tartrate sublingual tablets contains zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate sublingual tablets are available in 5 mg and 10 mg strength tablets for sublingual administration. Chemically, zolpidem tartrate, USP is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white or almost white, crystalline, hygroscopic powder that is slightly soluble in water, sparingly soluble in methanol, and practically insoluble in methylene chloride. It has a molecular weight of 764.87. Each zolpidem tartrate sublingual tablet includes the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch and saccharin sodium."
},
{
"NDCCode": "27808-322-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27808-322-01) ",
"NDC11Code": "27808-0322-01",
"ProductNDC": "27808-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219073",
"LabelerName": "Cranbury Pharmaceuticals, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is (+)-5-[2-(Dimethylamino)ethyl]-cis-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one acetate (ester) monohydrochloride. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride, USP (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride, USP (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem). Inactive ingredients: gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer, povidone, red iron oxide, silicon dioxide, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP. For oral administration."
},
{
"NDCCode": "64950-322-47",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (64950-322-47) ",
"NDC11Code": "64950-0322-47",
"ProductNDC": "64950-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206814",
"LabelerName": "Genus Lifesciences",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "meq/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150215",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55."
},
{
"NDCCode": "70461-322-03",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (70461-322-03) / .5 mL in 1 SYRINGE, GLASS (70461-322-04) ",
"NDC11Code": "70461-0322-03",
"ProductNDC": "70461-322",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flucelvax Quadrivalent",
"NonProprietaryName": "Influenza A Virus A/delaware/55/2019 Cvr-45 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/darwin/11/2021 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20220701",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125408",
"LabelerName": "Seqirus Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/DELAWARE/55/2019 CVR-45 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2023-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220701",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N"
},
{
"NDCCode": "84540-322-01",
"PackageDescription": "500 mg in 1 BLISTER PACK (84540-322-01) ",
"NDC11Code": "84540-0322-01",
"ProductNDC": "84540-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ki No Sin",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240829",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "NPG Bio Pharmaceuticals Co.,Ltd.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "55",
"StrengthUnit": "mg/500mg",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240829",
"SamplePackage": "N",
"IndicationAndUsage": "This health supplement can be used to aid in the improvement of body functions compromised by diabetes and kidney disease, and to help maintain normal calcium ion levels."
},
{
"NDCCode": "0069-3220-66",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0069-3220-66) ",
"NDC11Code": "00069-3220-66",
"ProductNDC": "0069-3220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feldene",
"NonProprietaryName": "Piroxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940525",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018147",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "PIROXICAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19940525",
"SamplePackage": "N",
"IndicationAndUsage": "FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch."
},
{
"NDCCode": "0069-3230-66",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0069-3230-66) ",
"NDC11Code": "00069-3230-66",
"ProductNDC": "0069-3230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Feldene",
"NonProprietaryName": "Piroxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19940525",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018147",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "PIROXICAM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19940525",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch."
},
{
"NDCCode": "0206-8860-02",
"PackageDescription": "24 BAG in 1 BOX (0206-8860-02) / 50 mL in 1 BAG (0206-8860-01) ",
"NDC11Code": "00206-8860-02",
"ProductNDC": "0206-8860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zosyn",
"ProprietaryNameSuffix": "In Galaxy Containers",
"NonProprietaryName": "Tazobactam Sodium And Piperacillin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050750",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": "250; 2",
"StrengthUnit": "mg/50mL; g/50mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980301",
"SamplePackage": "N",
"Description": "ZOSYN (piperacillin and tazobactam) Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. ZOSYN Injection in the GALAXY Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below. ZOSYN contains a total of 2.84 mEq (65 mg) of sodium (Na+) per gram of piperacillin in the combination product."
},
{
"NDCCode": "0206-8861-02",
"PackageDescription": "24 BAG in 1 BOX (0206-8861-02) / 50 mL in 1 BAG (0206-8861-01) ",
"NDC11Code": "00206-8861-02",
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"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
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"StrengthUnit": "mg/50mL; g/50mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
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"Description": "ZOSYN (piperacillin and tazobactam) Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. ZOSYN Injection in the GALAXY Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below. ZOSYN contains a total of 2.84 mEq (65 mg) of sodium (Na+) per gram of piperacillin in the combination product."
},
{
"NDCCode": "0206-8862-02",
"PackageDescription": "12 BAG in 1 BOX (0206-8862-02) / 100 mL in 1 BAG (0206-8862-01) ",
"NDC11Code": "00206-8862-02",
"ProductNDC": "0206-8862",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zosyn",
"ProprietaryNameSuffix": "In Galaxy Containers",
"NonProprietaryName": "Tazobactam Sodium And Piperacillin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050750",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": "500; 4",
"StrengthUnit": "mg/100mL; g/100mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
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"Description": "ZOSYN (piperacillin and tazobactam) Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. ZOSYN Injection in the GALAXY Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below. ZOSYN contains a total of 2.84 mEq (65 mg) of sodium (Na+) per gram of piperacillin in the combination product."
},
{
"NDCCode": "0264-3446-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3446-11) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3446-11",
"ProductNDC": "0264-3446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam And Sodium Chloride",
"NonProprietaryName": "Piperacillin And Tazobactam And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206056",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": "250; 2",
"StrengthUnit": "mg/50mL; g/50mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is supplied as a sterile powder for injection and a sterile solution in a single-dose DUPLEX® Container with a strength of 2.25 g, 3.375 g, or 4.5 g in the following presentations: 1 2.25 g: contains 2 grams of piperacillin (equivalent to 2.085 g of piperacillin sodium), 0.25 g of tazobactam (equivalent to 0.269 g of tazobactam sodium), 0.5 mg of edetate sodium dihydrate (EDTA), and 100 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 225 mg of sodium chloride and 50 mL of water for injection., 2 3.375 g: contains 3 grams of piperacillin (equivalent to 3.127 g of piperacillin sodium) and 0.375 g of tazobactam (equivalent to 0.402 g of tazobactam sodium), 0.75 mg of EDTA, and 150 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 150 mg of sodium chloride and 50 mL of water for injection., 3 4.5 g: contains 4 grams of piperacillin (equivalent to 4.170 g of piperacillin sodium), 0.5 g of tazobactam (equivalent to 0.538 g of tazobactam sodium), 1 mg of EDTA, and 200 mg of sodium citrate dihydrate. The diluent chamber contains 450 mg of sodium chloride and 100 mL of water for injection."
},
{
"NDCCode": "0264-3448-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3448-11) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3448-11",
"ProductNDC": "0264-3448",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam And Sodium Chloride",
"NonProprietaryName": "Piperacillin And Tazobactam And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206056",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": "375; 3",
"StrengthUnit": "mg/50mL; g/50mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is supplied as a sterile powder for injection and a sterile solution in a single-dose DUPLEX® Container with a strength of 2.25 g, 3.375 g, or 4.5 g in the following presentations: 1 2.25 g: contains 2 grams of piperacillin (equivalent to 2.085 g of piperacillin sodium), 0.25 g of tazobactam (equivalent to 0.269 g of tazobactam sodium), 0.5 mg of edetate sodium dihydrate (EDTA), and 100 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 225 mg of sodium chloride and 50 mL of water for injection., 2 3.375 g: contains 3 grams of piperacillin (equivalent to 3.127 g of piperacillin sodium) and 0.375 g of tazobactam (equivalent to 0.402 g of tazobactam sodium), 0.75 mg of EDTA, and 150 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 150 mg of sodium chloride and 50 mL of water for injection., 3 4.5 g: contains 4 grams of piperacillin (equivalent to 4.170 g of piperacillin sodium), 0.5 g of tazobactam (equivalent to 0.538 g of tazobactam sodium), 1 mg of EDTA, and 200 mg of sodium citrate dihydrate. The diluent chamber contains 450 mg of sodium chloride and 100 mL of water for injection."
}
]
}
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<ProprietaryName>Olanzapine</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078109</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2.</Description>
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<NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Oxybenzone</NonProprietaryName>
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<ApplicationNumber>part352</ApplicationNumber>
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<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
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<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
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<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC11Code>49884-0212-55</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
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<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone Orally Disintegrating Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCI. Risperidone Orally Disintegrating Tablets, USP are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths and are white in color. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: aspartame, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, mannitol, methacrylic acid polymer with divinylbenzene, modified food starch, silicon dioxide, sorbitol, talc, tartaric acid, and natural grapefruit flavor. This product meets USP Disintegration Test 2.</Description>
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<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone Orally Disintegrating Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCI. Risperidone Orally Disintegrating Tablets, USP are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths and are white in color. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: aspartame, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, mannitol, methacrylic acid polymer with divinylbenzene, modified food starch, silicon dioxide, sorbitol, talc, tartaric acid, and natural grapefruit flavor. This product meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
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<PackageDescription>5 BLISTER PACK in 1 CARTON (49884-315-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49884-0315-55</NDC11Code>
<ProductNDC>49884-315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077494</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone Orally Disintegrating Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCI. Risperidone Orally Disintegrating Tablets, USP are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths and are white in color. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: aspartame, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, mannitol, methacrylic acid polymer with divinylbenzene, modified food starch, silicon dioxide, sorbitol, talc, tartaric acid, and natural grapefruit flavor. This product meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>49884-320-55</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (49884-320-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-320-52) </PackageDescription>
<NDC11Code>49884-0320-55</NDC11Code>
<ProductNDC>49884-320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078109</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>49884-321-55</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (49884-321-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-321-52) </PackageDescription>
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<ProductNDC>49884-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078109</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (49884-323-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-323-52) </PackageDescription>
<NDC11Code>49884-0323-55</NDC11Code>
<ProductNDC>49884-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078109</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol, silicone dioxide, sorbitol, talc, and artificial pineapple flavor. Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>49884-459-55</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (49884-459-55) > 1 LOZENGE in 1 BLISTER PACK (49884-459-52)</PackageDescription>
<NDC11Code>49884-0459-55</NDC11Code>
<ProductNDC>49884-459</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077312</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-460-55</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (49884-460-55) > 1 LOZENGE in 1 BLISTER PACK (49884-460-52)</PackageDescription>
<NDC11Code>49884-0460-55</NDC11Code>
<ProductNDC>49884-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077312</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-461-55</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (49884-461-55) > 1 LOZENGE in 1 BLISTER PACK (49884-461-52)</PackageDescription>
<NDC11Code>49884-0461-55</NDC11Code>
<ProductNDC>49884-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077312</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-462-55</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (49884-462-55) > 1 LOZENGE in 1 BLISTER PACK (49884-462-52)</PackageDescription>
<NDC11Code>49884-0462-55</NDC11Code>
<ProductNDC>49884-462</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077312</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-463-55</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (49884-463-55) > 1 LOZENGE in 1 BLISTER PACK (49884-463-52)</PackageDescription>
<NDC11Code>49884-0463-55</NDC11Code>
<ProductNDC>49884-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077312</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-464-55</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (49884-464-55) > 1 LOZENGE in 1 BLISTER PACK (49884-464-52)</PackageDescription>
<NDC11Code>49884-0464-55</NDC11Code>
<ProductNDC>49884-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077312</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (49884-701-55) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49884-0701-55</NDC11Code>
<ProductNDC>49884-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomiphene Citrate</ProprietaryName>
<NonProprietaryName>Clomiphene Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990830</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075528</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>CLOMIPHENE CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990920</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.). Clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below. 1. Patients who are not pregnant.2. Patients without ovarian cysts. Clomiphene citrate should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate treatment.3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present.4. Patients with normal liver function. In addition, patients selected for clomiphene citrate therapy should be evaluated in regard to the following. 1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy.2. Primary Pituitary or Ovarian Failure. Clomiphene citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure.3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to clomiphene citrate therapy in this population.4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility.5. Uterine Fibroids. Caution should be exercised when using clomiphene citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene citrate is not known. Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation-inducing drugs). Similarly, there is no standard clomiphene citrate regimen for ovulation induction in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate is not recommended for these uses.</IndicationAndUsage>
<Description>Clomiphene Citrate Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C26H28CINO C6H8O7 and a molecular weight of 598.10. It is represented structurally as. Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white debossed tablet contains 50 mg clomiphene citrate USP. The tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>49884-903-55</NDCCode>
<PackageDescription>30 TABLET in 1 CARTON (49884-903-55) </PackageDescription>
<NDC11Code>49884-0903-55</NDC11Code>
<ProductNDC>49884-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20161104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201509</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14)]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem tartrate sublingual tablets contains zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate sublingual tablets are available in 5 mg and 10 mg strength tablets for sublingual administration. Chemically, zolpidem tartrate, USP is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white or almost white, crystalline, hygroscopic powder that is slightly soluble in water, sparingly soluble in methanol, and practically insoluble in methylene chloride. It has a molecular weight of 764.87. Each zolpidem tartrate sublingual tablet includes the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch and saccharin sodium.</Description>
</NDC>
<NDC>
<NDCCode>49884-904-55</NDCCode>
<PackageDescription>30 TABLET in 1 CARTON (49884-904-55) </PackageDescription>
<NDC11Code>49884-0904-55</NDC11Code>
<ProductNDC>49884-904</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20161104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201509</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14)]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem tartrate sublingual tablets contains zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate sublingual tablets are available in 5 mg and 10 mg strength tablets for sublingual administration. Chemically, zolpidem tartrate, USP is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white or almost white, crystalline, hygroscopic powder that is slightly soluble in water, sparingly soluble in methanol, and practically insoluble in methylene chloride. It has a molecular weight of 764.87. Each zolpidem tartrate sublingual tablet includes the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch and saccharin sodium.</Description>
</NDC>
<NDC>
<NDCCode>27808-322-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27808-322-01) </PackageDescription>
<NDC11Code>27808-0322-01</NDC11Code>
<ProductNDC>27808-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219073</ApplicationNumber>
<LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is (+)-5-[2-(Dimethylamino)ethyl]-cis-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one acetate (ester) monohydrochloride. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride, USP (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride, USP (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem). Inactive ingredients: gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer, povidone, red iron oxide, silicon dioxide, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>64950-322-47</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (64950-322-47) </PackageDescription>
<NDC11Code>64950-0322-47</NDC11Code>
<ProductNDC>64950-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206814</ApplicationNumber>
<LabelerName>Genus Lifesciences</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>meq/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55.</Description>
</NDC>
<NDC>
<NDCCode>70461-322-03</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (70461-322-03) / .5 mL in 1 SYRINGE, GLASS (70461-322-04) </PackageDescription>
<NDC11Code>70461-0322-03</NDC11Code>
<ProductNDC>70461-322</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flucelvax Quadrivalent</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/delaware/55/2019 Cvr-45 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/darwin/11/2021 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<EndMarketingDate>20230731</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125408</ApplicationNumber>
<LabelerName>Seqirus Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/DELAWARE/55/2019 CVR-45 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220701</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84540-322-01</NDCCode>
<PackageDescription>500 mg in 1 BLISTER PACK (84540-322-01) </PackageDescription>
<NDC11Code>84540-0322-01</NDC11Code>
<ProductNDC>84540-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ki No Sin</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>NPG Bio Pharmaceuticals Co.,Ltd.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>55</StrengthNumber>
<StrengthUnit>mg/500mg</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This health supplement can be used to aid in the improvement of body functions compromised by diabetes and kidney disease, and to help maintain normal calcium ion levels.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-3220-66</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0069-3220-66) </PackageDescription>
<NDC11Code>00069-3220-66</NDC11Code>
<ProductNDC>0069-3220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feldene</ProprietaryName>
<NonProprietaryName>Piroxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940525</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018147</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>PIROXICAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.</Description>
</NDC>
<NDC>
<NDCCode>0069-3230-66</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0069-3230-66) </PackageDescription>
<NDC11Code>00069-3230-66</NDC11Code>
<ProductNDC>0069-3230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Feldene</ProprietaryName>
<NonProprietaryName>Piroxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940525</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018147</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>PIROXICAM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19940525</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FELDENE is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.</Description>
</NDC>
<NDC>
<NDCCode>0206-8860-02</NDCCode>
<PackageDescription>24 BAG in 1 BOX (0206-8860-02) / 50 mL in 1 BAG (0206-8860-01) </PackageDescription>
<NDC11Code>00206-8860-02</NDC11Code>
<ProductNDC>0206-8860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zosyn</ProprietaryName>
<ProprietaryNameSuffix>In Galaxy Containers</ProprietaryNameSuffix>
<NonProprietaryName>Tazobactam Sodium And Piperacillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050750</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>250; 2</StrengthNumber>
<StrengthUnit>mg/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ZOSYN (piperacillin and tazobactam) Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. ZOSYN Injection in the GALAXY Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below. ZOSYN contains a total of 2.84 mEq (65 mg) of sodium (Na+) per gram of piperacillin in the combination product.</Description>
</NDC>
<NDC>
<NDCCode>0206-8861-02</NDCCode>
<PackageDescription>24 BAG in 1 BOX (0206-8861-02) / 50 mL in 1 BAG (0206-8861-01) </PackageDescription>
<NDC11Code>00206-8861-02</NDC11Code>
<ProductNDC>0206-8861</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zosyn</ProprietaryName>
<ProprietaryNameSuffix>In Galaxy Containers</ProprietaryNameSuffix>
<NonProprietaryName>Tazobactam Sodium And Piperacillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050750</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>375; 3</StrengthNumber>
<StrengthUnit>mg/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ZOSYN (piperacillin and tazobactam) Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. ZOSYN Injection in the GALAXY Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below. ZOSYN contains a total of 2.84 mEq (65 mg) of sodium (Na+) per gram of piperacillin in the combination product.</Description>
</NDC>
<NDC>
<NDCCode>0206-8862-02</NDCCode>
<PackageDescription>12 BAG in 1 BOX (0206-8862-02) / 100 mL in 1 BAG (0206-8862-01) </PackageDescription>
<NDC11Code>00206-8862-02</NDC11Code>
<ProductNDC>0206-8862</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zosyn</ProprietaryName>
<ProprietaryNameSuffix>In Galaxy Containers</ProprietaryNameSuffix>
<NonProprietaryName>Tazobactam Sodium And Piperacillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050750</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>500; 4</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ZOSYN (piperacillin and tazobactam) Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. ZOSYN Injection in the GALAXY Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below. ZOSYN contains a total of 2.84 mEq (65 mg) of sodium (Na+) per gram of piperacillin in the combination product.</Description>
</NDC>
<NDC>
<NDCCode>0264-3446-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3446-11) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3446-11</NDC11Code>
<ProductNDC>0264-3446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206056</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>250; 2</StrengthNumber>
<StrengthUnit>mg/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is supplied as a sterile powder for injection and a sterile solution in a single-dose DUPLEX® Container with a strength of 2.25 g, 3.375 g, or 4.5 g in the following presentations: 1 2.25 g: contains 2 grams of piperacillin (equivalent to 2.085 g of piperacillin sodium), 0.25 g of tazobactam (equivalent to 0.269 g of tazobactam sodium), 0.5 mg of edetate sodium dihydrate (EDTA), and 100 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 225 mg of sodium chloride and 50 mL of water for injection., 2 3.375 g: contains 3 grams of piperacillin (equivalent to 3.127 g of piperacillin sodium) and 0.375 g of tazobactam (equivalent to 0.402 g of tazobactam sodium), 0.75 mg of EDTA, and 150 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 150 mg of sodium chloride and 50 mL of water for injection., 3 4.5 g: contains 4 grams of piperacillin (equivalent to 4.170 g of piperacillin sodium), 0.5 g of tazobactam (equivalent to 0.538 g of tazobactam sodium), 1 mg of EDTA, and 200 mg of sodium citrate dihydrate. The diluent chamber contains 450 mg of sodium chloride and 100 mL of water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0264-3448-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3448-11) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3448-11</NDC11Code>
<ProductNDC>0264-3448</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206056</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>375; 3</StrengthNumber>
<StrengthUnit>mg/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is supplied as a sterile powder for injection and a sterile solution in a single-dose DUPLEX® Container with a strength of 2.25 g, 3.375 g, or 4.5 g in the following presentations: 1 2.25 g: contains 2 grams of piperacillin (equivalent to 2.085 g of piperacillin sodium), 0.25 g of tazobactam (equivalent to 0.269 g of tazobactam sodium), 0.5 mg of edetate sodium dihydrate (EDTA), and 100 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 225 mg of sodium chloride and 50 mL of water for injection., 2 3.375 g: contains 3 grams of piperacillin (equivalent to 3.127 g of piperacillin sodium) and 0.375 g of tazobactam (equivalent to 0.402 g of tazobactam sodium), 0.75 mg of EDTA, and 150 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 150 mg of sodium chloride and 50 mL of water for injection., 3 4.5 g: contains 4 grams of piperacillin (equivalent to 4.170 g of piperacillin sodium), 0.5 g of tazobactam (equivalent to 0.538 g of tazobactam sodium), 1 mg of EDTA, and 200 mg of sodium citrate dihydrate. The diluent chamber contains 450 mg of sodium chloride and 100 mL of water for injection.</Description>
</NDC>
</NDCList>