{
"NDC": [
{
"NDCCode": "61874-145-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-145-07) ",
"NDC11Code": "61874-0145-07",
"ProductNDC": "61874-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-115-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) ",
"NDC11Code": "61874-0115-07",
"ProductNDC": "61874-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-130-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-130-07) ",
"NDC11Code": "61874-0130-07",
"ProductNDC": "61874-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-160-07",
"PackageDescription": "7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-160-07) ",
"NDC11Code": "61874-0160-07",
"ProductNDC": "61874-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "Y",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-145-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-145-30) ",
"NDC11Code": "61874-0145-30",
"ProductNDC": "61874-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].",
"Description": "The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg)."
},
{
"NDCCode": "61874-145-63",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (61874-145-63) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-145-11)",
"NDC11Code": "61874-0145-63",
"ProductNDC": "61874-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "61874-145-90",
"PackageDescription": "90 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-145-90) ",
"NDC11Code": "61874-0145-90",
"ProductNDC": "61874-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vraylar",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204370",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N"
},
{
"NDCCode": "57344-145-07",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-145-07)",
"NDC11Code": "57344-0145-07",
"ProductNDC": "57344-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079096",
"LabelerName": "AAA Pharmaceutical, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-13",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "61786-145-07",
"PackageDescription": "12 TABLET in 1 BLISTER PACK (61786-145-07)",
"NDC11Code": "61786-0145-07",
"ProductNDC": "61786-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078888",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-03-10"
},
{
"NDCCode": "63323-145-07",
"PackageDescription": "1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL",
"NDC11Code": "63323-0145-07",
"ProductNDC": "63323-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Floxuridine",
"NonProprietaryName": "Floxuridine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRA-ARTERIAL",
"StartMarketingDate": "20010315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075837",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "FLOXURIDINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antimetabolite [EPC], Deoxyuridine [CS]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010315",
"SamplePackage": "N",
"IndicationAndUsage": "Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.",
"Description": "Floxuridine for Injection, USP, an antineoplastic antimetabolite, is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. Each vial contains 500 mg of floxuridine which is to be reconstituted with 5 mL of sterile water for injection. An appropriate amount of reconstituted solution is then diluted with a parenteral solution for intra-arterial infusion (see DOSAGE AND ADMINISTRATION). Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is 2’-deoxy-5-fluorouridine. It is a white to off-white odorless solid which is freely soluble in water. The 2% aqueous solution has a pH of between 4.0 and 5.5. The structural formula is."
},
{
"NDCCode": "64220-145-07",
"PackageDescription": "20 kg in 1 DRUM (64220-145-07)",
"NDC11Code": "64220-0145-07",
"ProductNDC": "64220-145",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20051201",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2020-03-07",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "67046-145-07",
"PackageDescription": "7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-145-07)",
"NDC11Code": "67046-0145-07",
"ProductNDC": "67046-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078597",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .",
"Description": "Divalproex sodium is a stable coordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure: Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets: colloidal silicon dioxide, corn starch, povidone, pregelatinized maize starch, hypromellose, titanium dioxide, triacetin, methacrylic acid copolymer type C, talc, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, and sodium lauryl sulfate. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. In addition, individual tablets contain. 125 mg tablets: FD&C Red #40, and FD&C Blue #2. 250 mg tablets: FD&C Yellow #6, and iron oxide yellow. 500 mg tablets: D&C Red #30, FD&C Blue #2, and iron oxide red."
},
{
"NDCCode": "71919-145-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-145-07) ",
"NDC11Code": "71919-0145-07",
"ProductNDC": "71919-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Caustica",
"NonProprietaryName": "Calcium Hydroxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100729",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM HYDROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100729",
"SamplePackage": "N"
},
{
"NDCCode": "73377-145-07",
"PackageDescription": "980 g in 1 JAR (73377-145-07) ",
"NDC11Code": "73377-0145-07",
"ProductNDC": "73377-145",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210820",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "25-AUG-25"
},
{
"NDCCode": "83589-145-07",
"PackageDescription": "50 g in 1 BAG (83589-145-07) ",
"NDC11Code": "83589-0145-07",
"ProductNDC": "83589-145",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Peg-mgf Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260225",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "MECHANO GROWTH FACTOR",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "25-FEB-26"
},
{
"NDCCode": "0378-3066-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-93)",
"NDC11Code": "00378-3066-93",
"ProductNDC": "0378-3066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202856",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-09-07"
},
{
"NDCCode": "0456-1201-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1201-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1201-07",
"ProductNDC": "0456-1201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "145",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190517",
"SamplePackage": "Y",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1202-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1202-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1202-07",
"ProductNDC": "0456-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "290",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190517",
"SamplePackage": "Y",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1203-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1203-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1203-07",
"ProductNDC": "0456-1203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "72",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190517",
"SamplePackage": "Y",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0904-7161-04",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0904-7161-04) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7161-04",
"ProductNDC": "0904-7161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208709",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161215",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets are indicated as adjunctive therapy to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)., 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.",
"Description": "Fenofibrate, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum."
},
{
"NDCCode": "0904-7480-04",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0904-7480-04) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7480-04",
"ProductNDC": "0904-7480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090856",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250219",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets USP is indicated as adjunctive therapy to diet: 1 To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). , 2 To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.",
"Description": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, lactose monohydrate, polacrillin potassium, sodium lauryl sulphate, and sucrose."
},
{
"NDCCode": "0904-7480-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7480-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7480-61",
"ProductNDC": "0904-7480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090856",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250219",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets USP is indicated as adjunctive therapy to diet: 1 To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). , 2 To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.",
"Description": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, lactose monohydrate, polacrillin potassium, sodium lauryl sulphate, and sucrose."
},
{
"NDCCode": "12745-145-01",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (12745-145-01) ",
"NDC11Code": "12745-0145-01",
"ProductNDC": "12745-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bak",
"ProprietaryNameSuffix": "1 750",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19540615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Medical Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1713",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19540615",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions."
},
{
"NDCCode": "12745-145-02",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (12745-145-02) ",
"NDC11Code": "12745-0145-02",
"ProductNDC": "12745-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bak",
"ProprietaryNameSuffix": "1 750",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19540615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Medical Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1713",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19540615",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions."
},
{
"NDCCode": "13533-613-20",
"PackageDescription": "1 VIAL in 1 CARTON (13533-613-20) > 50 mL in 1 VIAL (13533-613-21) ",
"NDC11Code": "13533-0613-20",
"ProductNDC": "13533-613",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Plasmanate",
"NonProprietaryName": "Plasma Protein Fraction (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19581002",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101140",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "2.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19581002",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.",
"Description": "This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.(1) The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate is clear and amber colored. Plasmanate must be administered intravenously. This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. (5-8) The production steps from Pooled Plasma to Effluent IV-1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "13533-613-25",
"PackageDescription": "1 VIAL in 1 CARTON (13533-613-25) / 250 mL in 1 VIAL (13533-613-26) ",
"NDC11Code": "13533-0613-25",
"ProductNDC": "13533-613",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Plasmanate",
"NonProprietaryName": "Plasma Protein Fraction (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19581002",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101140",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "2.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19581002",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.",
"Description": "This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.(1) The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate is clear and amber colored. Plasmanate must be administered intravenously. This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. (5-8) The production steps from Pooled Plasma to Effluent IV-1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "13533-613-27",
"PackageDescription": "1 VIAL in 1 CARTON (13533-613-27) > 500 mL in 1 VIAL (13533-613-28) ",
"NDC11Code": "13533-0613-27",
"ProductNDC": "13533-613",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Plasmanate",
"NonProprietaryName": "Plasma Protein Fraction (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19581002",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101140",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
"StrengthNumber": "2.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19581002",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.",
"Description": "This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.(1) The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate is clear and amber colored. Plasmanate must be administered intravenously. This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. (5-8) The production steps from Pooled Plasma to Effluent IV-1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "13533-690-20",
"PackageDescription": "1 VIAL in 1 CARTON (13533-690-20) > 50 mL in 1 VIAL (13533-690-21) ",
"NDC11Code": "13533-0690-20",
"ProductNDC": "13533-690",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Plasbumin",
"NonProprietaryName": "Albumin (human)",
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<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>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VRAYLAR® is indicated for. Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)]. Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)]. Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains 0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>61874-145-63</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (61874-145-63) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-145-11)</PackageDescription>
<NDC11Code>61874-0145-63</NDC11Code>
<ProductNDC>61874-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>61874-145-90</NDCCode>
<PackageDescription>90 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-145-90) </PackageDescription>
<NDC11Code>61874-0145-90</NDC11Code>
<ProductNDC>61874-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vraylar</ProprietaryName>
<NonProprietaryName>Cariprazine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150917</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204370</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CARIPRAZINE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57344-145-07</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-145-07)</PackageDescription>
<NDC11Code>57344-0145-07</NDC11Code>
<ProductNDC>57344-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079096</ApplicationNumber>
<LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-13</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61786-145-07</NDCCode>
<PackageDescription>12 TABLET in 1 BLISTER PACK (61786-145-07)</PackageDescription>
<NDC11Code>61786-0145-07</NDC11Code>
<ProductNDC>61786-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078888</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-03-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>63323-145-07</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0145-07</NDC11Code>
<ProductNDC>63323-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Floxuridine</ProprietaryName>
<NonProprietaryName>Floxuridine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL</RouteName>
<StartMarketingDate>20010315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075837</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>FLOXURIDINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antimetabolite [EPC], Deoxyuridine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.</IndicationAndUsage>
<Description>Floxuridine for Injection, USP, an antineoplastic antimetabolite, is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. Each vial contains 500 mg of floxuridine which is to be reconstituted with 5 mL of sterile water for injection. An appropriate amount of reconstituted solution is then diluted with a parenteral solution for intra-arterial infusion (see DOSAGE AND ADMINISTRATION). Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is 2’-deoxy-5-fluorouridine. It is a white to off-white odorless solid which is freely soluble in water. The 2% aqueous solution has a pH of between 4.0 and 5.5. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>64220-145-07</NDCCode>
<PackageDescription>20 kg in 1 DRUM (64220-145-07)</PackageDescription>
<NDC11Code>64220-0145-07</NDC11Code>
<ProductNDC>64220-145</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20051201</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-03-07</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67046-145-07</NDCCode>
<PackageDescription>7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-145-07)</PackageDescription>
<NDC11Code>67046-0145-07</NDC11Code>
<ProductNDC>67046-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078597</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .</IndicationAndUsage>
<Description>Divalproex sodium is a stable coordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure: Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets: colloidal silicon dioxide, corn starch, povidone, pregelatinized maize starch, hypromellose, titanium dioxide, triacetin, methacrylic acid copolymer type C, talc, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, and sodium lauryl sulfate. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. In addition, individual tablets contain. 125 mg tablets: FD&C Red #40, and FD&C Blue #2. 250 mg tablets: FD&C Yellow #6, and iron oxide yellow. 500 mg tablets: D&C Red #30, FD&C Blue #2, and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>71919-145-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-145-07) </PackageDescription>
<NDC11Code>71919-0145-07</NDC11Code>
<ProductNDC>71919-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Caustica</ProprietaryName>
<NonProprietaryName>Calcium Hydroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100729</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM HYDROXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73377-145-07</NDCCode>
<PackageDescription>980 g in 1 JAR (73377-145-07) </PackageDescription>
<NDC11Code>73377-0145-07</NDC11Code>
<ProductNDC>73377-145</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210820</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-AUG-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>83589-145-07</NDCCode>
<PackageDescription>50 g in 1 BAG (83589-145-07) </PackageDescription>
<NDC11Code>83589-0145-07</NDC11Code>
<ProductNDC>83589-145</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Peg-mgf Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260225</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>MECHANO GROWTH FACTOR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-FEB-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0378-3066-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-93)</PackageDescription>
<NDC11Code>00378-3066-93</NDC11Code>
<ProductNDC>0378-3066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202856</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-1201-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1201-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1201-07</NDC11Code>
<ProductNDC>0456-1201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190517</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1202-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1202-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1202-07</NDC11Code>
<ProductNDC>0456-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>290</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190517</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1203-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1203-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1203-07</NDC11Code>
<ProductNDC>0456-1203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190517</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0904-7161-04</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (0904-7161-04) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7161-04</NDC11Code>
<ProductNDC>0904-7161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208709</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate tablets are indicated as adjunctive therapy to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)., 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.</IndicationAndUsage>
<Description>Fenofibrate, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0904-7480-04</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (0904-7480-04) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7480-04</NDC11Code>
<ProductNDC>0904-7480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090856</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate tablets USP is indicated as adjunctive therapy to diet: 1 To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). , 2 To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.</IndicationAndUsage>
<Description>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, lactose monohydrate, polacrillin potassium, sodium lauryl sulphate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>0904-7480-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7480-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7480-61</NDC11Code>
<ProductNDC>0904-7480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090856</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate tablets USP is indicated as adjunctive therapy to diet: 1 To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). , 2 To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.</IndicationAndUsage>
<Description>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, lactose monohydrate, polacrillin potassium, sodium lauryl sulphate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>12745-145-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (12745-145-01) </PackageDescription>
<NDC11Code>12745-0145-01</NDC11Code>
<ProductNDC>12745-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bak</ProprietaryName>
<ProprietaryNameSuffix>1 750</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19540615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Medical Chemical Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1713</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19540615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12745-145-02</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (12745-145-02) </PackageDescription>
<NDC11Code>12745-0145-02</NDC11Code>
<ProductNDC>12745-145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bak</ProprietaryName>
<ProprietaryNameSuffix>1 750</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19540615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Medical Chemical Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1713</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19540615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13533-613-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-613-20) > 50 mL in 1 VIAL (13533-613-21) </PackageDescription>
<NDC11Code>13533-0613-20</NDC11Code>
<ProductNDC>13533-613</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasmanate</ProprietaryName>
<NonProprietaryName>Plasma Protein Fraction (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19581002</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101140</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19581002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.</IndicationAndUsage>
<Description>This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.(1) The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate is clear and amber colored. Plasmanate must be administered intravenously. This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. (5-8) The production steps from Pooled Plasma to Effluent IV-1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>13533-613-25</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-613-25) / 250 mL in 1 VIAL (13533-613-26) </PackageDescription>
<NDC11Code>13533-0613-25</NDC11Code>
<ProductNDC>13533-613</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasmanate</ProprietaryName>
<NonProprietaryName>Plasma Protein Fraction (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19581002</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101140</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19581002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.</IndicationAndUsage>
<Description>This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.(1) The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate is clear and amber colored. Plasmanate must be administered intravenously. This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. (5-8) The production steps from Pooled Plasma to Effluent IV-1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>13533-613-27</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-613-27) > 500 mL in 1 VIAL (13533-613-28) </PackageDescription>
<NDC11Code>13533-0613-27</NDC11Code>
<ProductNDC>13533-613</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasmanate</ProprietaryName>
<NonProprietaryName>Plasma Protein Fraction (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19581002</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101140</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19581002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.</IndicationAndUsage>
<Description>This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate® contains 5 g selected plasma proteins buffered with sodium carbonate and stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The plasma proteins consist of approximately 88% normal human albumin, 12% alpha and beta globulins and not more than 1% gamma globulin as determined by electrophoresis.(1) The concentration of these proteins is such that this solution is iso-oncotic with normal human plasma and is isotonic. The approximate concentrations of the significant electrolytes in Plasmanate are: sodium 145 mEq/L, potassium 0.25 mEq/L, and chloride 100 mEq/L. Plasmanate is clear and amber colored. Plasmanate must be administered intravenously. This product is designed to bring to the medical profession a preparation derived from human blood and similar to human plasma. Each vial of Plasmanate is sterile and heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. The blood group agglutinins and agglutinogens A and B are at such a low level in Plasmanate solution that its use has no effect on routine blood typing procedures. No chemical or microscopic alterations of the urine have been observed with its use. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. (5-8) The production steps from Pooled Plasma to Effluent IV-1 in the Plasmanate manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>13533-690-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-690-20) > 50 mL in 1 VIAL (13533-690-21) </PackageDescription>
<NDC11Code>13533-0690-20</NDC11Code>
<ProductNDC>13533-690</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19940926</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Emergency Treatment of Hypovolemic Shock. Plasbumin-5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Plasbumin-5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Plasbumin®-25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Plasbumin-25 is used, appropriate additional crystalloid should be administered.(1). Crystalloid solutions in volumes several times greater than that of Plasbumin-5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be instituted, may not tolerate hypoalbuminemia as well.(1). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of albumin infusion may be required to support the blood volume.(1). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin can be used to maintain plasma colloid osmotic pressure. Plasbumin-25 may be preferred for this purpose.(1). Cardiopulmonary Bypass(1). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure(1). In the uncommon situation of rapid loss of liver function, with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Sequestration of Protein Rich Fluids(2). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Situations in Which Albumin Administration is Not Warranted(1). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.</IndicationAndUsage>
<Description>Albumin (Human) 5%, USP (Plasbumin®-5) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Plasbumin-5 is a 5% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Plasbumin-5 is clear, slightly viscous, almost colorless to yellow, amber or green. It contains no preservative. Plasbumin-5 must be administered intravenously. Each vial of Plasbumin-5 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(8-11) The production steps from Pooled Plasma to Effluent IV-1 in the Plasbumin-5 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>13533-690-25</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-690-25) > 250 mL in 1 VIAL (13533-690-26) </PackageDescription>
<NDC11Code>13533-0690-25</NDC11Code>
<ProductNDC>13533-690</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19940926</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Emergency Treatment of Hypovolemic Shock. Plasbumin-5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Plasbumin-5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Plasbumin®-25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Plasbumin-25 is used, appropriate additional crystalloid should be administered.(1). Crystalloid solutions in volumes several times greater than that of Plasbumin-5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be instituted, may not tolerate hypoalbuminemia as well.(1). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of albumin infusion may be required to support the blood volume.(1). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin can be used to maintain plasma colloid osmotic pressure. Plasbumin-25 may be preferred for this purpose.(1). Cardiopulmonary Bypass(1). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure(1). In the uncommon situation of rapid loss of liver function, with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Sequestration of Protein Rich Fluids(2). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Situations in Which Albumin Administration is Not Warranted(1). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.</IndicationAndUsage>
<Description>Albumin (Human) 5%, USP (Plasbumin®-5) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Plasbumin-5 is a 5% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Plasbumin-5 is clear, slightly viscous, almost colorless to yellow, amber or green. It contains no preservative. Plasbumin-5 must be administered intravenously. Each vial of Plasbumin-5 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(8-11) The production steps from Pooled Plasma to Effluent IV-1 in the Plasbumin-5 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>13533-690-27</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-690-27) > 500 mL in 1 VIAL (13533-690-28) </PackageDescription>
<NDC11Code>13533-0690-27</NDC11Code>
<ProductNDC>13533-690</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19940926</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Emergency Treatment of Hypovolemic Shock. Plasbumin-5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Plasbumin-5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Plasbumin®-25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Plasbumin-25 is used, appropriate additional crystalloid should be administered.(1). Crystalloid solutions in volumes several times greater than that of Plasbumin-5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be instituted, may not tolerate hypoalbuminemia as well.(1). Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of albumin infusion may be required to support the blood volume.(1). Burn Therapy. An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin can be used to maintain plasma colloid osmotic pressure. Plasbumin-25 may be preferred for this purpose.(1). Cardiopulmonary Bypass(1). With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient. Acute Liver Failure(1). In the uncommon situation of rapid loss of liver function, with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin. Sequestration of Protein Rich Fluids(2). This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin. Situations in Which Albumin Administration is Not Warranted(1). In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid “priming” diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.</IndicationAndUsage>
<Description>Albumin (Human) 5%, USP (Plasbumin®-5) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Plasbumin-5 is a 5% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Plasbumin-5 is clear, slightly viscous, almost colorless to yellow, amber or green. It contains no preservative. Plasbumin-5 must be administered intravenously. Each vial of Plasbumin-5 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(8-11) The production steps from Pooled Plasma to Effluent IV-1 in the Plasbumin-5 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
</NDCList>