{
"NDC": [
{
"NDCCode": "12496-1100-1",
"PackageDescription": "130 kg in 1 DRUM (12496-1100-1)",
"NDC11Code": "12496-1100-01",
"ProductNDC": "12496-1100",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20021020",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indivior Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "12496-0003-2",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "12496-0003-02",
"ProductNDC": "12496-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opvee",
"NonProprietaryName": "Nalmefene Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20231002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217470",
"LabelerName": "Indivior Inc.",
"SubstanceName": "NALMEFENE HYDROCHLORIDE",
"StrengthNumber": "2.7",
"StrengthUnit": "mg/100uL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "N",
"IndicationAndUsage": "OPVEE nasal spray is indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. OPVEE nasal spray is not a substitute for emergency medical care.",
"Description": "OPVEE (nalmefene) nasal spray is a pre-filled, unit-dose intranasal spray. Nalmefene, an opioid antagonist, is a 6-methylene analogue of naltrexone. The molecular structure of nalmefene is presented below. Molecular Formula: C 21H 25NO 3∙HCl. Molecular Weight: 375.9, CAS # 58895-64-0. Chemical Name: 17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt. Nalmefene is a white to off-white crystalline powder which is freely soluble in methanol and water, with a pK of 7.63. Each OPVEE nasal spray unit delivers 2.7 mg nalmefene (equivalent to 3mg nalmefene hydrochloride) in 0.1 mL solution. Inactive ingredients include benzalkonium chloride, disodium ethylenediaminetetraacetate, dodecylmaltoside, sodium chloride, and purified water. The pH range is 4.1 to 4.9."
},
{
"NDCCode": "12496-0090-1",
"PackageDescription": "1 KIT in 1 CARTON (12496-0090-1) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5) ",
"NDC11Code": "12496-0090-01",
"ProductNDC": "12496-0090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perseris",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210655",
"LabelerName": "Indivior Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181109",
"SamplePackage": "N",
"IndicationAndUsage": "PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .",
"Description": "PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6)."
},
{
"NDCCode": "12496-0090-9",
"PackageDescription": "1 KIT in 1 CARTON (12496-0090-9) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5) ",
"NDC11Code": "12496-0090-09",
"ProductNDC": "12496-0090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perseris",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210655",
"LabelerName": "Indivior Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190212",
"SamplePackage": "Y",
"IndicationAndUsage": "PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .",
"Description": "PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6)."
},
{
"NDCCode": "12496-0100-1",
"PackageDescription": "1 POUCH in 1 CARTON (12496-0100-1) / 1 SYRINGE in 1 POUCH (12496-0100-2) / 1 SOLUTION in 1 SYRINGE (12496-0100-5) ",
"NDC11Code": "12496-0100-01",
"ProductNDC": "12496-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sublocade",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209819",
"LabelerName": "Indivior Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180226",
"SamplePackage": "N",
"IndicationAndUsage": "SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBLOCADE (buprenorphine extended-release) injection is a clear, viscous, colorless to yellow to amber, sterile solution for subcutaneous injection only. It is designed to deliver buprenorphine at a controlled rate over a one month period. The active ingredient in SUBLOCADE is buprenorphine free base, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist. Buprenorphine is dissolved in the ATRIGEL ®delivery system at 18% by weight. The ATRIGEL ®delivery system is a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). SUBLOCADE is provided in dosage strengths of 100 mg and 300 mg. Table 6presents the delivered amounts of the raw materials and the approximate delivered volume for the two dosage strengths. The molecular weight of buprenorphine free base is 467.6, and its molecular formula is C 29H 41NO 4. Chemically, buprenorphine is (2S)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol. The structural formula is:."
},
{
"NDCCode": "12496-0120-1",
"PackageDescription": "1 KIT in 1 CARTON (12496-0120-1) * 1 SYRINGE in 1 POUCH (12496-0120-2) / 1.2 mL in 1 SYRINGE (12496-0120-5) * 1 SYRINGE in 1 POUCH (12496-0776-2) / 1 mL in 1 SYRINGE (12496-0776-5) ",
"NDC11Code": "12496-0120-01",
"ProductNDC": "12496-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perseris",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210655",
"LabelerName": "Indivior Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181109",
"SamplePackage": "N",
"IndicationAndUsage": "PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .",
"Description": "PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6)."
},
{
"NDCCode": "12496-0120-9",
"PackageDescription": "1 KIT in 1 CARTON (12496-0120-9) * 1 SYRINGE in 1 POUCH (12496-0120-2) / 1.2 mL in 1 SYRINGE (12496-0120-5) * 1 SYRINGE in 1 POUCH (12496-0776-2) / 1 mL in 1 SYRINGE (12496-0776-5) ",
"NDC11Code": "12496-0120-09",
"ProductNDC": "12496-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perseris",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210655",
"LabelerName": "Indivior Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190212",
"SamplePackage": "Y",
"IndicationAndUsage": "PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .",
"Description": "PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6)."
},
{
"NDCCode": "12496-0300-1",
"PackageDescription": "1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5) ",
"NDC11Code": "12496-0300-01",
"ProductNDC": "12496-0300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sublocade",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209819",
"LabelerName": "Indivior Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180226",
"SamplePackage": "N",
"IndicationAndUsage": "SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBLOCADE (buprenorphine extended-release) injection is a clear, viscous, colorless to yellow to amber, sterile solution for subcutaneous injection only. It is designed to deliver buprenorphine at a controlled rate over a one month period. The active ingredient in SUBLOCADE is buprenorphine free base, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist. Buprenorphine is dissolved in the ATRIGEL ®delivery system at 18% by weight. The ATRIGEL ®delivery system is a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). SUBLOCADE is provided in dosage strengths of 100 mg and 300 mg. Table 6presents the delivered amounts of the raw materials and the approximate delivered volume for the two dosage strengths. The molecular weight of buprenorphine free base is 467.6, and its molecular formula is C 29H 41NO 4. Chemically, buprenorphine is (2S)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol. The structural formula is:."
},
{
"NDCCode": "12496-0757-1",
"PackageDescription": "5 AMPULE in 1 CARTON (12496-0757-1) > 1 mL in 1 AMPULE",
"NDC11Code": "12496-0757-01",
"ProductNDC": "12496-0757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenex",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19850630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018401",
"LabelerName": "Reckitt Benckiser Pharmaceuticals Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "12496-0757-5",
"PackageDescription": "5 AMPULE in 1 CARTON (12496-0757-5) / 1 mL in 1 AMPULE (12496-0757-1) ",
"NDC11Code": "12496-0757-05",
"ProductNDC": "12496-0757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenex",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19850630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018401",
"LabelerName": "Indivior Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19850630",
"SamplePackage": "N"
},
{
"NDCCode": "12496-1202-3",
"PackageDescription": "30 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) ",
"NDC11Code": "12496-1202-03",
"ProductNDC": "12496-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022410",
"LabelerName": "INDIVIOR INC.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "2; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100913",
"SamplePackage": "N",
"IndicationAndUsage": "SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "12496-1204-3",
"PackageDescription": "30 POUCH in 1 CARTON (12496-1204-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1) ",
"NDC11Code": "12496-1204-03",
"ProductNDC": "12496-1204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20120824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022410",
"LabelerName": "INDIVIOR INC.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "4; 1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120824",
"SamplePackage": "N",
"IndicationAndUsage": "SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "12496-1208-3",
"PackageDescription": "30 POUCH in 1 CARTON (12496-1208-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1208-1) ",
"NDC11Code": "12496-1208-03",
"ProductNDC": "12496-1208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022410",
"LabelerName": "INDIVIOR INC.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "8; 2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100913",
"SamplePackage": "N",
"IndicationAndUsage": "SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "12496-1212-3",
"PackageDescription": "30 POUCH in 1 CARTON (12496-1212-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1212-1) ",
"NDC11Code": "12496-1212-03",
"ProductNDC": "12496-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20120824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022410",
"LabelerName": "INDIVIOR INC.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "12; 3",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120824",
"SamplePackage": "N",
"IndicationAndUsage": "SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "12496-1306-2",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (12496-1306-2)",
"NDC11Code": "12496-1306-02",
"ProductNDC": "12496-1306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20021008",
"EndMarketingDate": "20140501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020733",
"LabelerName": "Reckitt Benckiser Pharmaceuticals Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
"StrengthNumber": "8; 2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-05-05"
},
{
"NDCCode": "0003-1100-14",
"PackageDescription": "14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-1100-14) ",
"NDC11Code": "00003-1100-14",
"ProductNDC": "0003-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "Y",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-1100-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-1100-60) ",
"NDC11Code": "00003-1100-60",
"ProductNDC": "0003-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "N",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-1100-98",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0003-1100-98) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK",
"NDC11Code": "00003-1100-98",
"ProductNDC": "0003-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "XANOMELINE; TROSPIUM CHLORIDE",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-5150-14",
"PackageDescription": "1 KIT in 1 CARTON (0003-5150-14) * 1 BLISTER PACK in 1 PACKAGE (0003-0050-00) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE (0003-1100-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK",
"NDC11Code": "00003-5150-14",
"ProductNDC": "0003-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "Y",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0003-5200-56",
"PackageDescription": "1 KIT in 1 CARTON (0003-5200-56) * 1 BLISTER PACK in 1 PACKAGE (0003-0050-04) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE (0003-1100-01) / 52 CAPSULE, COATED PELLETS in 1 BLISTER PACK",
"NDC11Code": "00003-5200-56",
"ProductNDC": "0003-5200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cobenfy",
"NonProprietaryName": "Xanomeline And Trospium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216158",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "N",
"IndicationAndUsage": "COBENFY is indicated for the treatment of schizophrenia in adults.",
"Description": "COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium)."
},
{
"NDCCode": "0004-1100-20",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1100-20) ",
"NDC11Code": "00004-1100-20",
"ProductNDC": "0004-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xeloda",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980430",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020896",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980430",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).",
"Description": "Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C15H22FN3O6 and a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C. XELODA (capecitabine) is supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides."
},
{
"NDCCode": "0004-1100-75",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0004-1100-75) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00004-1100-75",
"ProductNDC": "0004-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xeloda",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020896",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-02"
},
{
"NDCCode": "0046-1100-51",
"PackageDescription": "1 POUCH in 1 CARTON (0046-1100-51) > 1 BLISTER PACK in 1 POUCH > 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00046-1100-51",
"ProductNDC": "0046-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Estrogens, Conjugated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20060101",
"SamplePackage": "N"
},
{
"NDCCode": "0046-1100-52",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1100-52) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00046-1100-52",
"ProductNDC": "0046-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Estrogens, Conjugated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191111",
"SamplePackage": "N",
"IndicationAndUsage": "PREMARIN is a mixture of estrogens indicated for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2) , 3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3) , 4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease (1.4) , 5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) (1.5) , 6 Prevention of Postmenopausal Osteoporosis (1.6) .",
"Description": "PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of CE purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of CE. PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:. PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below."
},
{
"NDCCode": "0046-1100-81",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0046-1100-81) ",
"NDC11Code": "00046-1100-81",
"ProductNDC": "0046-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Estrogens, Conjugated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060101",
"SamplePackage": "N",
"IndicationAndUsage": "PREMARIN is a mixture of estrogens indicated for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2) , 3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3) , 4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease (1.4) , 5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) (1.5) , 6 Prevention of Postmenopausal Osteoporosis (1.6) .",
"Description": "PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of CE purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of CE. PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:. PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below."
},
{
"NDCCode": "0046-1100-91",
"PackageDescription": "1 BOTTLE in 1 CARTON (0046-1100-91) / 1000 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00046-1100-91",
"ProductNDC": "0046-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Estrogens, Conjugated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060101",
"SamplePackage": "N",
"IndicationAndUsage": "PREMARIN is a mixture of estrogens indicated for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2) , 3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3) , 4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease (1.4) , 5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) (1.5) , 6 Prevention of Postmenopausal Osteoporosis (1.6) .",
"Description": "PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of CE purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of CE. PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:. PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below."
},
{
"NDCCode": "0054-1100-58",
"PackageDescription": "236.5 mL in 1 BOTTLE, PLASTIC (0054-1100-58) ",
"NDC11Code": "00054-1100-58",
"ProductNDC": "0054-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminocaproic Acid",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20190312",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA015230",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": ".25",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241112",
"SamplePackage": "N",
"IndicationAndUsage": "Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings.).",
"Description": "Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is: 1 ."
},
{
"NDCCode": "0064-1100-59",
"PackageDescription": "50 g in 1 BOTTLE, PLASTIC (0064-1100-59)",
"NDC11Code": "00064-1100-59",
"ProductNDC": "0064-1100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Outlast",
"ProprietaryNameSuffix": "Long-lasting Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "HEALTHPOINT, LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
},
{
"NDCCode": "0121-1100-04",
"PackageDescription": "5 mL in 1 BOTTLE (0121-1100-04) ",
"NDC11Code": "00121-1100-04",
"ProductNDC": "0121-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Sodium Phosphate",
"NonProprietaryName": "Prednisolone Sodium Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019157",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "PREDNISOLONE SODIUM PHOSPHATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260626",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions. 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.3. Edematous States To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia.4. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.5. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.6. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.7. Neoplastic Diseases For the treatment of acute leukemia and aggressive lymphomas in adults and children.8. Nervous System Acute exacerbations of multiple sclerosis.9. Ophthalmic Diseases Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.10. Respiratory Diseases Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti- PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia.11. Rheumatic DisordersAs adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis.12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).",
"Description": "Prednisolone Sodium Phosphate Oral Solution is a dye free, colorless to light strawcolored, raspberry flavored solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone Sodium Phosphate Oral Solution also contains dibasic sodium phosphate, edetate disodium, methylparaben, purified water, sodium biphosphate, sorbitol, natural and artificial raspberry flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt,(11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. The chemical structure is:. Pharmacological Category: Glucocorticoid."
},
{
"NDCCode": "0363-1100-06",
"PackageDescription": "6 GRANULE, FOR SOLUTION in 1 BOX (0363-1100-06)",
"NDC11Code": "00363-1100-06",
"ProductNDC": "0363-1100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens Daytime Wal-flu Severe Cold And Cough",
"ProprietaryNameSuffix": "Berry Infused With Menthol And Green Tea Flavors",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr And Phenylephrine Hcl",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Co.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "When using this product - do not exceed recommended dosage."
}
]
}
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<NDCList>
<NDC>
<NDCCode>12496-1100-1</NDCCode>
<PackageDescription>130 kg in 1 DRUM (12496-1100-1)</PackageDescription>
<NDC11Code>12496-1100-01</NDC11Code>
<ProductNDC>12496-1100</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20021020</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indivior Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12496-0003-2</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>12496-0003-02</NDC11Code>
<ProductNDC>12496-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opvee</ProprietaryName>
<NonProprietaryName>Nalmefene Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20231002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217470</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<SubstanceName>NALMEFENE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.7</StrengthNumber>
<StrengthUnit>mg/100uL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPVEE nasal spray is indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. OPVEE nasal spray is not a substitute for emergency medical care.</IndicationAndUsage>
<Description>OPVEE (nalmefene) nasal spray is a pre-filled, unit-dose intranasal spray. Nalmefene, an opioid antagonist, is a 6-methylene analogue of naltrexone. The molecular structure of nalmefene is presented below. Molecular Formula: C 21H 25NO 3∙HCl. Molecular Weight: 375.9, CAS # 58895-64-0. Chemical Name: 17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt. Nalmefene is a white to off-white crystalline powder which is freely soluble in methanol and water, with a pK of 7.63. Each OPVEE nasal spray unit delivers 2.7 mg nalmefene (equivalent to 3mg nalmefene hydrochloride) in 0.1 mL solution. Inactive ingredients include benzalkonium chloride, disodium ethylenediaminetetraacetate, dodecylmaltoside, sodium chloride, and purified water. The pH range is 4.1 to 4.9.</Description>
</NDC>
<NDC>
<NDCCode>12496-0090-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (12496-0090-1) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5) </PackageDescription>
<NDC11Code>12496-0090-01</NDC11Code>
<ProductNDC>12496-0090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perseris</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210655</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6).</Description>
</NDC>
<NDC>
<NDCCode>12496-0090-9</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (12496-0090-9) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5) </PackageDescription>
<NDC11Code>12496-0090-09</NDC11Code>
<ProductNDC>12496-0090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perseris</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210655</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190212</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6).</Description>
</NDC>
<NDC>
<NDCCode>12496-0100-1</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (12496-0100-1) / 1 SYRINGE in 1 POUCH (12496-0100-2) / 1 SOLUTION in 1 SYRINGE (12496-0100-5) </PackageDescription>
<NDC11Code>12496-0100-01</NDC11Code>
<ProductNDC>12496-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sublocade</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209819</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBLOCADE (buprenorphine extended-release) injection is a clear, viscous, colorless to yellow to amber, sterile solution for subcutaneous injection only. It is designed to deliver buprenorphine at a controlled rate over a one month period. The active ingredient in SUBLOCADE is buprenorphine free base, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist. Buprenorphine is dissolved in the ATRIGEL ®delivery system at 18% by weight. The ATRIGEL ®delivery system is a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). SUBLOCADE is provided in dosage strengths of 100 mg and 300 mg. Table 6presents the delivered amounts of the raw materials and the approximate delivered volume for the two dosage strengths. The molecular weight of buprenorphine free base is 467.6, and its molecular formula is C 29H 41NO 4. Chemically, buprenorphine is (2S)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>12496-0120-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (12496-0120-1) * 1 SYRINGE in 1 POUCH (12496-0120-2) / 1.2 mL in 1 SYRINGE (12496-0120-5) * 1 SYRINGE in 1 POUCH (12496-0776-2) / 1 mL in 1 SYRINGE (12496-0776-5) </PackageDescription>
<NDC11Code>12496-0120-01</NDC11Code>
<ProductNDC>12496-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perseris</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210655</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6).</Description>
</NDC>
<NDC>
<NDCCode>12496-0120-9</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (12496-0120-9) * 1 SYRINGE in 1 POUCH (12496-0120-2) / 1.2 mL in 1 SYRINGE (12496-0120-5) * 1 SYRINGE in 1 POUCH (12496-0776-2) / 1 mL in 1 SYRINGE (12496-0776-5) </PackageDescription>
<NDC11Code>12496-0120-09</NDC11Code>
<ProductNDC>12496-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perseris</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210655</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190212</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PERSERIS is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6).</Description>
</NDC>
<NDC>
<NDCCode>12496-0300-1</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5) </PackageDescription>
<NDC11Code>12496-0300-01</NDC11Code>
<ProductNDC>12496-0300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sublocade</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209819</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBLOCADE (buprenorphine extended-release) injection is a clear, viscous, colorless to yellow to amber, sterile solution for subcutaneous injection only. It is designed to deliver buprenorphine at a controlled rate over a one month period. The active ingredient in SUBLOCADE is buprenorphine free base, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist. Buprenorphine is dissolved in the ATRIGEL ®delivery system at 18% by weight. The ATRIGEL ®delivery system is a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). SUBLOCADE is provided in dosage strengths of 100 mg and 300 mg. Table 6presents the delivered amounts of the raw materials and the approximate delivered volume for the two dosage strengths. The molecular weight of buprenorphine free base is 467.6, and its molecular formula is C 29H 41NO 4. Chemically, buprenorphine is (2S)-2-[17-(Cyclopropylmethyl)-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>12496-0757-1</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (12496-0757-1) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>12496-0757-01</NDC11Code>
<ProductNDC>12496-0757</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenex</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19850630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018401</ApplicationNumber>
<LabelerName>Reckitt Benckiser Pharmaceuticals Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>12496-0757-5</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (12496-0757-5) / 1 mL in 1 AMPULE (12496-0757-1) </PackageDescription>
<NDC11Code>12496-0757-05</NDC11Code>
<ProductNDC>12496-0757</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenex</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19850630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018401</ApplicationNumber>
<LabelerName>Indivior Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12496-1202-3</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) </PackageDescription>
<NDC11Code>12496-1202-03</NDC11Code>
<ProductNDC>12496-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride, Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022410</ApplicationNumber>
<LabelerName>INDIVIOR INC.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>12496-1204-3</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (12496-1204-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1) </PackageDescription>
<NDC11Code>12496-1204-03</NDC11Code>
<ProductNDC>12496-1204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride, Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20120824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022410</ApplicationNumber>
<LabelerName>INDIVIOR INC.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>12496-1208-3</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (12496-1208-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1208-1) </PackageDescription>
<NDC11Code>12496-1208-03</NDC11Code>
<ProductNDC>12496-1208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride, Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022410</ApplicationNumber>
<LabelerName>INDIVIOR INC.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>12496-1212-3</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (12496-1212-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1212-1) </PackageDescription>
<NDC11Code>12496-1212-03</NDC11Code>
<ProductNDC>12496-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride, Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20120824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022410</ApplicationNumber>
<LabelerName>INDIVIOR INC.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 3</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>12496-1306-2</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (12496-1306-2)</PackageDescription>
<NDC11Code>12496-1306-02</NDC11Code>
<ProductNDC>12496-1306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
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<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<IndicationAndUsage>COBENFY is indicated for the treatment of schizophrenia in adults.</IndicationAndUsage>
<Description>COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. The chemical name of xanomeline tartrate is pyridine, 3-[4-(hexyloxy)-1,2,5-thiadiazol-3-yl]-1,2,5,6-tetrahydro-1-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1). Its molecular formula is C14H23N3OS.C4H6O6 and its molecular weight is 431.51 g/mol. Xanomeline tartrate is a white to slightly tan crystalline solid. Xanomeline tartrate is highly soluble in protic solvents, such as methanol and water, and in polar organic solvents such as DMF and dimethyl sulfoxide (DMSO). It is poorly soluble in lipophilic organic solvents, such as hexane or octanol. The chemical structure of xanomeline tartrate is. Trospium chloride is a quaternary ammonium compound with the chemical name of spiro[8-azoniabicyclo[3.2.1]octane-8,1′-pyrrolidinium], 3-[(2-hydroxy-2,2-diphenylacetyl)oxy]-, chloride (1:1), (1α,3β,5α). The molecular formula of trospium chloride is C25H30NO3.Cl and its molecular weight is 427.96 g/mol. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. Trospium chloride is highly soluble in water, freely soluble in methanol, and practically insoluble in methylene chloride. The chemical structure of trospium chloride is. COBENFY (xanomeline and trospium chloride) is for oral administration and is available in capsules in the following strengths: 1 50 mg/20 mg (equivalent to 76.7 mg xanomeline tartrate and 18.3 mg trospium)., 2 100 mg/20 mg (equivalent to 153.3 mg xanomeline tartrate and 18.3 mg trospium)., 3 125 mg/30 mg (equivalent to 191.7 mg xanomeline tartrate and 27.5 mg trospium).</Description>
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<IndicationAndUsage>XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for. Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).</IndicationAndUsage>
<Description>Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C15H22FN3O6 and a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C. XELODA (capecitabine) is supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.</Description>
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<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
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<IndicationAndUsage>PREMARIN is a mixture of estrogens indicated for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2) , 3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3) , 4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease (1.4) , 5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) (1.5) , 6 Prevention of Postmenopausal Osteoporosis (1.6) .</IndicationAndUsage>
<Description>PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of CE purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of CE. PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:. PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premarin</ProprietaryName>
<NonProprietaryName>Estrogens, Conjugated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA004782</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREMARIN is a mixture of estrogens indicated for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2) , 3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3) , 4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease (1.4) , 5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) (1.5) , 6 Prevention of Postmenopausal Osteoporosis (1.6) .</IndicationAndUsage>
<Description>PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of CE purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of CE. PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:. PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below.</Description>
</NDC>
<NDC>
<NDCCode>0046-1100-91</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0046-1100-91) / 1000 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00046-1100-91</NDC11Code>
<ProductNDC>0046-1100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premarin</ProprietaryName>
<NonProprietaryName>Estrogens, Conjugated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA004782</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREMARIN is a mixture of estrogens indicated for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2) , 3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3) , 4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease (1.4) , 5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) (1.5) , 6 Prevention of Postmenopausal Osteoporosis (1.6) .</IndicationAndUsage>
<Description>PREMARIN® (conjugated estrogens tablets, USP) for oral administration contains a mixture of CE purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of CE. PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:. PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below.</Description>
</NDC>
<NDC>
<NDCCode>0054-1100-58</NDCCode>
<PackageDescription>236.5 mL in 1 BOTTLE, PLASTIC (0054-1100-58) </PackageDescription>
<NDC11Code>00054-1100-58</NDC11Code>
<ProductNDC>0054-1100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminocaproic Acid</ProprietaryName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190312</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA015230</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings.).</IndicationAndUsage>
<Description>Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is: 1 .</Description>
</NDC>
<NDC>
<NDCCode>0064-1100-59</NDCCode>
<PackageDescription>50 g in 1 BOTTLE, PLASTIC (0064-1100-59)</PackageDescription>
<NDC11Code>00064-1100-59</NDC11Code>
<ProductNDC>0064-1100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Outlast</ProprietaryName>
<ProprietaryNameSuffix>Long-lasting Hand Sanitizer</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>HEALTHPOINT, LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0121-1100-04</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (0121-1100-04) </PackageDescription>
<NDC11Code>00121-1100-04</NDC11Code>
<ProductNDC>0121-1100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisolone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Prednisolone Sodium Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260626</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019157</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions. 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.3. Edematous States To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia.4. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.5. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.6. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.7. Neoplastic Diseases For the treatment of acute leukemia and aggressive lymphomas in adults and children.8. Nervous System Acute exacerbations of multiple sclerosis.9. Ophthalmic Diseases Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.10. Respiratory Diseases Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti- PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia.11. Rheumatic DisordersAs adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis.12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).</IndicationAndUsage>
<Description>Prednisolone Sodium Phosphate Oral Solution is a dye free, colorless to light strawcolored, raspberry flavored solution. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 6.7 mg prednisolone sodium phosphate (5 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone Sodium Phosphate Oral Solution also contains dibasic sodium phosphate, edetate disodium, methylparaben, purified water, sodium biphosphate, sorbitol, natural and artificial raspberry flavor. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is: pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)-,disodium salt,(11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. The chemical structure is:. Pharmacological Category: Glucocorticoid.</Description>
</NDC>
<NDC>
<NDCCode>0363-1100-06</NDCCode>
<PackageDescription>6 GRANULE, FOR SOLUTION in 1 BOX (0363-1100-06)</PackageDescription>
<NDC11Code>00363-1100-06</NDC11Code>
<ProductNDC>0363-1100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens Daytime Wal-flu Severe Cold And Cough</ProprietaryName>
<ProprietaryNameSuffix>Berry Infused With Menthol And Green Tea Flavors</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr And Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Co.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>When using this product - do not exceed recommended dosage.</IndicationAndUsage>
</NDC>
</NDCList>