{
"NDC": [
{
"NDCCode": "0781-3234-34",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0781-3234-34) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3234-71) ",
"NDC11Code": "00781-3234-34",
"ProductNDC": "0781-3234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glatopa",
"NonProprietaryName": "Glatiramer Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090218",
"LabelerName": "Sandoz Inc",
"SubstanceName": "GLATIRAMER ACETATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150618",
"SamplePackage": "N",
"IndicationAndUsage": "Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Glatiramer acetate, the active ingredient of Glatopa, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies. Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is. Glatopa is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of glatiramer acetate injection solution contains 20 mg or 40 mg of glatiramer acetate and the following inactive ingredient: 40 mg of mannitol. The pH of the solutions is approximately 5.5 to 7. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice."
},
{
"NDCCode": "0781-5381-34",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE (0781-5381-34)",
"NDC11Code": "00781-5381-34",
"ProductNDC": "0781-5381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077575",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-5382-34",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE (0781-5382-34)",
"NDC11Code": "00781-5382-34",
"ProductNDC": "0781-5382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077575",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "63354-781-34",
"PackageDescription": "155.24 g in 1 CAN (63354-781-34) ",
"NDC11Code": "63354-0781-34",
"ProductNDC": "63354-781",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Banana Boat",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120104",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Edgewell Personal Care Brands LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 10; 5; 10; 6",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120104",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1358-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0781-1358-01)",
"NDC11Code": "00781-1358-01",
"ProductNDC": "0781-1358",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clemastine Fumarate",
"NonProprietaryName": "Clemastine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19931031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073458",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CLEMASTINE FUMARATE",
"StrengthNumber": "1.34",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-2299-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2299-01) ",
"NDC11Code": "00781-2299-01",
"ProductNDC": "0781-2299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202836",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake."
},
{
"NDCCode": "0781-2476-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2476-01) ",
"NDC11Code": "00781-2476-01",
"ProductNDC": "0781-2476",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202836",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake."
},
{
"NDCCode": "0781-2477-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2477-01) ",
"NDC11Code": "00781-2477-01",
"ProductNDC": "0781-2477",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202836",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake."
},
{
"NDCCode": "0781-2478-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2478-01) ",
"NDC11Code": "00781-2478-01",
"ProductNDC": "0781-2478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202836",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake."
},
{
"NDCCode": "0781-2479-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2479-01) ",
"NDC11Code": "00781-2479-01",
"ProductNDC": "0781-2479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202836",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake."
},
{
"NDCCode": "0781-2480-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2480-01) ",
"NDC11Code": "00781-2480-01",
"ProductNDC": "0781-2480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202836",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake."
},
{
"NDCCode": "0781-2481-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2481-01) ",
"NDC11Code": "00781-2481-01",
"ProductNDC": "0781-2481",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202836",
"LabelerName": "Sandoz Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake."
},
{
"NDCCode": "0781-3485-95",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) ",
"NDC11Code": "00781-3485-95",
"ProductNDC": "0781-3485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "50",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-3485-96",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00781-3485-96",
"ProductNDC": "0781-3485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "50",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-3486-95",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-95) / 5 mL in 1 VIAL, SINGLE-DOSE (0781-3486-75) ",
"NDC11Code": "00781-3486-95",
"ProductNDC": "0781-3486",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-3486-96",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-96) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00781-3486-96",
"ProductNDC": "0781-3486",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-3487-14",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-14) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3487-70) ",
"NDC11Code": "00781-3487-14",
"ProductNDC": "0781-3487",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-3487-92",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-92) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00781-3487-92",
"ProductNDC": "0781-3487",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-3487-94",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-94) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00781-3487-94",
"ProductNDC": "0781-3487",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-6135-95",
"PackageDescription": "10 VIAL in 1 CARTON (0781-6135-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-6135-94) ",
"NDC11Code": "00781-6135-95",
"ProductNDC": "0781-6135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin G Potassium",
"NonProprietaryName": "Penicillin G Potassium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20010830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065079",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PENICILLIN G POTASSIUM",
"StrengthNumber": "5000000",
"StrengthUnit": "[iU]/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2020-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010830",
"SamplePackage": "N",
"IndicationAndUsage": "Buffered penicillin G potassium for injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Buffered penicillin G potassium for injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin G potassium and other antibacterial drugs, penicillin G potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Buffered penicillin G potassium for injection, USP is sterile penicillin G potassium powder for reconstitution. It is an antibacterial agent intended for intravenous or intramuscularly use. Chemically, penicillin G potassium is monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate, and has the following chemical structure. Molecular Formula: C16H17KN2O4S. Molecular Weight: 372.48. Penicillin G potassium, a water soluble benzylpenicillin, is a white to almost white crystalline powder which is almost odorless and/or after reconstitution a colorless solution. The pH of freshly constituted solutions usually ranges from 6 to 8.5. Sodium citrate and citric acid have been added as a buffer. Buffered penicillin G potassium for injection, USP is supplied in vials equivalent to 1,000,000 units (1 million units), 5,000,000 units (5 million units), or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Each million unit contains approximately 7.9 milligrams of sodium (0.34 mEq) and 65.6 milligrams of potassium (1.68 mEq)."
},
{
"NDCCode": "0781-6136-94",
"PackageDescription": "1 VIAL in 1 CARTON (0781-6136-94) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00781-6136-94",
"ProductNDC": "0781-6136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin G Potassium",
"NonProprietaryName": "Penicillin G Potassium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20010830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065079",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PENICILLIN G POTASSIUM",
"StrengthNumber": "20000000",
"StrengthUnit": "[iU]/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2020-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010830",
"SamplePackage": "N",
"IndicationAndUsage": "Buffered penicillin G potassium for injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Buffered penicillin G potassium for injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin G potassium and other antibacterial drugs, penicillin G potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Buffered penicillin G potassium for injection, USP is sterile penicillin G potassium powder for reconstitution. It is an antibacterial agent intended for intravenous or intramuscularly use. Chemically, penicillin G potassium is monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate, and has the following chemical structure. Molecular Formula: C16H17KN2O4S. Molecular Weight: 372.48. Penicillin G potassium, a water soluble benzylpenicillin, is a white to almost white crystalline powder which is almost odorless and/or after reconstitution a colorless solution. The pH of freshly constituted solutions usually ranges from 6 to 8.5. Sodium citrate and citric acid have been added as a buffer. Buffered penicillin G potassium for injection, USP is supplied in vials equivalent to 1,000,000 units (1 million units), 5,000,000 units (5 million units), or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Each million unit contains approximately 7.9 milligrams of sodium (0.34 mEq) and 65.6 milligrams of potassium (1.68 mEq)."
},
{
"NDCCode": "0781-7304-31",
"PackageDescription": "30 PATCH in 1 CARTON (0781-7304-31) / 24 h in 1 PATCH (0781-7304-58) ",
"NDC11Code": "00781-7304-31",
"ProductNDC": "0781-7304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150902",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022083",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "4.6",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150902",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2).",
"Description": "Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E."
},
{
"NDCCode": "0781-7309-31",
"PackageDescription": "30 PATCH in 1 CARTON (0781-7309-31) / 24 h in 1 PATCH (0781-7309-58) ",
"NDC11Code": "00781-7309-31",
"ProductNDC": "0781-7309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150902",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022083",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "9.5",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150902",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2).",
"Description": "Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E."
},
{
"NDCCode": "0781-7313-31",
"PackageDescription": "30 PATCH in 1 CARTON (0781-7313-31) / 24 h in 1 PATCH (0781-7313-58) ",
"NDC11Code": "00781-7313-31",
"ProductNDC": "0781-7313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150902",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022083",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "13.3",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150902",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2).",
"Description": "Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E."
},
{
"NDCCode": "31722-781-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "31722-0781-30",
"ProductNDC": "31722-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Afatinib",
"NonProprietaryName": "Afatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210750",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AFATINIB DIMALEATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260714",
"SamplePackage": "N",
"IndicationAndUsage": "Afatinib tablets are a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1) Limitations of Use: Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2).",
"Description": "Afatinib tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-,(2Z)-2-butenedioate(1:2). Its structural formula is. Afatinib dimaleate is an off-white to yellow color, hygroscopic powder, slightly soluble in dimethyl sulfoxide, dimethylformamide and very slightly soluble in water, with an empirical formula of C 24H 25ClFN 5O 3.2C 4H 4O 4(1:2), and a relative molecular mass of 718.09. Afatinib tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of afatinib tablets are the following: Tablet Core: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Coating: hypromellose, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "0002-3234-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3234-30) ",
"NDC11Code": "00002-3234-30",
"ProductNDC": "0002-3234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbyax",
"NonProprietaryName": "Olanzapine And Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20031224",
"EndMarketingDate": "20210426",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021520",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "12; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040119",
"EndMarketingDatePackage": "20210426",
"SamplePackage": "N"
},
{
"NDCCode": "0007-3234-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0007-3234-02) > .6 mL in 1 SYRINGE (0007-3234-01)",
"NDC11Code": "00007-3234-02",
"ProductNDC": "0007-3234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arixtra",
"NonProprietaryName": "Fondaparinux Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20041117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021345",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FONDAPARINUX SODIUM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "0007-3234-11",
"PackageDescription": "10 SYRINGE in 1 CARTON (0007-3234-11) > .6 mL in 1 SYRINGE",
"NDC11Code": "00007-3234-11",
"ProductNDC": "0007-3234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arixtra",
"NonProprietaryName": "Fondaparinux Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20041117",
"EndMarketingDate": "20161130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021345",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FONDAPARINUX SODIUM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0007-3234-61",
"PackageDescription": "2 SYRINGE in 1 CARTON (0007-3234-61) > .6 mL in 1 SYRINGE",
"NDC11Code": "00007-3234-61",
"ProductNDC": "0007-3234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arixtra",
"NonProprietaryName": "Fondaparinux Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20041117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021345",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "FONDAPARINUX SODIUM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "0093-3234-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01) ",
"NDC11Code": "00093-3234-01",
"ProductNDC": "0093-3234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfasalazine",
"NonProprietaryName": "Sulfasalazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085828",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "SULFASALAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221215",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfasalazine tablets are indicated. a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; andb) for the prolongation of the remission period between acute attacks of ulcerative colitis.",
"Description": "Sulfasalazine tablets USP, 500 mg for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. C18H14N4O5S. The molecular weight of sulfasalazine is 398.39. Inactive Ingredients: magnesium stearate, pregelatinized corn starch, sodium starch glycolate and stearic acid."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0781-3234-34</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (0781-3234-34) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3234-71) </PackageDescription>
<NDC11Code>00781-3234-34</NDC11Code>
<ProductNDC>0781-3234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glatopa</ProprietaryName>
<NonProprietaryName>Glatiramer Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090218</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>GLATIRAMER ACETATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Glatiramer acetate, the active ingredient of Glatopa, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies. Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is. Glatopa is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of glatiramer acetate injection solution contains 20 mg or 40 mg of glatiramer acetate and the following inactive ingredient: 40 mg of mannitol. The pH of the solutions is approximately 5.5 to 7. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.</Description>
</NDC>
<NDC>
<NDCCode>0781-5381-34</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (0781-5381-34)</PackageDescription>
<NDC11Code>00781-5381-34</NDC11Code>
<ProductNDC>0781-5381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077575</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-5382-34</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (0781-5382-34)</PackageDescription>
<NDC11Code>00781-5382-34</NDC11Code>
<ProductNDC>0781-5382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077575</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>63354-781-34</NDCCode>
<PackageDescription>155.24 g in 1 CAN (63354-781-34) </PackageDescription>
<NDC11Code>63354-0781-34</NDC11Code>
<ProductNDC>63354-781</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Banana Boat</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Edgewell Personal Care Brands LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 10; 5; 10; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1358-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0781-1358-01)</PackageDescription>
<NDC11Code>00781-1358-01</NDC11Code>
<ProductNDC>0781-1358</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clemastine Fumarate</ProprietaryName>
<NonProprietaryName>Clemastine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073458</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>CLEMASTINE FUMARATE</SubstanceName>
<StrengthNumber>1.34</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-2299-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2299-01) </PackageDescription>
<NDC11Code>00781-2299-01</NDC11Code>
<ProductNDC>0781-2299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202836</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-2476-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2476-01) </PackageDescription>
<NDC11Code>00781-2476-01</NDC11Code>
<ProductNDC>0781-2476</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202836</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-2477-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2477-01) </PackageDescription>
<NDC11Code>00781-2477-01</NDC11Code>
<ProductNDC>0781-2477</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202836</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-2478-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2478-01) </PackageDescription>
<NDC11Code>00781-2478-01</NDC11Code>
<ProductNDC>0781-2478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202836</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-2479-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2479-01) </PackageDescription>
<NDC11Code>00781-2479-01</NDC11Code>
<ProductNDC>0781-2479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202836</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-2480-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2480-01) </PackageDescription>
<NDC11Code>00781-2480-01</NDC11Code>
<ProductNDC>0781-2480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202836</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-2481-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2481-01) </PackageDescription>
<NDC11Code>00781-2481-01</NDC11Code>
<ProductNDC>0781-2481</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202836</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-3485-95</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) </PackageDescription>
<NDC11Code>00781-3485-95</NDC11Code>
<ProductNDC>0781-3485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-3485-96</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00781-3485-96</NDC11Code>
<ProductNDC>0781-3485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-3486-95</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-95) / 5 mL in 1 VIAL, SINGLE-DOSE (0781-3486-75) </PackageDescription>
<NDC11Code>00781-3486-95</NDC11Code>
<ProductNDC>0781-3486</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-3486-96</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-96) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00781-3486-96</NDC11Code>
<ProductNDC>0781-3486</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-3487-14</NDCCode>
<PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-14) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3487-70) </PackageDescription>
<NDC11Code>00781-3487-14</NDC11Code>
<ProductNDC>0781-3487</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-3487-92</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-92) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00781-3487-92</NDC11Code>
<ProductNDC>0781-3487</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-3487-94</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-94) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00781-3487-94</NDC11Code>
<ProductNDC>0781-3487</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-6135-95</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0781-6135-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-6135-94) </PackageDescription>
<NDC11Code>00781-6135-95</NDC11Code>
<ProductNDC>0781-6135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin G Potassium</ProprietaryName>
<NonProprietaryName>Penicillin G Potassium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20010830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065079</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>PENICILLIN G POTASSIUM</SubstanceName>
<StrengthNumber>5000000</StrengthNumber>
<StrengthUnit>[iU]/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buffered penicillin G potassium for injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Buffered penicillin G potassium for injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin G potassium and other antibacterial drugs, penicillin G potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Buffered penicillin G potassium for injection, USP is sterile penicillin G potassium powder for reconstitution. It is an antibacterial agent intended for intravenous or intramuscularly use. Chemically, penicillin G potassium is monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate, and has the following chemical structure. Molecular Formula: C16H17KN2O4S. Molecular Weight: 372.48. Penicillin G potassium, a water soluble benzylpenicillin, is a white to almost white crystalline powder which is almost odorless and/or after reconstitution a colorless solution. The pH of freshly constituted solutions usually ranges from 6 to 8.5. Sodium citrate and citric acid have been added as a buffer. Buffered penicillin G potassium for injection, USP is supplied in vials equivalent to 1,000,000 units (1 million units), 5,000,000 units (5 million units), or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Each million unit contains approximately 7.9 milligrams of sodium (0.34 mEq) and 65.6 milligrams of potassium (1.68 mEq).</Description>
</NDC>
<NDC>
<NDCCode>0781-6136-94</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0781-6136-94) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>00781-6136-94</NDC11Code>
<ProductNDC>0781-6136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin G Potassium</ProprietaryName>
<NonProprietaryName>Penicillin G Potassium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20010830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065079</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>PENICILLIN G POTASSIUM</SubstanceName>
<StrengthNumber>20000000</StrengthNumber>
<StrengthUnit>[iU]/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buffered penicillin G potassium for injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Buffered penicillin G potassium for injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin G potassium and other antibacterial drugs, penicillin G potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Buffered penicillin G potassium for injection, USP is sterile penicillin G potassium powder for reconstitution. It is an antibacterial agent intended for intravenous or intramuscularly use. Chemically, penicillin G potassium is monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate, and has the following chemical structure. Molecular Formula: C16H17KN2O4S. Molecular Weight: 372.48. Penicillin G potassium, a water soluble benzylpenicillin, is a white to almost white crystalline powder which is almost odorless and/or after reconstitution a colorless solution. The pH of freshly constituted solutions usually ranges from 6 to 8.5. Sodium citrate and citric acid have been added as a buffer. Buffered penicillin G potassium for injection, USP is supplied in vials equivalent to 1,000,000 units (1 million units), 5,000,000 units (5 million units), or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Each million unit contains approximately 7.9 milligrams of sodium (0.34 mEq) and 65.6 milligrams of potassium (1.68 mEq).</Description>
</NDC>
<NDC>
<NDCCode>0781-7304-31</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (0781-7304-31) / 24 h in 1 PATCH (0781-7304-58) </PackageDescription>
<NDC11Code>00781-7304-31</NDC11Code>
<ProductNDC>0781-7304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150902</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022083</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>4.6</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2).</IndicationAndUsage>
<Description>Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.</Description>
</NDC>
<NDC>
<NDCCode>0781-7309-31</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (0781-7309-31) / 24 h in 1 PATCH (0781-7309-58) </PackageDescription>
<NDC11Code>00781-7309-31</NDC11Code>
<ProductNDC>0781-7309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150902</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022083</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>9.5</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2).</IndicationAndUsage>
<Description>Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.</Description>
</NDC>
<NDC>
<NDCCode>0781-7313-31</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (0781-7313-31) / 24 h in 1 PATCH (0781-7313-58) </PackageDescription>
<NDC11Code>00781-7313-31</NDC11Code>
<ProductNDC>0781-7313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150902</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022083</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>13.3</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2).</IndicationAndUsage>
<Description>Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.</Description>
</NDC>
<NDC>
<NDCCode>31722-781-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0781-30</NDC11Code>
<ProductNDC>31722-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Afatinib</ProprietaryName>
<NonProprietaryName>Afatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210750</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AFATINIB DIMALEATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Afatinib tablets are a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1) Limitations of Use: Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2).</IndicationAndUsage>
<Description>Afatinib tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-,(2Z)-2-butenedioate(1:2). Its structural formula is. Afatinib dimaleate is an off-white to yellow color, hygroscopic powder, slightly soluble in dimethyl sulfoxide, dimethylformamide and very slightly soluble in water, with an empirical formula of C 24H 25ClFN 5O 3.2C 4H 4O 4(1:2), and a relative molecular mass of 718.09. Afatinib tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of afatinib tablets are the following: Tablet Core: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Coating: hypromellose, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0002-3234-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3234-30) </PackageDescription>
<NDC11Code>00002-3234-30</NDC11Code>
<ProductNDC>0002-3234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbyax</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031224</StartMarketingDate>
<EndMarketingDate>20210426</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021520</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040119</StartMarketingDatePackage>
<EndMarketingDatePackage>20210426</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0007-3234-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0007-3234-02) > .6 mL in 1 SYRINGE (0007-3234-01)</PackageDescription>
<NDC11Code>00007-3234-02</NDC11Code>
<ProductNDC>0007-3234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arixtra</ProprietaryName>
<NonProprietaryName>Fondaparinux Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20041117</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021345</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FONDAPARINUX SODIUM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0007-3234-11</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0007-3234-11) > .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00007-3234-11</NDC11Code>
<ProductNDC>0007-3234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arixtra</ProprietaryName>
<NonProprietaryName>Fondaparinux Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20041117</StartMarketingDate>
<EndMarketingDate>20161130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021345</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FONDAPARINUX SODIUM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0007-3234-61</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0007-3234-61) > .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00007-3234-61</NDC11Code>
<ProductNDC>0007-3234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arixtra</ProprietaryName>
<NonProprietaryName>Fondaparinux Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20041117</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021345</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>FONDAPARINUX SODIUM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0093-3234-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01) </PackageDescription>
<NDC11Code>00093-3234-01</NDC11Code>
<ProductNDC>0093-3234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfasalazine</ProprietaryName>
<NonProprietaryName>Sulfasalazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085828</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>SULFASALAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfasalazine tablets are indicated. a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; andb) for the prolongation of the remission period between acute attacks of ulcerative colitis.</IndicationAndUsage>
<Description>Sulfasalazine tablets USP, 500 mg for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. C18H14N4O5S. The molecular weight of sulfasalazine is 398.39. Inactive Ingredients: magnesium stearate, pregelatinized corn starch, sodium starch glycolate and stearic acid.</Description>
</NDC>
</NDCList>