{
"NDC": [
{
"NDCCode": "66758-237-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-237-31) ",
"NDC11Code": "66758-0237-31",
"ProductNDC": "66758-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-237-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-237-01) ",
"NDC11Code": "66758-0237-01",
"ProductNDC": "66758-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241004",
"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "46708-237-31",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (46708-237-31) ",
"NDC11Code": "46708-0237-31",
"ProductNDC": "46708-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214031",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200805",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride is a white or slightly brown or yellow powder with a molecular weight of 579.11. It is slightly soluble in water, freely soluble in anhydrous ethanol. Practically insoluble in heptane. Vardenafil hydrochloride is available as film-coated tablets for oral administration, containing 2.5 mg, 5 mg, 10 mg and 20 mg of vardenafil. The inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, talc, colloidal silicon dioxide and magnesium stearate. The colorants include hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow, iron oxide red, FD&C Yellow No. 5 Tartrazine Aluminum Lake and FD&C Yellow No. 6 Sunset Yellow FCF Aluminum Lake."
},
{
"NDCCode": "62332-237-31",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (62332-237-31) ",
"NDC11Code": "62332-0237-31",
"ProductNDC": "62332-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214031",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200805",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride is a white or slightly brown or yellow powder with a molecular weight of 579.11. It is slightly soluble in water, freely soluble in anhydrous ethanol. Practically insoluble in heptane. Vardenafil hydrochloride is available as film-coated tablets for oral administration, containing 2.5 mg, 5 mg, 10 mg and 20 mg of vardenafil. The inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, talc, colloidal silicon dioxide and magnesium stearate. The colorants include hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow, iron oxide red, FD&C Yellow No. 5 Tartrazine Aluminum Lake and FD&C Yellow No. 6 Sunset Yellow FCF Aluminum Lake."
},
{
"NDCCode": "66758-142-31",
"PackageDescription": "30 PATCH in 1 CARTON (66758-142-31) / 24 h in 1 PATCH (66758-142-58) ",
"NDC11Code": "66758-0142-31",
"ProductNDC": "66758-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelon",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20070706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022083",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "4.6",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251003",
"SamplePackage": "N",
"IndicationAndUsage": "EXELON PATCH 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": "EXELON PATCH (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. EXELON PATCH 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 EXELON PATCH. 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": "66758-143-31",
"PackageDescription": "30 PATCH in 1 CARTON (66758-143-31) / 24 h in 1 PATCH (66758-143-58) ",
"NDC11Code": "66758-0143-31",
"ProductNDC": "66758-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelon",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20070706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022083",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "9.5",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251003",
"SamplePackage": "N",
"IndicationAndUsage": "EXELON PATCH 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": "EXELON PATCH (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. EXELON PATCH 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 EXELON PATCH. 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": "66758-144-31",
"PackageDescription": "30 PATCH in 1 CARTON (66758-144-31) / 24 h in 1 PATCH (66758-144-58) ",
"NDC11Code": "66758-0144-31",
"ProductNDC": "66758-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelon",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20070706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022083",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "13.3",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251003",
"SamplePackage": "N",
"IndicationAndUsage": "EXELON PATCH 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": "EXELON PATCH (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. EXELON PATCH 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 EXELON PATCH. 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": "66758-211-31",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31) ",
"NDC11Code": "66758-0211-31",
"ProductNDC": "66758-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lescol",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Fluvastatin Sodium",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20001006",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021192",
"LabelerName": "Sandoz Inc",
"SubstanceName": "FLUVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240802",
"SamplePackage": "N",
"IndicationAndUsage": "LESCOL XL is indicated: : 1 To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. , 3 As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily.",
"Description": "Fluvastatin sodium inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of fluvastatin sodium is C24H25FNO4Na, its molecular weight is 433.46 g/mol and its structural formula is. Fluvastatin sodium is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. LESCOL XL is supplied as extended-release tablets containing 84.24 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral use. LESCOL XL tablets contain the following inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, potassium bicarbonate, povidone, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "66758-235-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-235-31) ",
"NDC11Code": "66758-0235-31",
"ProductNDC": "66758-235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-236-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-236-31) ",
"NDC11Code": "66758-0236-31",
"ProductNDC": "66758-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251216",
"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-238-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-238-31) ",
"NDC11Code": "66758-0238-31",
"ProductNDC": "66758-238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
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"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-239-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-239-31) ",
"NDC11Code": "66758-0239-31",
"ProductNDC": "66758-239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
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"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-240-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-240-31) ",
"NDC11Code": "66758-0240-31",
"ProductNDC": "66758-240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-241-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-241-31) ",
"NDC11Code": "66758-0241-31",
"ProductNDC": "66758-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-242-31",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-242-31) ",
"NDC11Code": "66758-0242-31",
"ProductNDC": "66758-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Focalin",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021802",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow."
},
{
"NDCCode": "66758-040-02",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (66758-040-02) > 2 mL in 1 VIAL, SINGLE-DOSE (66758-040-01)",
"NDC11Code": "66758-0040-02",
"ProductNDC": "66758-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate Sodium",
"NonProprietaryName": "Methotrexate Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090039",
"LabelerName": "Sandoz Inc",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "66758-040-08",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (66758-040-08) > 10 mL in 1 VIAL, SINGLE-DOSE (66758-040-07)",
"NDC11Code": "66758-0040-08",
"ProductNDC": "66758-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate Sodium",
"NonProprietaryName": "Methotrexate Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090039",
"LabelerName": "Sandoz Inc",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "66758-041-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (66758-041-01) > 40 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "66758-0041-01",
"ProductNDC": "66758-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate Sodium",
"NonProprietaryName": "Methotrexate Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090029",
"LabelerName": "Sandoz Inc",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "66758-050-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-01) / 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "66758-0050-01",
"ProductNDC": "66758-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110629",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201525",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110629",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80."
},
{
"NDCCode": "66758-050-02",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-02) / 8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "66758-0050-02",
"ProductNDC": "66758-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110629",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201525",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110629",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80."
},
{
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"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (66758-050-03) / 16 mL in 1 VIAL, MULTI-DOSE",
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"ProductNDC": "66758-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110629",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201525",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
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"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80."
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"ProductNDC": "0220-5100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
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"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "9; 9; 9; 9",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Active",
"LastUpdate": "2024-10-01",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241001",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: See symptoms on front panel. Relieves after effects of flu or flu-like symptoms *."
},
{
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"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (0536-1287-36) ",
"NDC11Code": "00536-1287-36",
"ProductNDC": "0536-1287",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200329",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Rugby Laboratories, Inc.",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200329",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching."
},
{
"NDCCode": "0781-1874-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0781-1874-31) ",
"NDC11Code": "00781-1874-31",
"ProductNDC": "0781-1874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065189",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"IndicationAndUsage": "Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and clavulanate potassium tablets, USP and for oral suspension, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)."
},
{
"NDCCode": "11701-052-05",
"PackageDescription": "237 mL in 1 BOTTLE, SPRAY (11701-052-05) ",
"NDC11Code": "11701-0052-05",
"ProductNDC": "11701-052",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bedside-care Foam",
"ProprietaryNameSuffix": "(alcohol Free)",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Coloplast Corp",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": "Uses Protects against the risk of bacterial contamination in minor cuts, scraps and burns."
},
{
"NDCCode": "11701-053-05",
"PackageDescription": "237 mL in 1 BOTTLE, SPRAY (11701-053-05) ",
"NDC11Code": "11701-0053-05",
"ProductNDC": "11701-053",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bedside-care",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
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"LabelerName": "Coloplast Corp",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090615",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Protects against the risk of bacterial contamination in minor cuts, scraps and burns."
},
{
"NDCCode": "11822-0110-8",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (11822-0110-8) ",
"NDC11Code": "11822-0110-08",
"ProductNDC": "11822-0110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peptic Relief",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090603",
"EndMarketingDate": "20191230",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090603",
"EndMarketingDatePackage": "20191230",
"SamplePackage": "N"
},
{
"NDCCode": "11822-0413-8",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (11822-0413-8) ",
"NDC11Code": "11822-0413-08",
"ProductNDC": "11822-0413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Original",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090716",
"EndMarketingDate": "20191230",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090716",
"EndMarketingDatePackage": "20191230",
"SamplePackage": "N"
},
{
"NDCCode": "15127-085-08",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (15127-085-08) > 237 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "15127-0085-08",
"ProductNDC": "15127-085",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Cough And Chest Congestion Dm",
"ProprietaryNameSuffix": "Adult",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "Select Brand Dist.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 200",
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"PackageNdcExcludeFlag": "N",
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},
{
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"LabelerName": "Select Brand Dist.",
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"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
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"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
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<NDCList>
<NDC>
<NDCCode>66758-237-31</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-237-31) </PackageDescription>
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<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
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<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
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<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214031</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride is a white or slightly brown or yellow powder with a molecular weight of 579.11. It is slightly soluble in water, freely soluble in anhydrous ethanol. Practically insoluble in heptane. Vardenafil hydrochloride is available as film-coated tablets for oral administration, containing 2.5 mg, 5 mg, 10 mg and 20 mg of vardenafil. The inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, talc, colloidal silicon dioxide and magnesium stearate. The colorants include hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow, iron oxide red, FD&C Yellow No. 5 Tartrazine Aluminum Lake and FD&C Yellow No. 6 Sunset Yellow FCF Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>62332-237-31</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (62332-237-31) </PackageDescription>
<NDC11Code>62332-0237-31</NDC11Code>
<ProductNDC>62332-237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214031</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride is a white or slightly brown or yellow powder with a molecular weight of 579.11. It is slightly soluble in water, freely soluble in anhydrous ethanol. Practically insoluble in heptane. Vardenafil hydrochloride is available as film-coated tablets for oral administration, containing 2.5 mg, 5 mg, 10 mg and 20 mg of vardenafil. The inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, talc, colloidal silicon dioxide and magnesium stearate. The colorants include hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow, iron oxide red, FD&C Yellow No. 5 Tartrazine Aluminum Lake and FD&C Yellow No. 6 Sunset Yellow FCF Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>66758-142-31</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (66758-142-31) / 24 h in 1 PATCH (66758-142-58) </PackageDescription>
<NDC11Code>66758-0142-31</NDC11Code>
<ProductNDC>66758-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelon</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20070706</StartMarketingDate>
<MarketingCategoryName>NDA</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>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXELON PATCH 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>EXELON PATCH (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. EXELON PATCH 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 EXELON PATCH. 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>66758-143-31</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (66758-143-31) / 24 h in 1 PATCH (66758-143-58) </PackageDescription>
<NDC11Code>66758-0143-31</NDC11Code>
<ProductNDC>66758-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelon</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20070706</StartMarketingDate>
<MarketingCategoryName>NDA</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>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXELON PATCH 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>EXELON PATCH (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. EXELON PATCH 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 EXELON PATCH. 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>66758-144-31</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (66758-144-31) / 24 h in 1 PATCH (66758-144-58) </PackageDescription>
<NDC11Code>66758-0144-31</NDC11Code>
<ProductNDC>66758-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelon</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20070706</StartMarketingDate>
<MarketingCategoryName>NDA</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>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXELON PATCH 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>EXELON PATCH (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. EXELON PATCH 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 EXELON PATCH. 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>66758-211-31</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31) </PackageDescription>
<NDC11Code>66758-0211-31</NDC11Code>
<ProductNDC>66758-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lescol</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Fluvastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001006</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021192</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>FLUVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LESCOL XL is indicated: : 1 To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. , 3 As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily.</IndicationAndUsage>
<Description>Fluvastatin sodium inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [R*,S*-(E)]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of fluvastatin sodium is C24H25FNO4Na, its molecular weight is 433.46 g/mol and its structural formula is. Fluvastatin sodium is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. LESCOL XL is supplied as extended-release tablets containing 84.24 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral use. LESCOL XL tablets contain the following inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, potassium bicarbonate, povidone, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>66758-235-31</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-235-31) </PackageDescription>
<NDC11Code>66758-0235-31</NDC11Code>
<ProductNDC>66758-235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Focalin</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021802</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</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>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>66758-236-31</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-236-31) </PackageDescription>
<NDC11Code>66758-0236-31</NDC11Code>
<ProductNDC>66758-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Focalin</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021802</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</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>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>66758-238-31</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-238-31) </PackageDescription>
<NDC11Code>66758-0238-31</NDC11Code>
<ProductNDC>66758-238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Focalin</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021802</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</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>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>66758-239-31</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-239-31) </PackageDescription>
<NDC11Code>66758-0239-31</NDC11Code>
<ProductNDC>66758-239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Focalin</ProprietaryName>
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<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
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<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
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<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
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<IndicationAndUsage>Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: E132 FD&C Blue No. 2, 2 10 mg: FDA/E172 iron oxide yellow, 3 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow, 4 20 mg: contains no colorants, 5 25 mg: E132 FD&C Blue No. 2, 6 30 mg: FDA/E172 iron oxide yellow, 7 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow, 8 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow.</Description>
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<LastUpdate>2019-05-31</LastUpdate>
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<LastUpdate>2019-05-31</LastUpdate>
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<ProprietaryName>Docetaxel</ProprietaryName>
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<LabelerName>Sandoz Inc.</LabelerName>
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<LastUpdate>2024-08-31</LastUpdate>
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<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80.</Description>
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<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80.</Description>
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<StartMarketingDatePackage>20110629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>0220-5100-31</NDCCode>
<PackageDescription>1 PELLET in 1 TUBE (0220-5100-31) </PackageDescription>
<NDC11Code>00220-5100-31</NDC11Code>
<ProductNDC>0220-5100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/thailand/8/2022 Ivr-237 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>9; 9; 9; 9</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: See symptoms on front panel. Relieves after effects of flu or flu-like symptoms *.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0536-1287-36</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (0536-1287-36) </PackageDescription>
<NDC11Code>00536-1287-36</NDC11Code>
<ProductNDC>0536-1287</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief</ProprietaryName>
<ProprietaryNameSuffix>Ultra</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200329</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Rugby Laboratories, Inc.</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 travelers' diarrhea , 2 diarrhea , 3 upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0781-1874-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-1874-31) </PackageDescription>
<NDC11Code>00781-1874-31</NDC11Code>
<ProductNDC>0781-1874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065189</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, USP and for oral suspension, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(phydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 3 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).</Description>
</NDC>
<NDC>
<NDCCode>11701-052-05</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, SPRAY (11701-052-05) </PackageDescription>
<NDC11Code>11701-0052-05</NDC11Code>
<ProductNDC>11701-052</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bedside-care Foam</ProprietaryName>
<ProprietaryNameSuffix>(alcohol Free)</ProprietaryNameSuffix>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Coloplast Corp</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Protects against the risk of bacterial contamination in minor cuts, scraps and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11701-053-05</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, SPRAY (11701-053-05) </PackageDescription>
<NDC11Code>11701-0053-05</NDC11Code>
<ProductNDC>11701-053</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bedside-care</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Coloplast Corp</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Protects against the risk of bacterial contamination in minor cuts, scraps and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0110-8</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (11822-0110-8) </PackageDescription>
<NDC11Code>11822-0110-08</NDC11Code>
<ProductNDC>11822-0110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peptic Relief</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090603</StartMarketingDate>
<EndMarketingDate>20191230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090603</StartMarketingDatePackage>
<EndMarketingDatePackage>20191230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11822-0413-8</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (11822-0413-8) </PackageDescription>
<NDC11Code>11822-0413-08</NDC11Code>
<ProductNDC>11822-0413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Original</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090716</StartMarketingDate>
<EndMarketingDate>20191230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090716</StartMarketingDatePackage>
<EndMarketingDatePackage>20191230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15127-085-08</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (15127-085-08) > 237 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>15127-0085-08</NDC11Code>
<ProductNDC>15127-085</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Cough And Chest Congestion Dm</ProprietaryName>
<ProprietaryNameSuffix>Adult</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150331</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Select Brand Dist.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 200</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150331</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15127-344-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (15127-344-08) </PackageDescription>
<NDC11Code>15127-0344-08</NDC11Code>
<ProductNDC>15127-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161031</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Select Brand Dist.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161031</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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