{
"NDC": [
{
"NDCCode": "47781-136-34",
"PackageDescription": "1 VIAL in 1 CARTON (47781-136-34) > 10 mL in 1 VIAL",
"NDC11Code": "47781-0136-34",
"ProductNDC": "47781-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution",
"ProprietaryNameSuffix": "Sterile Ophthalmic Solution",
"NonProprietaryName": "Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091180",
"LabelerName": "ALVOGEN INC.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "22.3; 6.8",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "47781-135-34",
"PackageDescription": "1 VIAL in 1 CARTON (47781-135-34) > 10 mL in 1 VIAL",
"NDC11Code": "47781-0135-34",
"ProductNDC": "47781-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml",
"ProprietaryNameSuffix": "Ophthalmic Solution 2%, 10ml",
"NonProprietaryName": "Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091034",
"LabelerName": "ALVOGEN INC.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
"StrengthNumber": "22.3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "46122-136-34",
"PackageDescription": "237 mL in 1 BOTTLE (46122-136-34) ",
"NDC11Code": "46122-0136-34",
"ProductNDC": "46122-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Night Time",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110828",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 minor aches and pains, 2 headache, 3 fever, 4 sore throat, 5 runny nose and sneezing, 6 cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "69339-136-34",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (69339-136-34) / 2 mL in 1 SYRINGE, GLASS (69339-136-03) ",
"NDC11Code": "69339-0136-34",
"ProductNDC": "69339-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210363",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.",
"Description": "Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative."
},
{
"NDCCode": "83711-136-12",
"PackageDescription": "34 g in 1 APPLICATOR (83711-136-12) ",
"NDC11Code": "83711-0136-12",
"ProductNDC": "83711-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Suave Invisible Solid Antiperspirant Deodorant Sweet Pea And Violet",
"NonProprietaryName": "Antiperspirant Stick",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Evermark, LLC",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "18.2",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Use reduces underarm wetness."
},
{
"NDCCode": "47781-174-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-174-01) ",
"NDC11Code": "47781-0174-01",
"ProductNDC": "47781-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "1.25; 1.25; 1.25; 1.25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170728",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; \"on the go;\" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "47781-176-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-176-01) ",
"NDC11Code": "47781-0176-01",
"ProductNDC": "47781-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "2.5; 2.5; 2.5; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170728",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; \"on the go;\" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "47781-178-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-178-01) ",
"NDC11Code": "47781-0178-01",
"ProductNDC": "47781-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "3.75; 3.75; 3.75; 3.75",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170728",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; \"on the go;\" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "47781-179-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-179-01) ",
"NDC11Code": "47781-0179-01",
"ProductNDC": "47781-179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170728",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; \"on the go;\" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "47781-180-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-180-01) ",
"NDC11Code": "47781-0180-01",
"ProductNDC": "47781-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170728",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; \"on the go;\" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "47781-304-03",
"PackageDescription": "30 POUCH in 1 CARTON (47781-304-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-304-11) ",
"NDC11Code": "47781-0304-03",
"ProductNDC": "47781-304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Transdermal System",
"NonProprietaryName": "Rivastigmine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204403",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "4.6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150904",
"SamplePackage": "N",
"Description": "Rivastigmine Transdermal System contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine Transdermal System is for transdermal administration. The patch comprises a multi-layer laminate containing the coversheet, backing film, reservoir layer, adhesive layer, and release liner as described below. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration. : 1 a cover sheet: siliconised polyethylene terephthalate film, 2 a backing film: Polyethylene / thermoplastic resin / aluminum coated polyester film, 3 an active reservoir layer containing the active pharmaceutical ingredient, 4 an adhesive matrix layer, 5 a release liner: fluoropolymer coated polyester film."
},
{
"NDCCode": "47781-305-03",
"PackageDescription": "30 POUCH in 1 CARTON (47781-305-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-305-11) ",
"NDC11Code": "47781-0305-03",
"ProductNDC": "47781-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Transdermal System",
"NonProprietaryName": "Rivastigmine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204403",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "9.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150904",
"SamplePackage": "N",
"Description": "Rivastigmine Transdermal System contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine Transdermal System is for transdermal administration. The patch comprises a multi-layer laminate containing the coversheet, backing film, reservoir layer, adhesive layer, and release liner as described below. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration. : 1 a cover sheet: siliconised polyethylene terephthalate film, 2 a backing film: Polyethylene / thermoplastic resin / aluminum coated polyester film, 3 an active reservoir layer containing the active pharmaceutical ingredient, 4 an adhesive matrix layer, 5 a release liner: fluoropolymer coated polyester film."
},
{
"NDCCode": "47781-405-03",
"PackageDescription": "30 POUCH in 1 CARTON (47781-405-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-405-11) ",
"NDC11Code": "47781-0405-03",
"ProductNDC": "47781-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Transdermal System",
"NonProprietaryName": "Rivastigmine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150902",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204403",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "13.3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150902",
"SamplePackage": "N",
"Description": "Rivastigmine Transdermal System contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine Transdermal System is for transdermal administration. The patch comprises a multi-layer laminate containing the coversheet, backing film, reservoir layer, adhesive layer, and release liner as described below. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration. : 1 a cover sheet: siliconised polyethylene terephthalate film, 2 a backing film: Polyethylene / thermoplastic resin / aluminum coated polyester film, 3 an active reservoir layer containing the active pharmaceutical ingredient, 4 an adhesive matrix layer, 5 a release liner: fluoropolymer coated polyester film."
},
{
"NDCCode": "47781-562-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-562-01) ",
"NDC11Code": "47781-0562-01",
"ProductNDC": "47781-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214547",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg)."
},
{
"NDCCode": "47781-563-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-563-01) ",
"NDC11Code": "47781-0563-01",
"ProductNDC": "47781-563",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214547",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg)."
},
{
"NDCCode": "47781-564-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-564-01) ",
"NDC11Code": "47781-0564-01",
"ProductNDC": "47781-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214547",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg)."
},
{
"NDCCode": "47781-565-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-565-01) ",
"NDC11Code": "47781-0565-01",
"ProductNDC": "47781-565",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214547",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg)."
},
{
"NDCCode": "47781-566-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-566-01) ",
"NDC11Code": "47781-0566-01",
"ProductNDC": "47781-566",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214547",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg)."
},
{
"NDCCode": "47781-567-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-567-01) ",
"NDC11Code": "47781-0567-01",
"ProductNDC": "47781-567",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214547",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg)."
},
{
"NDCCode": "47781-568-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-568-01) ",
"NDC11Code": "47781-0568-01",
"ProductNDC": "47781-568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214547",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg)."
},
{
"NDCCode": "47781-652-89",
"PackageDescription": "1 SYRINGE in 1 CARTON (47781-652-89) / 2.24 mL in 1 SYRINGE",
"NDC11Code": "47781-0652-89",
"ProductNDC": "47781-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriparatide",
"NonProprietaryName": "Teriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211939",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "TERIPARATIDE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2026-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191114",
"SamplePackage": "N",
"IndicationAndUsage": "Teriparatide injection is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.",
"Description": "Teriparatide injection is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N‑terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below:. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. Teriparatide injection is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times."
},
{
"NDCCode": "47781-683-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (47781-683-30) ",
"NDC11Code": "47781-0683-30",
"ProductNDC": "47781-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rasagiline",
"NonProprietaryName": "Rasagiline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201970",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "RASAGILINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).",
"Description": "Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine,2,3-dihydro-N-2-propynyl-,(1R)-,methanesulfonate. The molecular formula of rasagiline mesylate is C12H13NCH4SO3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate). Each rasagiline tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, corn starch, talc, stearic acid, and citric acid monohydrate."
},
{
"NDCCode": "47781-690-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (47781-690-30) ",
"NDC11Code": "47781-0690-30",
"ProductNDC": "47781-690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rasagiline",
"NonProprietaryName": "Rasagiline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201970",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "RASAGILINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).",
"Description": "Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine,2,3-dihydro-N-2-propynyl-,(1R)-,methanesulfonate. The molecular formula of rasagiline mesylate is C12H13NCH4SO3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate). Each rasagiline tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, corn starch, talc, stearic acid, and citric acid monohydrate."
},
{
"NDCCode": "47781-729-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (47781-729-02) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "47781-0729-02",
"ProductNDC": "47781-729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120409",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065490",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120409",
"EndMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula."
},
{
"NDCCode": "47781-729-50",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (47781-729-50) ",
"NDC11Code": "47781-0729-50",
"ProductNDC": "47781-729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120409",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065490",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120409",
"EndMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula."
},
{
"NDCCode": "47781-730-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (47781-730-02) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "47781-0730-02",
"ProductNDC": "47781-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120409",
"EndMarketingDate": "20240901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065490",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120409",
"EndMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula."
},
{
"NDCCode": "47781-730-50",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (47781-730-50) ",
"NDC11Code": "47781-0730-50",
"ProductNDC": "47781-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120409",
"EndMarketingDate": "20240901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065490",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120409",
"EndMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula."
},
{
"NDCCode": "47781-852-89",
"PackageDescription": "1 SYRINGE in 1 CARTON (47781-852-89) / 2.24 mL in 1 SYRINGE",
"NDC11Code": "47781-0852-89",
"ProductNDC": "47781-852",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonsity",
"NonProprietaryName": "Teriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250606",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211939",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "TERIPARATIDE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2026-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250606",
"SamplePackage": "N",
"IndicationAndUsage": "BONSITY is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BONSITY reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.",
"Description": "BONSITY (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. BONSITY is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times."
},
{
"NDCCode": "11523-7297-1",
"PackageDescription": "177 mL in 1 BOTTLE, SPRAY (11523-7297-1)",
"NDC11Code": "11523-7297-01",
"ProductNDC": "11523-7297",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coppertone Sport",
"ProprietaryNameSuffix": "Spf 90",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990521",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Schering-Plough HealthCare Products, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "27.34; 136.68; 45.56; 91.12; 54.67",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "54868-6435-0",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (54868-6435-0)",
"NDC11Code": "54868-6435-00",
"ProductNDC": "54868-6435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenpep",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140912",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022210",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
"StrengthNumber": "10000; 34000; 55000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ZENPEP® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.",
"Description": "ZENPEP is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine derived lipases, proteases, and amylases. Pancrelipase is a cream-colored powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether. Each capsule for oral administration contains enteric-coated beads (1.8-1.9mm for 3,000 and 5,000 USP units of lipase, 2.2-2.5mm for 10,000, 15,000, 20,000 and 25,000 USP units of lipase). The active ingredient evaluated in clinical trials is lipase. ZENPEP is dosed by lipase units. Other active ingredients include protease and amylase. Inactive ingredients in ZENPEP include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate and are contained in hypromellose capsules. The imprinting red ink on the 3,000 capsules strength contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I. 77491-E172, n-butyl alcohol, shellac and soya lecithin. 3,000 USP units of lipase; 10,000 USP units of protease; 16,000 USP units of amylase. Capsules have a white opaque cap and a white opaque body with imprint “EURAND 3”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The imprinting blue ink on the capsules strengths 5,000, 10,000, 15,000, 20,000 and 25,000 contains dehydrated alcohol, FD&C Blue #2 aluminum lake C.I. 73015-E132, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and strong ammonia solution. 5,000 USP units of lipase; 17,000 USP units of protease; 27,000 USP units of amylase. Capsules have a white opaque cap and a white opaque body with imprint “EURAND 5”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. 10,000 USP units of lipase; 34,000 USP units of protease; 55,000 USP units of amylase. Capsules have a yellow opaque cap and a white opaque body with imprint “EURAND 10”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. 15,000 USP units of lipase; 51,000 USP units of protease; 82,000 USP units of amylase. Capsules have a red opaque cap and a white opaque body with imprint “EURAND 15”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. 20,000 USP units of lipase; 68,000 USP units of protease; 109,000 USP units of amylase. Capsules have a green opaque cap and a white opaque body with imprint “EURAND 20”. The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. 25,000 USP units of lipase; 85,000 USP units of protease; 136,000 USP units of amylase. Capsules have a blue opaque cap and a white opaque body with imprint “EURAND 25”. The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>47781-136-34</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (47781-136-34) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>47781-0136-34</NDC11Code>
<ProductNDC>47781-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution</ProprietaryName>
<ProprietaryNameSuffix>Sterile Ophthalmic Solution</ProprietaryNameSuffix>
<NonProprietaryName>Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091180</ApplicationNumber>
<LabelerName>ALVOGEN INC.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>22.3; 6.8</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-135-34</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (47781-135-34) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>47781-0135-34</NDC11Code>
<ProductNDC>47781-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml</ProprietaryName>
<ProprietaryNameSuffix>Ophthalmic Solution 2%, 10ml</ProprietaryNameSuffix>
<NonProprietaryName>Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091034</ApplicationNumber>
<LabelerName>ALVOGEN INC.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>22.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46122-136-34</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (46122-136-34) </PackageDescription>
<NDC11Code>46122-0136-34</NDC11Code>
<ProductNDC>46122-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Night Time</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110828</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 minor aches and pains, 2 headache, 3 fever, 4 sore throat, 5 runny nose and sneezing, 6 cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69339-136-34</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (69339-136-34) / 2 mL in 1 SYRINGE, GLASS (69339-136-03) </PackageDescription>
<NDC11Code>69339-0136-34</NDC11Code>
<ProductNDC>69339-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210363</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative.</Description>
</NDC>
<NDC>
<NDCCode>83711-136-12</NDCCode>
<PackageDescription>34 g in 1 APPLICATOR (83711-136-12) </PackageDescription>
<NDC11Code>83711-0136-12</NDC11Code>
<ProductNDC>83711-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Suave Invisible Solid Antiperspirant Deodorant Sweet Pea And Violet</ProprietaryName>
<NonProprietaryName>Antiperspirant Stick</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Evermark, LLC</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>18.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47781-174-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-174-01) </PackageDescription>
<NDC11Code>47781-0174-01</NDC11Code>
<ProductNDC>47781-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.25; 1.25; 1.25; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>47781-176-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-176-01) </PackageDescription>
<NDC11Code>47781-0176-01</NDC11Code>
<ProductNDC>47781-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>47781-178-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-178-01) </PackageDescription>
<NDC11Code>47781-0178-01</NDC11Code>
<ProductNDC>47781-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.75; 3.75; 3.75; 3.75</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>47781-179-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-179-01) </PackageDescription>
<NDC11Code>47781-0179-01</NDC11Code>
<ProductNDC>47781-179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5; 5; 5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>47781-180-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-180-01) </PackageDescription>
<NDC11Code>47781-0180-01</NDC11Code>
<ProductNDC>47781-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. a 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as suppliedb 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as suppliedc 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as suppliedd 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied e 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as suppliedf 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as suppliedg 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg is a white tablet, which contains no color additives. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>47781-304-03</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (47781-304-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-304-11) </PackageDescription>
<NDC11Code>47781-0304-03</NDC11Code>
<ProductNDC>47781-304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Transdermal System</ProprietaryName>
<NonProprietaryName>Rivastigmine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204403</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>4.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Rivastigmine Transdermal System contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine Transdermal System is for transdermal administration. The patch comprises a multi-layer laminate containing the coversheet, backing film, reservoir layer, adhesive layer, and release liner as described below. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration. : 1 a cover sheet: siliconised polyethylene terephthalate film, 2 a backing film: Polyethylene / thermoplastic resin / aluminum coated polyester film, 3 an active reservoir layer containing the active pharmaceutical ingredient, 4 an adhesive matrix layer, 5 a release liner: fluoropolymer coated polyester film.</Description>
</NDC>
<NDC>
<NDCCode>47781-305-03</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (47781-305-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-305-11) </PackageDescription>
<NDC11Code>47781-0305-03</NDC11Code>
<ProductNDC>47781-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Transdermal System</ProprietaryName>
<NonProprietaryName>Rivastigmine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204403</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>9.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Rivastigmine Transdermal System contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine Transdermal System is for transdermal administration. The patch comprises a multi-layer laminate containing the coversheet, backing film, reservoir layer, adhesive layer, and release liner as described below. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration. : 1 a cover sheet: siliconised polyethylene terephthalate film, 2 a backing film: Polyethylene / thermoplastic resin / aluminum coated polyester film, 3 an active reservoir layer containing the active pharmaceutical ingredient, 4 an adhesive matrix layer, 5 a release liner: fluoropolymer coated polyester film.</Description>
</NDC>
<NDC>
<NDCCode>47781-405-03</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (47781-405-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-405-11) </PackageDescription>
<NDC11Code>47781-0405-03</NDC11Code>
<ProductNDC>47781-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Transdermal System</ProprietaryName>
<NonProprietaryName>Rivastigmine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150902</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204403</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>13.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Rivastigmine Transdermal System contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine Transdermal System is for transdermal administration. The patch comprises a multi-layer laminate containing the coversheet, backing film, reservoir layer, adhesive layer, and release liner as described below. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration. : 1 a cover sheet: siliconised polyethylene terephthalate film, 2 a backing film: Polyethylene / thermoplastic resin / aluminum coated polyester film, 3 an active reservoir layer containing the active pharmaceutical ingredient, 4 an adhesive matrix layer, 5 a release liner: fluoropolymer coated polyester film.</Description>
</NDC>
<NDC>
<NDCCode>47781-562-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-562-01) </PackageDescription>
<NDC11Code>47781-0562-01</NDC11Code>
<ProductNDC>47781-562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214547</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg).</Description>
</NDC>
<NDC>
<NDCCode>47781-563-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-563-01) </PackageDescription>
<NDC11Code>47781-0563-01</NDC11Code>
<ProductNDC>47781-563</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214547</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg).</Description>
</NDC>
<NDC>
<NDCCode>47781-564-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-564-01) </PackageDescription>
<NDC11Code>47781-0564-01</NDC11Code>
<ProductNDC>47781-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214547</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg).</Description>
</NDC>
<NDC>
<NDCCode>47781-565-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-565-01) </PackageDescription>
<NDC11Code>47781-0565-01</NDC11Code>
<ProductNDC>47781-565</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214547</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg).</Description>
</NDC>
<NDC>
<NDCCode>47781-566-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-566-01) </PackageDescription>
<NDC11Code>47781-0566-01</NDC11Code>
<ProductNDC>47781-566</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214547</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg).</Description>
</NDC>
<NDC>
<NDCCode>47781-567-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-567-01) </PackageDescription>
<NDC11Code>47781-0567-01</NDC11Code>
<ProductNDC>47781-567</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214547</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg).</Description>
</NDC>
<NDC>
<NDCCode>47781-568-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-568-01) </PackageDescription>
<NDC11Code>47781-0568-01</NDC11Code>
<ProductNDC>47781-568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214547</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for Lisdexamfetamine Dimesylate Capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: black iron oxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, and titanium dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg, 30 mg, 60 mg, and 70 mg), FD&C Red #40 (40 mg), and D&C Yellow #10 (30 mg and 70 mg).</Description>
</NDC>
<NDC>
<NDCCode>47781-652-89</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (47781-652-89) / 2.24 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>47781-0652-89</NDC11Code>
<ProductNDC>47781-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriparatide</ProprietaryName>
<NonProprietaryName>Teriparatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211939</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>TERIPARATIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriparatide injection is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.</IndicationAndUsage>
<Description>Teriparatide injection is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N‑terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below:. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. Teriparatide injection is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times.</Description>
</NDC>
<NDC>
<NDCCode>47781-683-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (47781-683-30) </PackageDescription>
<NDC11Code>47781-0683-30</NDC11Code>
<ProductNDC>47781-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasagiline</ProprietaryName>
<NonProprietaryName>Rasagiline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201970</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>RASAGILINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).</IndicationAndUsage>
<Description>Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine,2,3-dihydro-N-2-propynyl-,(1R)-,methanesulfonate. The molecular formula of rasagiline mesylate is C12H13NCH4SO3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate). Each rasagiline tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, corn starch, talc, stearic acid, and citric acid monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>47781-690-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (47781-690-30) </PackageDescription>
<NDC11Code>47781-0690-30</NDC11Code>
<ProductNDC>47781-690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasagiline</ProprietaryName>
<NonProprietaryName>Rasagiline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201970</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>RASAGILINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).</IndicationAndUsage>
<Description>Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine,2,3-dihydro-N-2-propynyl-,(1R)-,methanesulfonate. The molecular formula of rasagiline mesylate is C12H13NCH4SO3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate). Each rasagiline tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, corn starch, talc, stearic acid, and citric acid monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>47781-729-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (47781-729-02) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47781-0729-02</NDC11Code>
<ProductNDC>47781-729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120409</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065490</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120409</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47781-729-50</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (47781-729-50) </PackageDescription>
<NDC11Code>47781-0729-50</NDC11Code>
<ProductNDC>47781-729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120409</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065490</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120409</StartMarketingDatePackage>
<EndMarketingDatePackage>20240901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47781-730-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (47781-730-02) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47781-0730-02</NDC11Code>
<ProductNDC>47781-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120409</StartMarketingDate>
<EndMarketingDate>20240901</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065490</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120409</StartMarketingDatePackage>
<EndMarketingDatePackage>20240901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47781-730-50</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (47781-730-50) </PackageDescription>
<NDC11Code>47781-0730-50</NDC11Code>
<ProductNDC>47781-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120409</StartMarketingDate>
<EndMarketingDate>20240901</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065490</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120409</StartMarketingDatePackage>
<EndMarketingDatePackage>20240901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use. Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections. Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&C Blue No. 1, D & C Red No. 28, D & C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47781-852-89</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (47781-852-89) / 2.24 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>47781-0852-89</NDC11Code>
<ProductNDC>47781-852</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonsity</ProprietaryName>
<NonProprietaryName>Teriparatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250606</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211939</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>TERIPARATIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BONSITY is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BONSITY reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.</IndicationAndUsage>
<Description>BONSITY (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and the molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide is manufactured using a strain of Pseudomonas fluorescens modified by recombinant DNA technology. BONSITY is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each pen is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg teriparatide (as a free base), 0.41 mg glacial acetic acid, 0.10 mg sodium acetate, 45.4 mg mannitol, 3 mg metacresol, and water for injection. The drug product is a pH 4.0 solution. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times.</Description>
</NDC>
<NDC>
<NDCCode>11523-7297-1</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, SPRAY (11523-7297-1)</PackageDescription>
<NDC11Code>11523-7297-01</NDC11Code>
<ProductNDC>11523-7297</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Sport</ProprietaryName>
<ProprietaryNameSuffix>Spf 90</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990521</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Schering-Plough HealthCare Products, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>27.34; 136.68; 45.56; 91.12; 54.67</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>54868-6435-0</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (54868-6435-0)</PackageDescription>
<NDC11Code>54868-6435-00</NDC11Code>
<ProductNDC>54868-6435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenpep</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140912</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022210</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE</SubstanceName>
<StrengthNumber>10000; 34000; 55000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ZENPEP® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.</IndicationAndUsage>
<Description>ZENPEP is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine derived lipases, proteases, and amylases. Pancrelipase is a cream-colored powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether. Each capsule for oral administration contains enteric-coated beads (1.8-1.9mm for 3,000 and 5,000 USP units of lipase, 2.2-2.5mm for 10,000, 15,000, 20,000 and 25,000 USP units of lipase). The active ingredient evaluated in clinical trials is lipase. ZENPEP is dosed by lipase units. Other active ingredients include protease and amylase. Inactive ingredients in ZENPEP include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate and are contained in hypromellose capsules. The imprinting red ink on the 3,000 capsules strength contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I. 77491-E172, n-butyl alcohol, shellac and soya lecithin. 3,000 USP units of lipase; 10,000 USP units of protease; 16,000 USP units of amylase. Capsules have a white opaque cap and a white opaque body with imprint “EURAND 3”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The imprinting blue ink on the capsules strengths 5,000, 10,000, 15,000, 20,000 and 25,000 contains dehydrated alcohol, FD&C Blue #2 aluminum lake C.I. 73015-E132, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and strong ammonia solution. 5,000 USP units of lipase; 17,000 USP units of protease; 27,000 USP units of amylase. Capsules have a white opaque cap and a white opaque body with imprint “EURAND 5”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. 10,000 USP units of lipase; 34,000 USP units of protease; 55,000 USP units of amylase. Capsules have a yellow opaque cap and a white opaque body with imprint “EURAND 10”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. 15,000 USP units of lipase; 51,000 USP units of protease; 82,000 USP units of amylase. Capsules have a red opaque cap and a white opaque body with imprint “EURAND 15”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. 20,000 USP units of lipase; 68,000 USP units of protease; 109,000 USP units of amylase. Capsules have a green opaque cap and a white opaque body with imprint “EURAND 20”. The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. 25,000 USP units of lipase; 85,000 USP units of protease; 136,000 USP units of amylase. Capsules have a blue opaque cap and a white opaque body with imprint “EURAND 25”. The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water.</Description>
</NDC>
</NDCList>