{
"NDC": [
{
"NDCCode": "72516-015-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72516-015-01) ",
"NDC11Code": "72516-0015-01",
"ProductNDC": "72516-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210293",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "1.875; 1.875; 1.875; 1.875",
"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": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201019",
"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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72516-011-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72516-011-01) ",
"NDC11Code": "72516-0011-01",
"ProductNDC": "72516-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210293",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201019",
"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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72516-012-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72516-012-01) ",
"NDC11Code": "72516-0012-01",
"ProductNDC": "72516-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210293",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201019",
"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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72516-013-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72516-013-01) ",
"NDC11Code": "72516-0013-01",
"ProductNDC": "72516-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210293",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201019",
"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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72516-014-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72516-014-01) ",
"NDC11Code": "72516-0014-01",
"ProductNDC": "72516-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210293",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201019",
"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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72516-016-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72516-016-01) ",
"NDC11Code": "72516-0016-01",
"ProductNDC": "72516-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210293",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201019",
"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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive."
},
{
"NDCCode": "72516-020-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-020-01) ",
"NDC11Code": "72516-0020-01",
"ProductNDC": "72516-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212948",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260518",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2.Generalized tonic-clonic seizures (grand mal). 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 200 and 400 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients:Hypromellose, hydroxyethyl cellulose, cellulose acetate, mannitol, dextrates, sodium lauryl sulfate, magnesium stearate, polyethylene glycol 400, polyethylene glycol 8000, opacode S-1-17823 black ink (contains: shellac glaze, iron oxide black, propylene glycol, ammonium hydroxide 28%). FDA approved dissolution method differs from that of the USP."
},
{
"NDCCode": "72516-021-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-021-01) ",
"NDC11Code": "72516-0021-01",
"ProductNDC": "72516-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212948",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260518",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2.Generalized tonic-clonic seizures (grand mal). 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 200 and 400 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients:Hypromellose, hydroxyethyl cellulose, cellulose acetate, mannitol, dextrates, sodium lauryl sulfate, magnesium stearate, polyethylene glycol 400, polyethylene glycol 8000, opacode S-1-17823 black ink (contains: shellac glaze, iron oxide black, propylene glycol, ammonium hydroxide 28%). FDA approved dissolution method differs from that of the USP."
},
{
"NDCCode": "72516-025-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 PACKAGE (72516-025-01) ",
"NDC11Code": "72516-0025-01",
"ProductNDC": "72516-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214110",
"LabelerName": "Oryza pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260515",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72516-026-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-026-01) ",
"NDC11Code": "72516-0026-01",
"ProductNDC": "72516-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214110",
"LabelerName": "Oryza pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250721",
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"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72516-027-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-027-01) ",
"NDC11Code": "72516-0027-01",
"ProductNDC": "72516-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214110",
"LabelerName": "Oryza pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250721",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72516-028-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-028-01) ",
"NDC11Code": "72516-0028-01",
"ProductNDC": "72516-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214110",
"LabelerName": "Oryza pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250721",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72516-029-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (72516-029-01) / 60 mL in 1 BOTTLE, GLASS",
"NDC11Code": "72516-0029-01",
"ProductNDC": "72516-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate For Oral Suspension",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20251019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217303",
"LabelerName": "Oryza Pharmaceuticals Inc.",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251019",
"SamplePackage": "N",
"Description": "Oseltamivir phosphate, USP, an influenza neuraminidase inhibitor (NAI), is available as a powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum. Oseltamivir Phosphate, USP is a white to off-white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16H 28N 2O 4(free base). The molecular weight is 312.4 for Oseltamivir free base and 410.4 for Oseltamivir Phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "72516-030-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-030-01) ",
"NDC11Code": "72516-0030-01",
"ProductNDC": "72516-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "Oryza Pharmaceuticals, Inc",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220427",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin."
},
{
"NDCCode": "72516-031-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-01) ",
"NDC11Code": "72516-0031-01",
"ProductNDC": "72516-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "Oryza Pharmaceuticals, Inc",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220427",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin."
},
{
"NDCCode": "72516-032-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-032-01) ",
"NDC11Code": "72516-0032-01",
"ProductNDC": "72516-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "Oryza Pharmaceuticals, Inc",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220427",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin."
},
{
"NDCCode": "72516-033-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-033-01) ",
"NDC11Code": "72516-0033-01",
"ProductNDC": "72516-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "Oryza Pharmaceuticals, Inc",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220427",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin."
},
{
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"PackageDescription": "1 TUBE in 1 CARTON (10348-015-01) > 30 mL in 1 TUBE",
"NDC11Code": "10348-0015-01",
"ProductNDC": "10348-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camera Ready Bb Broad Spectrum Spf 35",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".078; .0416; .026; .0114",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N"
},
{
"NDCCode": "11559-015-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (11559-015-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "11559-0015-01",
"ProductNDC": "11559-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daywear Bb",
"ProprietaryNameSuffix": "Anti Oxidant Beauty Benefit Broad Spectrum Spf 35",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": "7.5; 4; 2.5; 1.1",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "11788-015-01",
"PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (11788-015-01) ",
"NDC11Code": "11788-0015-01",
"ProductNDC": "11788-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Docusate Sodium",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "AiPing Pharmaceutical, Inc.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-05-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N"
},
{
"NDCCode": "11994-015-01",
"PackageDescription": "25 mL in 1 VIAL, MULTI-DOSE (11994-015-01) ",
"NDC11Code": "11994-0015-01",
"ProductNDC": "11994-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fludeoxyglucose F-18",
"NonProprietaryName": "Fludeoxyglucose F-18",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203664",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "FLUDEOXYGLUCOSE F-18",
"StrengthNumber": "200",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140204",
"SamplePackage": "N"
},
{
"NDCCode": "13107-015-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-015-01) ",
"NDC11Code": "13107-0015-01",
"ProductNDC": "13107-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202675",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230228",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "13733-015-01",
"PackageDescription": "11 g in 1 CARTON (13733-015-01)",
"NDC11Code": "13733-0015-01",
"ProductNDC": "13733-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha Signature Dramatic Whitening Pact",
"ProprietaryNameSuffix": "No.2 Spf50 Plus Pa Plus Plus Plus",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ABLE C&C CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "1.84; .66; .32",
"StrengthUnit": "g/11g; g/11g; g/11g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INDICATION AND USAGE:After using foundation or BB cream, take an appropriate amount with encased puff and apply it evenly and lightly on face."
},
{
"NDCCode": "14141-015-01",
"PackageDescription": "1 CASE in 1 BOX (14141-015-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0015-01",
"ProductNDC": "14141-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 320-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "75; 78.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "14445-015-01",
"PackageDescription": ".1 kg in 1 DRUM (14445-015-01) ",
"NDC11Code": "14445-0015-01",
"ProductNDC": "14445-015",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Neostigmine Methylsulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161130",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "NEOSTIGMINE METHYLSULFATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-19",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "30-NOV-16"
},
{
"NDCCode": "14474-015-01",
"PackageDescription": "25 kg in 1 CONTAINER (14474-015-01)",
"NDC11Code": "14474-0015-01",
"ProductNDC": "14474-015",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Latanoprost",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sai Life Sciences Limited",
"SubstanceName": "LATANOPROST",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "14783-015-01",
"PackageDescription": "1 g in 1 PACKET (14783-015-01)",
"NDC11Code": "14783-0015-01",
"ProductNDC": "14783-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Lederm 35plus Jour",
"ProprietaryNameSuffix": "Spf 15 Facial Treatment Against First Signs Of Aging Day - Normal To Dry Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .05; .03; .05",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-015-01",
"PackageDescription": "1 VIAL in 1 CARTON (16714-015-01) > 10 mL in 1 VIAL",
"NDC11Code": "16714-0015-01",
"ProductNDC": "16714-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091280",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.Desmopressin acetate injection will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.Desmopressin acetate injection will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. In certain clinical situations, it may be justified to try desmopressin acetate injection in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.von Willebrand’s Disease (Type I): Desmopressin acetate injection 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrand’s disease (Type I) with factor VIII levels greater than 5%. Desmopressin acetate injection will often maintain hemostasis in patients with mild to moderate von Willebrand’s disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.Desmopressin acetate injection will usually stop bleeding in mild to moderate von Willebrand’s patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.Those von Willebrand’s disease patients who are least likely to respond are those with severe homozygous von Willebrand’s disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of desmopressin acetate injection to ensure that adequate levels are being achieved.Desmopressin acetate injection is not indicated for the treatment of severe classic von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. (See WARNINGS.)Diabetes Insipidus: Desmopressin acetate injection 4 mcg/mL is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate injection is ineffective for the treatment of nephrogenic diabetes insipidus.Desmopressin acetate is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.",
"Description": "Desmopressin acetate. injection, USP 4 mcg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:Mol. Wt. 1069.23Molecular Formula: C46H64N14O12S2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin acetate.Desmopressin acetate. Injection, USP 4 mcg/mL is provided as a sterile, aqueous solution for injection.Each mL provides:Desmopressin acetate, USP, 4 mcgSodium chloride, 9 mgHydrochloric acid to adjust pH to 4Water for injection, q.s. to 1 mLThe 10 mL vial contains chlorobutanol as a preservative (5 mg/mL)."
},
{
"NDCCode": "17333-015-01",
"PackageDescription": "50 kg in 1 DRUM (17333-015-01)",
"NDC11Code": "17333-0015-01",
"ProductNDC": "17333-015",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Glycine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20141220",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Ajinomoto Co., Inc.",
"SubstanceName": "GLYCINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "22100-015-01",
"PackageDescription": "236 g in 1 BOTTLE (22100-015-01)",
"NDC11Code": "22100-0015-01",
"ProductNDC": "22100-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healing Waters Cucumber Melon Scented Anti-bacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110507",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "NINGBO MEIDUO GENERAL PRODUCTS CO., LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses: To decrease bacteria on the skin that could cause diseases. Recommended for repeated use."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72516-015-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72516-015-01) </PackageDescription>
<NDC11Code>72516-0015-01</NDC11Code>
<ProductNDC>72516-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210293</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.875; 1.875; 1.875; 1.875</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>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201019</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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72516-011-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72516-011-01) </PackageDescription>
<NDC11Code>72516-0011-01</NDC11Code>
<ProductNDC>72516-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210293</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201019</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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72516-012-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72516-012-01) </PackageDescription>
<NDC11Code>72516-0012-01</NDC11Code>
<ProductNDC>72516-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210293</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201019</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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72516-013-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72516-013-01) </PackageDescription>
<NDC11Code>72516-0013-01</NDC11Code>
<ProductNDC>72516-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210293</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201019</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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive.</Description>
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<NDC>
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<ApplicationNumber>ANDA210293</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE 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>
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<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
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<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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72516-016-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72516-016-01) </PackageDescription>
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<ProductNDC>72516-016</ProductNDC>
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<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
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<StartMarketingDate>20201019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210293</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
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<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>2026-08-12</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201019</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 monohydrate. Inactive Ingredients: silicified microcrystalline cellulose, partially pregelatinized maize starch and magnesium stearate. Colors: The 5 mg, 7.5 mg and 10 mg contain FD&C Blue No 1 Aluminum Lake as a color additive. The 15 mg, 20 mg and 30 mg contain FD&C Yellow No 6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>72516-020-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-020-01) </PackageDescription>
<NDC11Code>72516-0020-01</NDC11Code>
<ProductNDC>72516-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212948</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2.Generalized tonic-clonic seizures (grand mal). 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 200 and 400 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients:Hypromellose, hydroxyethyl cellulose, cellulose acetate, mannitol, dextrates, sodium lauryl sulfate, magnesium stearate, polyethylene glycol 400, polyethylene glycol 8000, opacode S-1-17823 black ink (contains: shellac glaze, iron oxide black, propylene glycol, ammonium hydroxide 28%). FDA approved dissolution method differs from that of the USP.</Description>
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<NDC>
<NDCCode>72516-021-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-021-01) </PackageDescription>
<NDC11Code>72516-0021-01</NDC11Code>
<ProductNDC>72516-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212948</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2.Generalized tonic-clonic seizures (grand mal). 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 200 and 400 mg. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients:Hypromellose, hydroxyethyl cellulose, cellulose acetate, mannitol, dextrates, sodium lauryl sulfate, magnesium stearate, polyethylene glycol 400, polyethylene glycol 8000, opacode S-1-17823 black ink (contains: shellac glaze, iron oxide black, propylene glycol, ammonium hydroxide 28%). FDA approved dissolution method differs from that of the USP.</Description>
</NDC>
<NDC>
<NDCCode>72516-025-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 PACKAGE (72516-025-01) </PackageDescription>
<NDC11Code>72516-0025-01</NDC11Code>
<ProductNDC>72516-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214110</ApplicationNumber>
<LabelerName>Oryza pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
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<NDCCode>72516-026-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-026-01) </PackageDescription>
<NDC11Code>72516-0026-01</NDC11Code>
<ProductNDC>72516-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214110</ApplicationNumber>
<LabelerName>Oryza pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
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<NDC11Code>72516-0027-01</NDC11Code>
<ProductNDC>72516-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<ApplicationNumber>ANDA214110</ApplicationNumber>
<LabelerName>Oryza pharmaceuticals Inc.</LabelerName>
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<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
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<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-028-01) </PackageDescription>
<NDC11Code>72516-0028-01</NDC11Code>
<ProductNDC>72516-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214110</ApplicationNumber>
<LabelerName>Oryza pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72516-029-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (72516-029-01) / 60 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>72516-0029-01</NDC11Code>
<ProductNDC>72516-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate For Oral Suspension</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217303</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Oseltamivir phosphate, USP, an influenza neuraminidase inhibitor (NAI), is available as a powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum. Oseltamivir Phosphate, USP is a white to off-white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16H 28N 2O 4(free base). The molecular weight is 312.4 for Oseltamivir free base and 410.4 for Oseltamivir Phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>72516-030-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-030-01) </PackageDescription>
<NDC11Code>72516-0030-01</NDC11Code>
<ProductNDC>72516-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals, Inc</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.</Description>
</NDC>
<NDC>
<NDCCode>72516-031-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-01) </PackageDescription>
<NDC11Code>72516-0031-01</NDC11Code>
<ProductNDC>72516-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals, Inc</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.</Description>
</NDC>
<NDC>
<NDCCode>72516-032-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-032-01) </PackageDescription>
<NDC11Code>72516-0032-01</NDC11Code>
<ProductNDC>72516-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals, Inc</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.</Description>
</NDC>
<NDC>
<NDCCode>72516-033-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-033-01) </PackageDescription>
<NDC11Code>72516-0033-01</NDC11Code>
<ProductNDC>72516-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>Oryza Pharmaceuticals, Inc</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.</Description>
</NDC>
<NDC>
<NDCCode>10348-015-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10348-015-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>10348-0015-01</NDC11Code>
<ProductNDC>10348-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camera Ready Bb Broad Spectrum Spf 35</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.078; .0416; .026; .0114</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11559-015-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11559-015-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11559-0015-01</NDC11Code>
<ProductNDC>11559-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daywear Bb</ProprietaryName>
<ProprietaryNameSuffix>Anti Oxidant Beauty Benefit Broad Spectrum Spf 35</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7.5; 4; 2.5; 1.1</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11788-015-01</NDCCode>
<PackageDescription>100 CAPSULE, LIQUID FILLED in 1 BOTTLE (11788-015-01) </PackageDescription>
<NDC11Code>11788-0015-01</NDC11Code>
<ProductNDC>11788-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Docusate Sodium</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11994-015-01</NDCCode>
<PackageDescription>25 mL in 1 VIAL, MULTI-DOSE (11994-015-01) </PackageDescription>
<NDC11Code>11994-0015-01</NDC11Code>
<ProductNDC>11994-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fludeoxyglucose F-18</ProprietaryName>
<NonProprietaryName>Fludeoxyglucose F-18</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203664</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>FLUDEOXYGLUCOSE F-18</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13107-015-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-015-01) </PackageDescription>
<NDC11Code>13107-0015-01</NDC11Code>
<ProductNDC>13107-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202675</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:. Each glycopyrrolate tablets, USP contains glycopyrrolate, USP 1 mg or 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>13733-015-01</NDCCode>
<PackageDescription>11 g in 1 CARTON (13733-015-01)</PackageDescription>
<NDC11Code>13733-0015-01</NDC11Code>
<ProductNDC>13733-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha Signature Dramatic Whitening Pact</ProprietaryName>
<ProprietaryNameSuffix>No.2 Spf50 Plus Pa Plus Plus Plus</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ABLE C&C CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.84; .66; .32</StrengthNumber>
<StrengthUnit>g/11g; g/11g; g/11g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INDICATION AND USAGE:After using foundation or BB cream, take an appropriate amount with encased puff and apply it evenly and lightly on face.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-015-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-015-01) > 9 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0015-01</NDC11Code>
<ProductNDC>14141-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 320-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 78.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14445-015-01</NDCCode>
<PackageDescription>.1 kg in 1 DRUM (14445-015-01) </PackageDescription>
<NDC11Code>14445-0015-01</NDC11Code>
<ProductNDC>14445-015</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Neostigmine Methylsulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161130</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>NEOSTIGMINE METHYLSULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-19</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-NOV-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14474-015-01</NDCCode>
<PackageDescription>25 kg in 1 CONTAINER (14474-015-01)</PackageDescription>
<NDC11Code>14474-0015-01</NDC11Code>
<ProductNDC>14474-015</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Latanoprost</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sai Life Sciences Limited</LabelerName>
<SubstanceName>LATANOPROST</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>14783-015-01</NDCCode>
<PackageDescription>1 g in 1 PACKET (14783-015-01)</PackageDescription>
<NDC11Code>14783-0015-01</NDC11Code>
<ProductNDC>14783-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Lederm 35plus Jour</ProprietaryName>
<ProprietaryNameSuffix>Spf 15 Facial Treatment Against First Signs Of Aging Day - Normal To Dry Skin</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .05; .03; .05</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-015-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (16714-015-01) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>16714-0015-01</NDC11Code>
<ProductNDC>16714-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091280</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.Desmopressin acetate injection will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.Desmopressin acetate injection will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. In certain clinical situations, it may be justified to try desmopressin acetate injection in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.von Willebrand’s Disease (Type I): Desmopressin acetate injection 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrand’s disease (Type I) with factor VIII levels greater than 5%. Desmopressin acetate injection will often maintain hemostasis in patients with mild to moderate von Willebrand’s disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.Desmopressin acetate injection will usually stop bleeding in mild to moderate von Willebrand’s patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.Those von Willebrand’s disease patients who are least likely to respond are those with severe homozygous von Willebrand’s disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of desmopressin acetate injection to ensure that adequate levels are being achieved.Desmopressin acetate injection is not indicated for the treatment of severe classic von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. (See WARNINGS.)Diabetes Insipidus: Desmopressin acetate injection 4 mcg/mL is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate injection is ineffective for the treatment of nephrogenic diabetes insipidus.Desmopressin acetate is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.</IndicationAndUsage>
<Description>Desmopressin acetate. injection, USP 4 mcg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:Mol. Wt. 1069.23Molecular Formula: C46H64N14O12S2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin acetate.Desmopressin acetate. Injection, USP 4 mcg/mL is provided as a sterile, aqueous solution for injection.Each mL provides:Desmopressin acetate, USP, 4 mcgSodium chloride, 9 mgHydrochloric acid to adjust pH to 4Water for injection, q.s. to 1 mLThe 10 mL vial contains chlorobutanol as a preservative (5 mg/mL).</Description>
</NDC>
<NDC>
<NDCCode>17333-015-01</NDCCode>
<PackageDescription>50 kg in 1 DRUM (17333-015-01)</PackageDescription>
<NDC11Code>17333-0015-01</NDC11Code>
<ProductNDC>17333-015</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Glycine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20141220</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Ajinomoto Co., Inc.</LabelerName>
<SubstanceName>GLYCINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>22100-015-01</NDCCode>
<PackageDescription>236 g in 1 BOTTLE (22100-015-01)</PackageDescription>
<NDC11Code>22100-0015-01</NDC11Code>
<ProductNDC>22100-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healing Waters Cucumber Melon Scented Anti-bacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110507</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>NINGBO MEIDUO GENERAL PRODUCTS CO., LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: To decrease bacteria on the skin that could cause diseases. Recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>