{
"NDC": [
{
"NDCCode": "43602-374-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (43602-374-01) ",
"NDC11Code": "43602-0374-01",
"ProductNDC": "43602-374",
"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": "20210422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213709",
"LabelerName": "Ascent Pharmaceuticals, Inc",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "15; 15; 15; 15",
"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]",
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"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210422",
"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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive."
},
{
"NDCCode": "43602-374-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43602-374-05) ",
"NDC11Code": "43602-0374-05",
"ProductNDC": "43602-374",
"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": "20210422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213709",
"LabelerName": "Ascent Pharmaceuticals, Inc",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "15; 15; 15; 15",
"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": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210422",
"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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive."
},
{
"NDCCode": "43602-176-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (43602-176-01) / 100 CAPSULE in 1 BOTTLE",
"NDC11Code": "43602-0176-01",
"ProductNDC": "43602-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bexarotene",
"NonProprietaryName": "Bexarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208628",
"LabelerName": "Ascent pharmaceutical Inc",
"SubstanceName": "BEXAROTENE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240906",
"SamplePackage": "N",
"IndicationAndUsage": "Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.",
"Description": "Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, polyethylene glycol 400, polysorbate 20 and povidone. The capsule shell contains gelatin, glycerin, sorbitol sorbitan solution and opatint white. The opacode WB black ink contains ferrosoferric oxide, hypromellose, and propylene glycol. The composition of opatint white contain titanium dioxide."
},
{
"NDCCode": "43602-306-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (43602-306-01) ",
"NDC11Code": "43602-0306-01",
"ProductNDC": "43602-306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217442",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]-hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.59. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (986 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Red No. 320 mg: Iron Oxide Yellow30 mg: FD&C Red No. 3 and FD&C Yellow No. 640 mg: FD&C Red No. 3 and FD&C Blue No. 150 mg: FD&C Red No. 3 and FD&C Blue No. 160 mg: FD&C Red No. 3 and FD&C Blue No. 170 mg: FD&C Blue No. 1 and D&C Red 28."
},
{
"NDCCode": "43602-370-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (43602-370-01) ",
"NDC11Code": "43602-0370-01",
"ProductNDC": "43602-370",
"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": "20210422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213709",
"LabelerName": "Ascent Pharmaceuticals, Inc",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210422",
"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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive."
},
{
"NDCCode": "43602-371-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (43602-371-01) ",
"NDC11Code": "43602-0371-01",
"ProductNDC": "43602-371",
"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": "20210422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213709",
"LabelerName": "Ascent Pharmaceuticals, Inc",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210422",
"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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive."
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"NDC11Code": "14141-0374-01",
"ProductNDC": "14141-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Concentre Global Anti Aging Serum Foundation Spf 15 Champagne 170n",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BEL STAR S.A.",
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"StrengthUnit": "mg/mL; mg/mL",
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"LastUpdate": "2025-08-22",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
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"PackageDescription": "30 TABLET in 1 BOTTLE (16714-374-01)",
"NDC11Code": "16714-0374-01",
"ProductNDC": "16714-374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090607",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43063-374-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-374-01)",
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"ProductNDC": "43063-374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49967-374-01",
"PackageDescription": "200 mL in 1 TUBE (49967-374-01) ",
"NDC11Code": "49967-0374-01",
"ProductNDC": "49967-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face And Body Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 70",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20161101",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "50563-375-01",
"PackageDescription": "1 KIT in 1 KIT (50563-375-01) * 20 SOLUTION in 1 PACKET (50563-373-01) * 20 SOLUTION in 1 PACKET (50563-374-01) * 20 SOLUTION in 1 PACKET (50563-372-01) ",
"NDC11Code": "50563-0375-01",
"ProductNDC": "50563-375",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Body Prescriptions Antibacterial Hand Wipes Juicy Peach Peach Mint Strawberry Peach",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20201027",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ENCHANTE ACCESSORIES INC.",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201027",
"SamplePackage": "N"
},
{
"NDCCode": "50580-374-01",
"PackageDescription": "1 KIT in 1 PACKAGE (50580-374-01) * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50580-0374-01",
"ProductNDC": "50580-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Tylenol Cold Plus Flu Multi-action",
"ProprietaryNameSuffix": "Day/night",
"NonProprietaryName": "Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate",
"DosageFormName": "KIT",
"StartMarketingDate": "20210621",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kenvue Brands LLC",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210621",
"SamplePackage": "N"
},
{
"NDCCode": "51021-374-01",
"PackageDescription": "1 KIT in 1 CARTON (51021-374-01) * 150 mL in 1 BOTTLE (51021-250-05) * 234 g in 1 BOTTLE, PLASTIC (64058-247-68)",
"NDC11Code": "51021-0374-01",
"ProductNDC": "51021-374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofex Dc",
"NonProprietaryName": "Diclofenac Sodium And Capsaicin",
"DosageFormName": "KIT",
"StartMarketingDate": "20160430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204132",
"LabelerName": "Sircle Laboratories, LLC",
"Status": "Deprecated",
"LastUpdate": "2018-05-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51060-374-01",
"PackageDescription": "1 TUBE in 1 CARTON (51060-374-01) / 30 mL in 1 TUBE",
"NDC11Code": "51060-0374-01",
"ProductNDC": "51060-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sugar Rush Skin Treat Poreless Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen",
"ProprietaryNameSuffix": "Fair-light",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20231230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Tarte, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "45.5; 35",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231230",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "51079-374-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-374-20) / 1 CAPSULE in 1 BLISTER PACK (51079-374-01) ",
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"ProductNDC": "51079-374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220526",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084768",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220526",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
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},
{
"NDCCode": "51346-374-01",
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"NDC11Code": "51346-0374-01",
"ProductNDC": "51346-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cell Boosting Bb",
"ProprietaryNameSuffix": "Spf30 01 Light Beige",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
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"StrengthUnit": "g/32mL; g/32mL; g/32mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "53208-374-02",
"PackageDescription": "1 CONTAINER in 1 BOX (53208-374-02) > 20 mL in 1 CONTAINER (53208-374-01)",
"NDC11Code": "53208-0374-02",
"ProductNDC": "53208-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gongjinhyang Seol Whitening Intensive",
"NonProprietaryName": "Diacetyl Benzoyl Lathyrol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100326",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part358",
"LabelerName": "LG Household and Healthcare, Inc.",
"SubstanceName": "DIACETYL BENZOYL LATHYROL",
"StrengthNumber": ".1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54860-374-01",
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"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shenzhen Lantern Science Co.,Ltd.",
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"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210407",
"SamplePackage": "Y",
"IndicationAndUsage": "Place enough product on hands to cover all surfaces.Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing."
},
{
"NDCCode": "55648-374-01",
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"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20100806",
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"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach . prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages ."
},
{
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"ProprietaryName": "El Valle Decolorized Iodine",
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"StartMarketingDate": "20230531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Pharmadel LLC",
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"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20230531",
"SamplePackage": "N"
},
{
"NDCCode": "56136-374-01",
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"NDC11Code": "56136-0374-01",
"ProductNDC": "56136-374",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daily Essentials Antibacterial Hand Sanitizer Lavender Scented",
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"ApplicationNumber": "part333E",
"LabelerName": "Ganzhou Olivee Cosmetic Co., Ltd.",
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"StartMarketingDatePackage": "20200708",
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"IndicationAndUsage": "Decreases bacteria on skin."
},
{
"NDCCode": "59368-374-01",
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"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Praxis, LLC",
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"LastUpdate": "2026-01-21",
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"StartMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "60429-374-01",
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"ProprietaryName": "Quetiapine Fumarate",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090960",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "60687-374-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-374-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-374-11) ",
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"ProductNDC": "60687-374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"EndMarketingDate": "20211130",
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"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
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"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190214",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "61219-996-21",
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"ProductNDC": "61219-996",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cushings Syndrome Diagnostic",
"NonProprietaryName": "Decadron-dexamethasone Tablet",
"DosageFormName": "KIT",
"StartMarketingDate": "20161102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088481",
"LabelerName": "Integrated Pharma Solutions Llc",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
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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>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210422</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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>43602-374-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43602-374-05) </PackageDescription>
<NDC11Code>43602-0374-05</NDC11Code>
<ProductNDC>43602-374</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>20210422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213709</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>15; 15; 15; 15</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>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210422</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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>43602-176-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (43602-176-01) / 100 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>43602-0176-01</NDC11Code>
<ProductNDC>43602-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bexarotene</ProprietaryName>
<NonProprietaryName>Bexarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208628</ApplicationNumber>
<LabelerName>Ascent pharmaceutical Inc</LabelerName>
<SubstanceName>BEXAROTENE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.</IndicationAndUsage>
<Description>Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, polyethylene glycol 400, polysorbate 20 and povidone. The capsule shell contains gelatin, glycerin, sorbitol sorbitan solution and opatint white. The opacode WB black ink contains ferrosoferric oxide, hypromellose, and propylene glycol. The composition of opatint white contain titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43602-306-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (43602-306-01) </PackageDescription>
<NDC11Code>43602-0306-01</NDC11Code>
<ProductNDC>43602-306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217442</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]-hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.59. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (986 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&C Red No. 320 mg: Iron Oxide Yellow30 mg: FD&C Red No. 3 and FD&C Yellow No. 640 mg: FD&C Red No. 3 and FD&C Blue No. 150 mg: FD&C Red No. 3 and FD&C Blue No. 160 mg: FD&C Red No. 3 and FD&C Blue No. 170 mg: FD&C Blue No. 1 and D&C Red 28.</Description>
</NDC>
<NDC>
<NDCCode>43602-370-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43602-370-01) </PackageDescription>
<NDC11Code>43602-0370-01</NDC11Code>
<ProductNDC>43602-370</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>20210422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213709</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5; 5; 5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210422</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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>43602-371-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43602-371-01) </PackageDescription>
<NDC11Code>43602-0371-01</NDC11Code>
<ProductNDC>43602-371</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>20210422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213709</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210422</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. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long-Term Use. The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
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<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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
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<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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
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<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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
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<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. * 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied. † 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied. ‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied. § 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied. ¶ 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied. # 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4 .6 mg Amphetamine Aspartate (Anhydrous) as supplied. Þ 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients:. Microcrystalline cellulose, saccharin sodium, maltodextrin, corn starch, colloidal silicon dioxide, sucrose, magnesium stearate. Colors:. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 5 mg is a white to off-white tablet, which contains no color additives. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg and 10 mg contain FD&C Blue #2 as a color additive. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum lake as a color additive.</Description>
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<ApplicationNumber>ANDA090607</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43063-374-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-374-01)</PackageDescription>
<NDC11Code>43063-0374-01</NDC11Code>
<ProductNDC>43063-374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49967-374-01</NDCCode>
<PackageDescription>200 mL in 1 TUBE (49967-374-01) </PackageDescription>
<NDC11Code>49967-0374-01</NDC11Code>
<ProductNDC>49967-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face And Body Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 70</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50563-375-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50563-375-01) * 20 SOLUTION in 1 PACKET (50563-373-01) * 20 SOLUTION in 1 PACKET (50563-374-01) * 20 SOLUTION in 1 PACKET (50563-372-01) </PackageDescription>
<NDC11Code>50563-0375-01</NDC11Code>
<ProductNDC>50563-375</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Body Prescriptions Antibacterial Hand Wipes Juicy Peach Peach Mint Strawberry Peach</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201027</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50580-374-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (50580-374-01) * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50580-0374-01</NDC11Code>
<ProductNDC>50580-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Tylenol Cold Plus Flu Multi-action</ProprietaryName>
<ProprietaryNameSuffix>Day/night</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210621</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51021-374-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51021-374-01) * 150 mL in 1 BOTTLE (51021-250-05) * 234 g in 1 BOTTLE, PLASTIC (64058-247-68)</PackageDescription>
<NDC11Code>51021-0374-01</NDC11Code>
<ProductNDC>51021-374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofex Dc</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Capsaicin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204132</ApplicationNumber>
<LabelerName>Sircle Laboratories, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-05-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51060-374-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51060-374-01) / 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>51060-0374-01</NDC11Code>
<ProductNDC>51060-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sugar Rush Skin Treat Poreless Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Fair-light</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231230</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Tarte, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>45.5; 35</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51079-374-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-374-20) / 1 CAPSULE in 1 BLISTER PACK (51079-374-01) </PackageDescription>
<NDC11Code>51079-0374-20</NDC11Code>
<ProductNDC>51079-374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220526</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084768</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220526</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3 H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is:. C 16H 14ClN 3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, propylene glycol, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>51346-374-01</NDCCode>
<PackageDescription>32 mL in 1 CARTON (51346-374-01)</PackageDescription>
<NDC11Code>51346-0374-01</NDC11Code>
<ProductNDC>51346-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cell Boosting Bb</ProprietaryName>
<ProprietaryNameSuffix>Spf30 01 Light Beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.79; .96; .61</StrengthNumber>
<StrengthUnit>g/32mL; g/32mL; g/32mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53208-374-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (53208-374-02) > 20 mL in 1 CONTAINER (53208-374-01)</PackageDescription>
<NDC11Code>53208-0374-02</NDC11Code>
<ProductNDC>53208-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gongjinhyang Seol Whitening Intensive</ProprietaryName>
<NonProprietaryName>Diacetyl Benzoyl Lathyrol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part358</ApplicationNumber>
<LabelerName>LG Household and Healthcare, Inc.</LabelerName>
<SubstanceName>DIACETYL BENZOYL LATHYROL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54860-374-01</NDCCode>
<PackageDescription>50 CLOTH in 1 PACKAGE (54860-374-01) </PackageDescription>
<NDC11Code>54860-0374-01</NDC11Code>
<ProductNDC>54860-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beautifier Alcohol Wipes 50wipes</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shenzhen Lantern Science Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>1/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210407</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Place enough product on hands to cover all surfaces.Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55648-374-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55648-374-01) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>55648-0374-01</NDC11Code>
<ProductNDC>55648-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090837</ApplicationNumber>
<LabelerName>WOCKHARDT LIMITED</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach . prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55758-374-01</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, PLASTIC (55758-374-01) </PackageDescription>
<NDC11Code>55758-0374-01</NDC11Code>
<ProductNDC>55758-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>El Valle Decolorized Iodine</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>TINCTURE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Pharmadel LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.48</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>56136-374-01</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (56136-374-01) </PackageDescription>
<NDC11Code>56136-0374-01</NDC11Code>
<ProductNDC>56136-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daily Essentials Antibacterial Hand Sanitizer Lavender Scented</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59368-374-01</NDCCode>
<PackageDescription>14 POUCH in 1 CARTON (59368-374-01) / 1 h in 1 POUCH</PackageDescription>
<NDC11Code>59368-0374-01</NDC11Code>
<ProductNDC>59368-374</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Transdermal System</ProprietaryName>
<NonProprietaryName>Nicotine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20240930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074612</ApplicationNumber>
<LabelerName>Praxis, LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-374-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (60429-374-01)</PackageDescription>
<NDC11Code>60429-0374-01</NDC11Code>
<ProductNDC>60429-374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090960</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>60687-374-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-374-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-374-11) </PackageDescription>
<NDC11Code>60687-0374-01</NDC11Code>
<ProductNDC>60687-374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190214</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091083</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190214</StartMarketingDatePackage>
<EndMarketingDatePackage>20211130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61219-996-21</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (61219-996-21) * 2 TABLET in 1 BOTTLE, PLASTIC (61219-084-02) * 3 mL in 1 PACKET (61219-374-01)</PackageDescription>
<NDC11Code>61219-0996-21</NDC11Code>
<ProductNDC>61219-996</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cushings Syndrome Diagnostic</ProprietaryName>
<NonProprietaryName>Decadron-dexamethasone Tablet</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088481</ApplicationNumber>
<LabelerName>Integrated Pharma Solutions Llc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
</NDCList>