{
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"PackageDescription": "30 BLISTER PACK in 1 CARTON (62542-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Extended-release",
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Extended-release",
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Extended-release",
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
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"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
},
{
"NDCCode": "62542-030-31",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-030-31) ",
"NDC11Code": "62542-0030-31",
"ProductNDC": "62542-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Extended-release",
"NonProprietaryName": "Amphetamine Extended-release",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA204326",
"LabelerName": "Neos Therapeutics, LP",
"SubstanceName": "AMPHETAMINE",
"StrengthNumber": "18.8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350."
},
{
"NDCCode": "62542-100-31",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-100-31) ",
"NDC11Code": "62542-0100-31",
"ProductNDC": "62542-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Extended-release",
"NonProprietaryName": "Methylphenidate Extended-release",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205489",
"LabelerName": "Neos Therapeutics, LP",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "8.6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see ClinicalStudies (14)] . Limitations of Use. The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate extended-release orally disintegrating tablets contains methylphenidate, a central nervous system (CNS) stimulant. Methylphenidate extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet intended for once daily administration. Methylphenidate extended-release orally disintegrating tablets contains approximately 25% immediate-release and 75% extended-release methylphenidate. Methylphenidate is ionically-bound to the sulfonate of polystyrene sulfonate particles. Methylphenidate extended-release orally disintegrating tablets contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products. The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate Structure. Methylphenidate extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol 3350."
},
{
"NDCCode": "62542-250-31",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-250-31) ",
"NDC11Code": "62542-0250-31",
"ProductNDC": "62542-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Extended-release",
"NonProprietaryName": "Methylphenidate Extended-release",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205489",
"LabelerName": "Neos Therapeutics, LP",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "17.3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see ClinicalStudies (14)] . Limitations of Use. The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate extended-release orally disintegrating tablets contains methylphenidate, a central nervous system (CNS) stimulant. Methylphenidate extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet intended for once daily administration. Methylphenidate extended-release orally disintegrating tablets contains approximately 25% immediate-release and 75% extended-release methylphenidate. Methylphenidate is ionically-bound to the sulfonate of polystyrene sulfonate particles. Methylphenidate extended-release orally disintegrating tablets contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products. The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate Structure. Methylphenidate extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol 3350."
},
{
"NDCCode": "62542-350-31",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-350-31) ",
"NDC11Code": "62542-0350-31",
"ProductNDC": "62542-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Extended-release",
"NonProprietaryName": "Methylphenidate Extended-release",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205489",
"LabelerName": "Neos Therapeutics, LP",
"SubstanceName": "METHYLPHENIDATE",
"StrengthNumber": "25.9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see ClinicalStudies (14)] . Limitations of Use. The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate extended-release orally disintegrating tablets contains methylphenidate, a central nervous system (CNS) stimulant. Methylphenidate extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet intended for once daily administration. Methylphenidate extended-release orally disintegrating tablets contains approximately 25% immediate-release and 75% extended-release methylphenidate. Methylphenidate is ionically-bound to the sulfonate of polystyrene sulfonate particles. Methylphenidate extended-release orally disintegrating tablets contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products. The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate Structure. Methylphenidate extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol 3350."
},
{
"NDCCode": "10348-010-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (10348-010-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "10348-0010-01",
"ProductNDC": "10348-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Halo Hd Foundation Broad Spectrum Spf 15 Oil Free",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".05635; .03335",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "10631-010-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-010-30) ",
"NDC11Code": "10631-0010-30",
"ProductNDC": "10631-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kapspargo",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210428",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "KAPSPARGO Sprinkle is a beta1-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2) Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalizations in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "11054-010-30",
"PackageDescription": "31 L in 1 CYLINDER (11054-010-30) ",
"NDC11Code": "11054-0010-30",
"ProductNDC": "11054-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen, Refrigerated",
"NonProprietaryName": "Oxygen, Refrigerated",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971014",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205840",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19971014",
"SamplePackage": "N"
},
{
"NDCCode": "11054-010-41",
"PackageDescription": "30 L in 1 CYLINDER (11054-010-41) ",
"NDC11Code": "11054-0010-41",
"ProductNDC": "11054-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen, Refrigerated",
"NonProprietaryName": "Oxygen, Refrigerated",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971014",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205840",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19971014",
"SamplePackage": "N"
},
{
"NDCCode": "11227-010-30",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (11227-010-30) > 5 CAPSULE in 1 BLISTER PACK (11227-010-31)",
"NDC11Code": "11227-0010-30",
"ProductNDC": "11227-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Entereg",
"NonProprietaryName": "Alvimopan",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080520",
"EndMarketingDate": "20141130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021775",
"LabelerName": "Adolor Corporation",
"SubstanceName": "ALVIMOPAN",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-12-05"
},
{
"NDCCode": "11410-010-29",
"PackageDescription": "1 TUBE in 1 BOX (11410-010-29) > 30 mL in 1 TUBE",
"NDC11Code": "11410-0010-29",
"ProductNDC": "11410-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Plus Complexion Perfecting Hydrator",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"EndMarketingDate": "20190630",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "THE PROACTIV COMPANY LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130301",
"EndMarketingDatePackage": "20190630",
"SamplePackage": "N"
},
{
"NDCCode": "13668-010-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (13668-010-30) ",
"NDC11Code": "13668-0010-30",
"ProductNDC": "13668-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071018",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "14783-010-06",
"PackageDescription": "1 BOTTLE in 1 BOX (14783-010-06) > 30 mL in 1 BOTTLE (14783-010-05)",
"NDC11Code": "14783-0010-06",
"ProductNDC": "14783-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait",
"ProprietaryNameSuffix": "Signs Of Age Appearance Minimizer Foundation Spf 20",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".07; .024",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "15127-010-30",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (15127-010-30) > 30 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "15127-0010-30",
"ProductNDC": "15127-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Womens Gentle Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000901",
"EndMarketingDate": "20181214",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "L&R Distributors, Inc.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "16590-010-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-010-30)",
"NDC11Code": "16590-0010-30",
"ProductNDC": "16590-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19930401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019908",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
},
{
"NDCCode": "19339-010-02",
"PackageDescription": "20 POUCH in 1 CARTON (19339-010-02) > 30 mL in 1 POUCH (19339-010-01) ",
"NDC11Code": "19339-0010-02",
"ProductNDC": "19339-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esco Perfect Hand Cleaner",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Arca Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses:Disinfection of hands and skin."
},
{
"NDCCode": "21695-010-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-010-30)",
"NDC11Code": "21695-0010-30",
"ProductNDC": "21695-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19981030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074980",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules, USP and acyclovir tablets, USP are formulations for oral administration. Each capsule of acyclovir contains 200 mg of acyclovir, USP and the inactive ingredients lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell consists of black iron oxide, edible printing ink, gelatin, and titanium dioxide. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and the inactive ingredients colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. Acyclovir, USP is a white crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1, 9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula."
},
{
"NDCCode": "24488-010-10",
"PackageDescription": "30 mL in 1 CANISTER (24488-010-10)",
"NDC11Code": "24488-0010-10",
"ProductNDC": "24488-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roccos Old School",
"ProprietaryNameSuffix": "Healing Balm",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110217",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Roccos Old School",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".9",
"StrengthUnit": "mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Avoid contact with the eyes. In case of contact with eyes, flush thoroughly with water."
},
{
"NDCCode": "25225-010-02",
"PackageDescription": "30 g in 1 BOTTLE, PLASTIC (25225-010-02)",
"NDC11Code": "25225-0010-02",
"ProductNDC": "25225-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peppermint Hand Sanitizer",
"ProprietaryNameSuffix": "None",
"NonProprietaryName": "Peppermint Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091105",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Unique Holding Group Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Put a thumb size amount in your palm and rub your hand briskly until dry."
},
{
"NDCCode": "27281-010-96",
"PackageDescription": "30 mg in 1 BOTTLE, SPRAY (27281-010-96)",
"NDC11Code": "27281-0010-96",
"ProductNDC": "27281-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Tonicity",
"NonProprietaryName": "American Ginseng, Arnica Montana, Turnera Diffusa Leafy Twig, Herring Sperm Dna, Galium Aparine, Hamamelis Virginiana Root Bark/stem Bark, Pork Liver, Cervus Elaphus Horn Oil, Ovis Aries Testicle, Phosphoric Acid, Sus Scrofa Pituitary Gland, Thuja Occidentalis Leafy Twig, Thyroid, Unspecified, Tribulus Terrestris, Ginger",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20140808",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; CERVUS ELAPHUS HORN OIL; OVIS ARIES TESTICLE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; GINGER",
"StrengthNumber": "1.5; 1.5; 1; 3; 1.5; 1.5; 3; 4; 3; 200; 4; 1.5; 6; 1; 1.5",
"StrengthUnit": "[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms of low male sexual energy, including: decrease in sexual desire; feelings of fatigue; decrease in performance and enjoyment."
}
]
}
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<DEASchedule>CII</DEASchedule>
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<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<ApplicationNumber>NDA204326</ApplicationNumber>
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<DEASchedule>CII</DEASchedule>
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<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<PackageDescription>30 BLISTER PACK in 1 CARTON (62542-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62542-0005-30</NDC11Code>
<ProductNDC>62542-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Extended-release</ProprietaryName>
<NonProprietaryName>Amphetamine Extended-release</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA204326</ApplicationNumber>
<LabelerName>Neos Therapeutics, LP</LabelerName>
<SubstanceName>AMPHETAMINE</SubstanceName>
<StrengthNumber>3.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
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<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<NDCCode>62542-005-31</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-005-31) </PackageDescription>
<NDC11Code>62542-0005-31</NDC11Code>
<ProductNDC>62542-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Extended-release</ProprietaryName>
<NonProprietaryName>Amphetamine Extended-release</NonProprietaryName>
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<ApplicationNumber>NDA204326</ApplicationNumber>
<LabelerName>Neos Therapeutics, LP</LabelerName>
<SubstanceName>AMPHETAMINE</SubstanceName>
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<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>62542-015-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (62542-015-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62542-0015-30</NDC11Code>
<ProductNDC>62542-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Extended-release</ProprietaryName>
<NonProprietaryName>Amphetamine Extended-release</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250901</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA204326</ApplicationNumber>
<LabelerName>Neos Therapeutics, LP</LabelerName>
<SubstanceName>AMPHETAMINE</SubstanceName>
<StrengthNumber>9.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>62542-015-31</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62542-015-31) </PackageDescription>
<NDC11Code>62542-0015-31</NDC11Code>
<ProductNDC>62542-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Extended-release</ProprietaryName>
<NonProprietaryName>Amphetamine Extended-release</NonProprietaryName>
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<ApplicationNumber>NDA204326</ApplicationNumber>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
</NDC>
<NDC>
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<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use. The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula. Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see ClinicalStudies (14)] . Limitations of Use. The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate extended-release orally disintegrating tablets contains methylphenidate, a central nervous system (CNS) stimulant. Methylphenidate extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet intended for once daily administration. Methylphenidate extended-release orally disintegrating tablets contains approximately 25% immediate-release and 75% extended-release methylphenidate. Methylphenidate is ionically-bound to the sulfonate of polystyrene sulfonate particles. Methylphenidate extended-release orally disintegrating tablets contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products. The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate Structure. Methylphenidate extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see ClinicalStudies (14)] . Limitations of Use. The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate extended-release orally disintegrating tablets contains methylphenidate, a central nervous system (CNS) stimulant. Methylphenidate extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet intended for once daily administration. Methylphenidate extended-release orally disintegrating tablets contains approximately 25% immediate-release and 75% extended-release methylphenidate. Methylphenidate is ionically-bound to the sulfonate of polystyrene sulfonate particles. Methylphenidate extended-release orally disintegrating tablets contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products. The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate Structure. Methylphenidate extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol 3350.</Description>
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<IndicationAndUsage>Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see ClinicalStudies (14)] . Limitations of Use. The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate extended-release orally disintegrating tablets contains methylphenidate, a central nervous system (CNS) stimulant. Methylphenidate extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet intended for once daily administration. Methylphenidate extended-release orally disintegrating tablets contains approximately 25% immediate-release and 75% extended-release methylphenidate. Methylphenidate is ionically-bound to the sulfonate of polystyrene sulfonate particles. Methylphenidate extended-release orally disintegrating tablets contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products. The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate Structure. Methylphenidate extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>10348-010-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (10348-010-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10348-0010-01</NDC11Code>
<ProductNDC>10348-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Halo Hd Foundation Broad Spectrum Spf 15 Oil Free</ProprietaryName>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.05635; .03335</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10631-010-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-010-30) </PackageDescription>
<NDC11Code>10631-0010-30</NDC11Code>
<ProductNDC>10631-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kapspargo</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210428</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KAPSPARGO Sprinkle is a beta1-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2) Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>11054-010-30</NDCCode>
<PackageDescription>31 L in 1 CYLINDER (11054-010-30) </PackageDescription>
<NDC11Code>11054-0010-30</NDC11Code>
<ProductNDC>11054-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen, Refrigerated</ProprietaryName>
<NonProprietaryName>Oxygen, Refrigerated</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971014</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205840</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11054-010-41</NDCCode>
<PackageDescription>30 L in 1 CYLINDER (11054-010-41) </PackageDescription>
<NDC11Code>11054-0010-41</NDC11Code>
<ProductNDC>11054-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen, Refrigerated</ProprietaryName>
<NonProprietaryName>Oxygen, Refrigerated</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971014</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205840</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11227-010-30</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (11227-010-30) > 5 CAPSULE in 1 BLISTER PACK (11227-010-31)</PackageDescription>
<NDC11Code>11227-0010-30</NDC11Code>
<ProductNDC>11227-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Entereg</ProprietaryName>
<NonProprietaryName>Alvimopan</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080520</StartMarketingDate>
<EndMarketingDate>20141130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021775</ApplicationNumber>
<LabelerName>Adolor Corporation</LabelerName>
<SubstanceName>ALVIMOPAN</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-12-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>11410-010-29</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (11410-010-29) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>11410-0010-29</NDC11Code>
<ProductNDC>11410-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Plus Complexion Perfecting Hydrator</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>THE PROACTIV COMPANY LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-010-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (13668-010-30) </PackageDescription>
<NDC11Code>13668-0010-30</NDC11Code>
<ProductNDC>13668-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>14783-010-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (14783-010-06) > 30 mL in 1 BOTTLE (14783-010-05)</PackageDescription>
<NDC11Code>14783-0010-06</NDC11Code>
<ProductNDC>14783-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait</ProprietaryName>
<ProprietaryNameSuffix>Signs Of Age Appearance Minimizer Foundation Spf 20</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.07; .024</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15127-010-30</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (15127-010-30) > 30 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15127-0010-30</NDC11Code>
<ProductNDC>15127-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Womens Gentle Laxative</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000901</StartMarketingDate>
<EndMarketingDate>20181214</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>L&R Distributors, Inc.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>16590-010-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16590-010-30)</PackageDescription>
<NDC11Code>16590-0010-30</NDC11Code>
<ProductNDC>16590-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambien</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019908</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>19339-010-02</NDCCode>
<PackageDescription>20 POUCH in 1 CARTON (19339-010-02) > 30 mL in 1 POUCH (19339-010-01) </PackageDescription>
<NDC11Code>19339-0010-02</NDC11Code>
<ProductNDC>19339-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esco Perfect Hand Cleaner</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Arca Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses:Disinfection of hands and skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-010-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-010-30)</PackageDescription>
<NDC11Code>21695-0010-30</NDC11Code>
<ProductNDC>21695-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074980</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules, USP and acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules, USP and acyclovir tablets, USP are formulations for oral administration. Each capsule of acyclovir contains 200 mg of acyclovir, USP and the inactive ingredients lactose monohydrate, magnesium stearate, and pregelatinized starch. The capsule shell consists of black iron oxide, edible printing ink, gelatin, and titanium dioxide. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and the inactive ingredients colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. Acyclovir, USP is a white crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1, 9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>24488-010-10</NDCCode>
<PackageDescription>30 mL in 1 CANISTER (24488-010-10)</PackageDescription>
<NDC11Code>24488-0010-10</NDC11Code>
<ProductNDC>24488-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Roccos Old School</ProprietaryName>
<ProprietaryNameSuffix>Healing Balm</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Roccos Old School</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Avoid contact with the eyes. In case of contact with eyes, flush thoroughly with water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25225-010-02</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PLASTIC (25225-010-02)</PackageDescription>
<NDC11Code>25225-0010-02</NDC11Code>
<ProductNDC>25225-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peppermint Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>None</ProprietaryNameSuffix>
<NonProprietaryName>Peppermint Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Unique Holding Group Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Put a thumb size amount in your palm and rub your hand briskly until dry.</Description>
</NDC>
<NDC>
<NDCCode>27281-010-96</NDCCode>
<PackageDescription>30 mg in 1 BOTTLE, SPRAY (27281-010-96)</PackageDescription>
<NDC11Code>27281-0010-96</NDC11Code>
<ProductNDC>27281-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Tonicity</ProprietaryName>
<NonProprietaryName>American Ginseng, Arnica Montana, Turnera Diffusa Leafy Twig, Herring Sperm Dna, Galium Aparine, Hamamelis Virginiana Root Bark/stem Bark, Pork Liver, Cervus Elaphus Horn Oil, Ovis Aries Testicle, Phosphoric Acid, Sus Scrofa Pituitary Gland, Thuja Occidentalis Leafy Twig, Thyroid, Unspecified, Tribulus Terrestris, Ginger</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140808</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; CERVUS ELAPHUS HORN OIL; OVIS ARIES TESTICLE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; GINGER</SubstanceName>
<StrengthNumber>1.5; 1.5; 1; 3; 1.5; 1.5; 3; 4; 3; 200; 4; 1.5; 6; 1; 1.5</StrengthNumber>
<StrengthUnit>[hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms of low male sexual energy, including: decrease in sexual desire; feelings of fatigue; decrease in performance and enjoyment.</IndicationAndUsage>
</NDC>
</NDCList>