{
"NDC": [
{
"NDCCode": "62372-551-50",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-551-50) ",
"NDC11Code": "62372-0551-50",
"ProductNDC": "62372-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mylanta One Antacid/anti-gas",
"NonProprietaryName": "Calcium Carbonate, Magnesium Hydroxide, Dimethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210504",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Infirst Healthcare Inc.",
"SubstanceName": "CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "1000; 270; 80",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210504",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach due to these symptoms, 5 pressure and bloating commonly referred to as gas, 6 overindulgence in food and drink."
},
{
"NDCCode": "62372-551-51",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE (62372-551-51) ",
"NDC11Code": "62372-0551-51",
"ProductNDC": "62372-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mylanta One Antacid/anti-gas",
"NonProprietaryName": "Calcium Carbonate, Magnesium Hydroxide, Dimethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210504",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Infirst Healthcare Inc.",
"SubstanceName": "CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "1000; 270; 80",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210816",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach due to these symptoms, 5 pressure and bloating commonly referred to as gas, 6 overindulgence in food and drink."
},
{
"NDCCode": "62372-552-50",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-552-50) ",
"NDC11Code": "62372-0552-50",
"ProductNDC": "62372-552",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mylanta One Antacid/anti-gas",
"NonProprietaryName": "Calcium Carbonate, Magnesium Hydroxide, Dimethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210504",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Infirst Healthcare Inc.",
"SubstanceName": "CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "1000; 270; 80",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210504",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach due to these symptoms, 5 pressure and bloating commonly referred to as gas, 6 overindulgence in food and drink."
},
{
"NDCCode": "62372-552-51",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE (62372-552-51) ",
"NDC11Code": "62372-0552-51",
"ProductNDC": "62372-552",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mylanta One Antacid/anti-gas",
"NonProprietaryName": "Calcium Carbonate, Magnesium Hydroxide, Dimethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210504",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Infirst Healthcare Inc.",
"SubstanceName": "CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "1000; 270; 80",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210816",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach due to these symptoms, 5 pressure and bloating commonly referred to as gas, 6 overindulgence in food and drink."
},
{
"NDCCode": "62372-800-50",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-800-50) ",
"NDC11Code": "62372-0800-50",
"ProductNDC": "62372-800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mylanta Gas Minis Mint Flavor",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "Infirst Healthcare Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160321",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves pressure and bloating commonly referred to as gas."
},
{
"NDCCode": "62372-801-50",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-801-50) ",
"NDC11Code": "62372-0801-50",
"ProductNDC": "62372-801",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mylanta Gas Minis Assorted Fruit Flavor",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Infirst Healthcare Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160321",
"SamplePackage": "N"
},
{
"NDCCode": "62372-802-50",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-802-50) ",
"NDC11Code": "62372-0802-50",
"ProductNDC": "62372-802",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mylanta Gas Minis Cherry Flavor",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190805",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Infirst Healthcare Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190805",
"SamplePackage": "N"
},
{
"NDCCode": "30032-551-10",
"PackageDescription": "50 kg in 1 DRUM (30032-551-10) ",
"NDC11Code": "30032-0551-10",
"ProductNDC": "30032-551",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Thatcher Company",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-10-26",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "29-MAR-13"
},
{
"NDCCode": "50268-551-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-551-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-551-11) ",
"NDC11Code": "50268-0551-15",
"ProductNDC": "50268-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078321",
"LabelerName": "AvPAK",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220502",
"SamplePackage": "N"
},
{
"NDCCode": "62157-551-01",
"PackageDescription": "50 g in 1 JAR (62157-551-01)",
"NDC11Code": "62157-0551-01",
"ProductNDC": "62157-551",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cisapride Monohydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180406",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "CISAPRIDE MONOHYDRATE",
"StrengthNumber": "49.5",
"StrengthUnit": "g/50g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "71919-551-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-551-09) ",
"NDC11Code": "71919-0551-09",
"ProductNDC": "71919-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Podophyllum Peltatum",
"NonProprietaryName": "Podophyllum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100630",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PODOPHYLLUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100630",
"SamplePackage": "N"
},
{
"NDCCode": "83021-551-50",
"PackageDescription": "50 mL in 1 BOTTLE (83021-551-50) ",
"NDC11Code": "83021-0551-50",
"ProductNDC": "83021-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubismed",
"NonProprietaryName": "Spf 50 Broad Spectrum Protection Fluid Emulsion",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221015",
"EndMarketingDate": "20270429",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; GLYCERIN; LINOLENIC ACID; TROMETHAMINE; OCTOCRYLENE; BUTYLATED HYDROXYTOLUENE; PROPYLENE GLYCOL; WATER; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); .ALPHA.-TOCOPHEROL; POLY(METHYL METHACRYLATE; 450000 MW); AVOBENZONE; TITANIUM DIOXIDE; PHENOXYETHANOL; POLYETHYLENE GLYCOL 400; LINOLEIC ACID; SILICON DIOXIDE; ANHYDROUS CITRIC ACID; ASCORBYL PALMITATE; ASCORBIC ACID; OCTISALATE; BEMOTRIZINOL; DIMETHICONE; OCTINOXATE; BUTYLENE GLYCOL; C20-22 ALCOHOLS; CHLORPHENESIN",
"StrengthNumber": ".025; .005; .00275; .22; 1.8; .0018; 2.5; 27.55; .3; .075; .006; 2.1; 1.8; .425; .35; .14225; .49725; .575; .00025; .00125; .00025; 1.8; 1.45; 1.25; 3.5982; 2.5; .3375; .1",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Anti-coagulant [EPC], Ascorbic Acid [CS], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221015",
"EndMarketingDatePackage": "20270429",
"SamplePackage": "N"
},
{
"NDCCode": "84756-551-04",
"PackageDescription": "50 g in 1 BOX (84756-551-04) ",
"NDC11Code": "84756-0551-04",
"ProductNDC": "84756-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Retinol Moisturizing Crean",
"NonProprietaryName": "Trstay Retinol Moisturizing Crean",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241202",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "62372-710-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (62372-710-04) > 120 mL in 1 BOTTLE",
"NDC11Code": "62372-0710-04",
"ProductNDC": "62372-710",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr. Cocoa Mucus Relief",
"NonProprietaryName": "Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150722",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Infirst Healthcare, Inc.",
"SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20150722",
"EndMarketingDatePackage": "20171231",
"SamplePackage": "N"
},
{
"NDCCode": "43598-551-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-551-30) ",
"NDC11Code": "43598-0551-30",
"ProductNDC": "43598-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20160617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206382",
"LabelerName": "Dr. Reddy�s Laboratories Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160617",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older. : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. ( 1.1) .",
"Description": "Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.1. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in anhydrous ethanol, practically insoluble in dilute hydrochloric acid and in water. The structural formula is:. Lamotrigine Orally Disintegrating Tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: amino methacrylate copolymer, aspartame, colloidal silicon dioxide, crospovidone, kollidon SR, magnesium stearate, mannitol, sucralose and artificial cherry flavor containing dextrose, corn starch, and tricalcium phosphate."
},
{
"NDCCode": "43602-551-05",
"PackageDescription": "500 TABLET, CHEWABLE in 1 BOTTLE (43602-551-05) ",
"NDC11Code": "43602-0551-05",
"ProductNDC": "43602-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217068",
"LabelerName": "Ascent Pharmaceuticals, Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]-hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.59. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (986 mg/mL). Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: Microcrystalline cellulose and guar gum, croscarmellose sodium, mannitol, sucralose, natural grape flavor, colloidal silicon dioxide, and magnesium stearate. Natural grape flavor contains maltodextrin, modified food starch (tapioca/waxy maize), natural flavor, triglycerides (medium chain), citric acid, tartaric acid and sodium benzoate."
},
{
"NDCCode": "43602-551-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (43602-551-30) ",
"NDC11Code": "43602-0551-30",
"ProductNDC": "43602-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217068",
"LabelerName": "Ascent Pharmaceuticals, Inc",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]-hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.59. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (986 mg/mL). Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: Microcrystalline cellulose and guar gum, croscarmellose sodium, mannitol, sucralose, natural grape flavor, colloidal silicon dioxide, and magnesium stearate. Natural grape flavor contains maltodextrin, modified food starch (tapioca/waxy maize), natural flavor, triglycerides (medium chain), citric acid, tartaric acid and sodium benzoate."
},
{
"NDCCode": "44114-551-14",
"PackageDescription": "14 g in 1 TUBE (44114-551-14) ",
"NDC11Code": "44114-0551-14",
"ProductNDC": "44114-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laspa Ultra Sun Stick",
"NonProprietaryName": "Pf 50 Broad Spectrum Mineral Sunscreen",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Vegewax Candleworx Ltd",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "25; 3.8",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "45865-551-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (45865-551-90) ",
"NDC11Code": "45865-0551-90",
"ProductNDC": "45865-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "medsource pharmaceuticals",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: Epilepsy: initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2) Prophylaxis of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-¬Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "46708-551-30",
"PackageDescription": "1 TUBE in 1 CARTON (46708-551-30) / 30 g in 1 TUBE",
"NDC11Code": "46708-0551-30",
"ProductNDC": "46708-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "46708-551-60",
"PackageDescription": "1 TUBE in 1 CARTON (46708-551-60) / 60 g in 1 TUBE",
"NDC11Code": "46708-0551-60",
"ProductNDC": "46708-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "46708-551-90",
"PackageDescription": "1 TUBE in 1 CARTON (46708-551-90) / 90 g in 1 TUBE",
"NDC11Code": "46708-0551-90",
"ProductNDC": "46708-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "49358-551-01",
"PackageDescription": "1 TUBE in 1 CARTON (49358-551-01) > 35 g in 1 TUBE",
"NDC11Code": "49358-0551-01",
"ProductNDC": "49358-551",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Beauty Balm",
"ProprietaryNameSuffix": "Broad Spectrum Spf 50 Sunscreen Uva-uvb Suncreen Medium/dark",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "MDSolarSciences",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "2.7; 1.3",
"StrengthUnit": "g/35g; g/35g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140401",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "49884-424-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-424-11) ",
"NDC11Code": "49884-0424-11",
"ProductNDC": "49884-424",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aliskiren",
"NonProprietaryName": "Aliskiren",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206665",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ALISKIREN HEMIFUMARATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC], Renin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190325",
"SamplePackage": "N",
"IndicationAndUsage": "Aliskiren tablets are a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Aliskiren tablets contain aliskiren hemifumarate, a direct renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water. Aliskiren is available as film-coated tablets, which contains 165.765 mg or 331.530 mg aliskiren hemifumarate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. In addition, the 150 mg strength contains iron oxide black."
},
{
"NDCCode": "49884-425-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11) ",
"NDC11Code": "49884-0425-11",
"ProductNDC": "49884-425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aliskiren",
"NonProprietaryName": "Aliskiren",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206665",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ALISKIREN HEMIFUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC], Renin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190325",
"SamplePackage": "N",
"IndicationAndUsage": "Aliskiren tablets are a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Aliskiren tablets contain aliskiren hemifumarate, a direct renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water. Aliskiren is available as film-coated tablets, which contains 165.765 mg or 331.530 mg aliskiren hemifumarate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. In addition, the 150 mg strength contains iron oxide black."
},
{
"NDCCode": "50090-2985-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-2985-0) ",
"NDC11Code": "50090-2985-00",
"ProductNDC": "50090-2985",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tekturna",
"NonProprietaryName": "Aliskiren Hemifumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070305",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021985",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ALISKIREN HEMIFUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Renin Inhibitor [EPC], Renin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170425",
"SamplePackage": "N",
"IndicationAndUsage": "Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).",
"Description": "Tekturna contains aliskiren hemifumarate, adirect renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy- 2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C 30H 53N 3O 6 0.5 C 4H 4O 4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water. Tekturna is available as film-coated tablets, which contains 165.75 mg or 331.5 mg aliskiren hemifumerate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: crospovidone; magnesium stearate; microcrystalline cellulose; povidone; silica, colloidal anhydrous; hypromellose; macrogol; talc; iron oxide, black (E 172); iron oxide, red (E 172); titanium dioxide (E 171)."
},
{
"NDCCode": "51407-551-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-551-01) ",
"NDC11Code": "51407-0551-01",
"ProductNDC": "51407-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191211",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212037",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201119",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. ( 14) , 2 Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. ( 14) , 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. ( 14) .",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
},
{
"NDCCode": "62332-551-30",
"PackageDescription": "1 TUBE in 1 CARTON (62332-551-30) / 30 g in 1 TUBE",
"NDC11Code": "62332-0551-30",
"ProductNDC": "62332-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "62332-551-60",
"PackageDescription": "1 TUBE in 1 CARTON (62332-551-60) / 60 g in 1 TUBE",
"NDC11Code": "62332-0551-60",
"ProductNDC": "62332-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DAPSONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
},
{
"NDCCode": "62332-551-90",
"PackageDescription": "1 TUBE in 1 CARTON (62332-551-90) / 90 g in 1 TUBE",
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"NonProprietaryName": "Dapsone",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213414",
"LabelerName": "Alembic Pharmaceuticals Inc.",
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"IndicationAndUsage": "Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.",
"Description": "Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water."
}
]
}
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<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ProprietaryName>Mylanta One Antacid/anti-gas</ProprietaryName>
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<StartMarketingDatePackage>20210816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>62372-800-50</NDCCode>
<PackageDescription>50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-800-50) </PackageDescription>
<NDC11Code>62372-0800-50</NDC11Code>
<ProductNDC>62372-800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mylanta Gas Minis Mint Flavor</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Infirst Healthcare Inc.</LabelerName>
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</NDC>
<NDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<LabelerName>Infirst Healthcare Inc.</LabelerName>
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<NDC>
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<PackageDescription>50 BLISTER PACK in 1 BOX (50268-551-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-551-11) </PackageDescription>
<NDC11Code>50268-0551-15</NDC11Code>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<DosageFormName>POWDER</DosageFormName>
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<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
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<SubstanceName>CISAPRIDE MONOHYDRATE</SubstanceName>
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<StrengthUnit>g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71919-551-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-551-09) </PackageDescription>
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<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
</NDC>
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<Status>Active</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221015</StartMarketingDatePackage>
<EndMarketingDatePackage>20270429</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
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<NonProprietaryName>Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150722</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Infirst Healthcare, Inc.</LabelerName>
<SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150722</StartMarketingDatePackage>
<EndMarketingDatePackage>20171231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43598-551-30</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-551-30) </PackageDescription>
<NDC11Code>43598-0551-30</NDC11Code>
<ProductNDC>43598-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206382</ApplicationNumber>
<LabelerName>Dr. Reddy�s Laboratories Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older. : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. ( 1.1) .</IndicationAndUsage>
<Description>Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.1. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in anhydrous ethanol, practically insoluble in dilute hydrochloric acid and in water. The structural formula is:. Lamotrigine Orally Disintegrating Tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: amino methacrylate copolymer, aspartame, colloidal silicon dioxide, crospovidone, kollidon SR, magnesium stearate, mannitol, sucralose and artificial cherry flavor containing dextrose, corn starch, and tricalcium phosphate.</Description>
</NDC>
<NDC>
<NDCCode>43602-551-05</NDCCode>
<PackageDescription>500 TABLET, CHEWABLE in 1 BOTTLE (43602-551-05) </PackageDescription>
<NDC11Code>43602-0551-05</NDC11Code>
<ProductNDC>43602-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217068</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]-hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.59. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (986 mg/mL). Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: Microcrystalline cellulose and guar gum, croscarmellose sodium, mannitol, sucralose, natural grape flavor, colloidal silicon dioxide, and magnesium stearate. Natural grape flavor contains maltodextrin, modified food starch (tapioca/waxy maize), natural flavor, triglycerides (medium chain), citric acid, tartaric acid and sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>43602-551-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (43602-551-30) </PackageDescription>
<NDC11Code>43602-0551-30</NDC11Code>
<ProductNDC>43602-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217068</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]-hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.59. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (986 mg/mL). Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: Microcrystalline cellulose and guar gum, croscarmellose sodium, mannitol, sucralose, natural grape flavor, colloidal silicon dioxide, and magnesium stearate. Natural grape flavor contains maltodextrin, modified food starch (tapioca/waxy maize), natural flavor, triglycerides (medium chain), citric acid, tartaric acid and sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>44114-551-14</NDCCode>
<PackageDescription>14 g in 1 TUBE (44114-551-14) </PackageDescription>
<NDC11Code>44114-0551-14</NDC11Code>
<ProductNDC>44114-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laspa Ultra Sun Stick</ProprietaryName>
<NonProprietaryName>Pf 50 Broad Spectrum Mineral Sunscreen</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Vegewax Candleworx Ltd</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>25; 3.8</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45865-551-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (45865-551-90) </PackageDescription>
<NDC11Code>45865-0551-90</NDC11Code>
<ProductNDC>45865-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>medsource pharmaceuticals</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: Epilepsy: initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2) Prophylaxis of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-¬Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>46708-551-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (46708-551-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>46708-0551-30</NDC11Code>
<ProductNDC>46708-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>46708-551-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (46708-551-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>46708-0551-60</NDC11Code>
<ProductNDC>46708-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>46708-551-90</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (46708-551-90) / 90 g in 1 TUBE</PackageDescription>
<NDC11Code>46708-0551-90</NDC11Code>
<ProductNDC>46708-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>49358-551-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (49358-551-01) > 35 g in 1 TUBE</PackageDescription>
<NDC11Code>49358-0551-01</NDC11Code>
<ProductNDC>49358-551</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Beauty Balm</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 50 Sunscreen Uva-uvb Suncreen Medium/dark</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>MDSolarSciences</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.7; 1.3</StrengthNumber>
<StrengthUnit>g/35g; g/35g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49884-424-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (49884-424-11) </PackageDescription>
<NDC11Code>49884-0424-11</NDC11Code>
<ProductNDC>49884-424</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aliskiren</ProprietaryName>
<NonProprietaryName>Aliskiren</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206665</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ALISKIREN HEMIFUMARATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Renin Inhibitor [EPC], Renin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aliskiren tablets are a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Aliskiren tablets contain aliskiren hemifumarate, a direct renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water. Aliskiren is available as film-coated tablets, which contains 165.765 mg or 331.530 mg aliskiren hemifumarate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. In addition, the 150 mg strength contains iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>49884-425-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11) </PackageDescription>
<NDC11Code>49884-0425-11</NDC11Code>
<ProductNDC>49884-425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aliskiren</ProprietaryName>
<NonProprietaryName>Aliskiren</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206665</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ALISKIREN HEMIFUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Renin Inhibitor [EPC], Renin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aliskiren tablets are a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Aliskiren tablets contain aliskiren hemifumarate, a direct renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C30H53N3O6 0.5 C4H4O4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water. Aliskiren is available as film-coated tablets, which contains 165.765 mg or 331.530 mg aliskiren hemifumarate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. In addition, the 150 mg strength contains iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>50090-2985-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-2985-0) </PackageDescription>
<NDC11Code>50090-2985-00</NDC11Code>
<ProductNDC>50090-2985</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tekturna</ProprietaryName>
<NonProprietaryName>Aliskiren Hemifumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070305</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021985</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ALISKIREN HEMIFUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Renin Inhibitor [EPC], Renin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
<Description>Tekturna contains aliskiren hemifumarate, adirect renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy- 2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is. Molecular formula: C 30H 53N 3O 6 0.5 C 4H 4O 4. Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water. Tekturna is available as film-coated tablets, which contains 165.75 mg or 331.5 mg aliskiren hemifumerate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: crospovidone; magnesium stearate; microcrystalline cellulose; povidone; silica, colloidal anhydrous; hypromellose; macrogol; talc; iron oxide, black (E 172); iron oxide, red (E 172); titanium dioxide (E 171).</Description>
</NDC>
<NDC>
<NDCCode>51407-551-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-551-01) </PackageDescription>
<NDC11Code>51407-0551-01</NDC11Code>
<ProductNDC>51407-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191211</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212037</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5; 5; 5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201119</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. ( 14) , 2 Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. ( 14) , 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. ( 14) .</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>62332-551-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-551-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0551-30</NDC11Code>
<ProductNDC>62332-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62332-551-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-551-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0551-60</NDC11Code>
<ProductNDC>62332-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62332-551-90</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-551-90) / 90 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0551-90</NDC11Code>
<ProductNDC>62332-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213414</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Dapsone Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is. Each gram of dapsone gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.</Description>
</NDC>
</NDCList>