{
"NDC": [
{
"NDCCode": "68382-550-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-01) ",
"NDC11Code": "68382-0550-01",
"ProductNDC": "68382-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203553",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending."
},
{
"NDCCode": "68382-550-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-05) ",
"NDC11Code": "68382-0550-05",
"ProductNDC": "68382-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203553",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending."
},
{
"NDCCode": "68382-550-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-06) ",
"NDC11Code": "68382-0550-06",
"ProductNDC": "68382-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203553",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending."
},
{
"NDCCode": "68382-550-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-10) ",
"NDC11Code": "68382-0550-10",
"ProductNDC": "68382-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203553",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending."
},
{
"NDCCode": "68382-550-16",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-16) ",
"NDC11Code": "68382-0550-16",
"ProductNDC": "68382-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203553",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending."
},
{
"NDCCode": "68382-550-30",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-550-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "68382-0550-30",
"ProductNDC": "68382-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203553",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending."
},
{
"NDCCode": "10914-550-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (10914-550-01)",
"NDC11Code": "10914-0550-01",
"ProductNDC": "10914-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040658",
"LabelerName": "Brighton Pharmaceuticals, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "300; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "13537-550-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-550-02) > 4 g in 1 TUBE (13537-550-01)",
"NDC11Code": "13537-0550-02",
"ProductNDC": "13537-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Couleur Luxe Amplifier Xp",
"ProprietaryNameSuffix": "Amplifying Spf 15 - Fucsia Desir",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".047; .009",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-550-01",
"PackageDescription": "60 TABLET in 1 BOTTLE (16714-550-01) ",
"NDC11Code": "16714-0550-01",
"ProductNDC": "16714-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208308",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 1 month of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "21839-550-01",
"PackageDescription": "1 BOTTLE in 1 BOX (21839-550-01) > 44 mL in 1 BOTTLE (21839-550-02) ",
"NDC11Code": "21839-0550-01",
"ProductNDC": "21839-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coola Mineral Sun Silk Creme Sunscreen",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181211",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "GORDON LABORATORIES,INC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181211",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. * helps prevent sunburn. * if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "24338-550-01",
"PackageDescription": "1 KIT in 1 KIT (24338-550-01) ",
"NDC11Code": "24338-0550-01",
"ProductNDC": "24338-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suflave",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution",
"DosageFormName": "KIT",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215344",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.",
"Description": "SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative and is provided in two bottles and two flavor enhancing packets for oral solution. The active ingredients contained in SUFLAVE are provided in Table 3. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride, plus the following excipients: advantame, lemon-lime flavor, and neotame. Each flavor enhancing packet contains anhydrous citric acid, colloidal silicon dioxide, malic acid, and sucralose. Each dose of reconstituted oral solution is one liter of slightly hazy to hazy liquid that contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride and the following excipients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose."
},
{
"NDCCode": "42291-550-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42291-550-01)",
"NDC11Code": "42291-0550-01",
"ProductNDC": "42291-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propylthiouracil",
"NonProprietaryName": "Propylthiouracil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080154",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "PROPYLTHIOURACIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-02-12"
},
{
"NDCCode": "42326-550-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42326-550-01) > 4000 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "42326-0550-01",
"ProductNDC": "42326-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Athleticare Anti-bacterial Hand Ac 550",
"NonProprietaryName": "Triclosan",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160305",
"EndMarketingDate": "20210523",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Petra Hygienic Systems Int Ltd",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160305",
"EndMarketingDatePackage": "20210523",
"SamplePackage": "N"
},
{
"NDCCode": "42953-001-01",
"PackageDescription": "550 mL in 1 BOTTLE (42953-001-01) ",
"NDC11Code": "42953-0001-01",
"ProductNDC": "42953-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Defender Foaming Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121011",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Scientific Molecular Technologies",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20121011",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin that could cause disease. Recommended for repeated use. ."
},
{
"NDCCode": "42953-002-01",
"PackageDescription": "550 mL in 1 BOTTLE, PUMP (42953-002-01) ",
"NDC11Code": "42953-0002-01",
"ProductNDC": "42953-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Defender Antiseptic Foam Hand Sanitizer Alcohol-free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121011",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Scientific Molecular Technologies",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20121011",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. ."
},
{
"NDCCode": "43598-550-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-550-01) ",
"NDC11Code": "43598-0550-01",
"ProductNDC": "43598-550",
"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": "25",
"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": "43979-550-01",
"PackageDescription": "3 mL in 1 POUCH (43979-550-01)",
"NDC11Code": "43979-0550-01",
"ProductNDC": "43979-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Out Back Pain Relief",
"NonProprietaryName": "Tea Tree Oil And Eucalyptus Oil",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Elmore Oil Company Pty Ltd",
"SubstanceName": "TEA TREE OIL; EUCALYPTUS OIL",
"StrengthNumber": "42.5; 38.6",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporary relief of joint and muscle pain, including lower back pain."
},
{
"NDCCode": "47781-550-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (47781-550-01) ",
"NDC11Code": "47781-0550-01",
"ProductNDC": "47781-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161228",
"EndMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204595",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161228",
"EndMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "49358-550-01",
"PackageDescription": "1 TUBE in 1 CARTON (49358-550-01) > 35 g in 1 TUBE",
"NDC11Code": "49358-0550-01",
"ProductNDC": "49358-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Beauty Balm",
"ProprietaryNameSuffix": "Broad Spectrum Spf 50 Sunscreen Uva-uvb Suncreen Light/medium",
"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": "50021-020-01",
"PackageDescription": "550 mL in 1 BOTTLE, PUMP (50021-020-01) ",
"NDC11Code": "50021-0020-01",
"ProductNDC": "50021-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201111",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Empack Spraytech Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201111",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use whensoap and water are not available."
},
{
"NDCCode": "50269-550-01",
"PackageDescription": "20 POUCH in 1 BOX (50269-550-01) / 2 TABLET, FILM COATED in 1 POUCH",
"NDC11Code": "50269-0550-01",
"ProductNDC": "50269-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Cold Flu Severe",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "JC World Bell Wholesale Co., Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110901",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of the following cold/flu symptoms:. minor aches and pains . headache. sore throat. nasal congestion. cough. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily reduces fever."
},
{
"NDCCode": "50458-550-01",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01) ",
"NDC11Code": "50458-0550-01",
"ProductNDC": "50458-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20061219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021999",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061219",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA is an atypical antipsychotic agent indicated for. Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "INVEGA ® contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. INVEGA (paliperidone) Extended-Release Tablets are intended for oral administration and are available in 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. INVEGA utilizes OROS ® osmotic drug-release technology. Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethyl cellulose, propylene glycol, polyethylene glycol, polyethylene oxides, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin."
},
{
"NDCCode": "50742-550-05",
"PackageDescription": "5 POUCH in 1 CARTON (50742-550-05) / 1 PATCH in 1 POUCH (50742-550-01) / 72 h in 1 PATCH",
"NDC11Code": "50742-0550-05",
"ProductNDC": "50742-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077449",
"LabelerName": "INGENUS PHARMACEUTICALS, LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "25",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1)] , reserve opioid analgesics, including fentanyl transdermal system for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2). The composition per unit area of all transdermal system sizes is identical. * Nominal delivery rate is 12.5 mcg/hour ** Nominal delivery rate per hour. The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22H 28N 2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal system is a rectangular transparent unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of polyethylene terephalate film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded."
},
{
"NDCCode": "51021-582-01",
"PackageDescription": "1 KIT in 1 CARTON (51021-582-01) * 150 mL in 1 BOTTLE (51021-250-05) * 30 mL in 1 BOTTLE, DROPPER (51021-550-30) ",
"NDC11Code": "51021-0582-01",
"ProductNDC": "51021-582",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dynabac 5.0",
"NonProprietaryName": "Diclofenac Sodium And Cannabidiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20190531",
"EndMarketingDate": "20210101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204132",
"LabelerName": "Sircle Laboratories, LLC",
"Status": "Deprecated",
"LastUpdate": "2019-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190531",
"EndMarketingDatePackage": "20210101",
"SamplePackage": "N"
},
{
"NDCCode": "51407-550-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-550-01) ",
"NDC11Code": "51407-0550-01",
"ProductNDC": "51407-550",
"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": "3.75; 3.75; 3.75; 3.75",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "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": "52268-550-01",
"PackageDescription": "1 KIT in 1 KIT (52268-550-01) ",
"NDC11Code": "52268-0550-01",
"ProductNDC": "52268-550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suflave",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution",
"DosageFormName": "KIT",
"StartMarketingDate": "20230615",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215344",
"LabelerName": "Braintree Laboratories, Inc.",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230615",
"EndMarketingDatePackage": "20280229",
"SamplePackage": "N"
},
{
"NDCCode": "52854-550-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (52854-550-01)",
"NDC11Code": "52854-0550-01",
"ProductNDC": "52854-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Reef Babies Spf 50",
"NonProprietaryName": "Octocrylene, Octisalate, Oxybenzone, And Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Tropical Seas, Inc.",
"SubstanceName": "OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE",
"StrengthNumber": "5; 5; 4; 2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "53194-003-01",
"PackageDescription": "550 kg in 1 CONTAINER (53194-003-01)",
"NDC11Code": "53194-0003-01",
"ProductNDC": "53194-003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Medium-chain Triglycerides",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20150918",
"MarketingCategoryName": "BULK INGREDIENT",
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<Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
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<Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
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<NDC11Code>16714-0550-01</NDC11Code>
<ProductNDC>16714-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208308</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 1 month of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>21839-550-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (21839-550-01) > 44 mL in 1 BOTTLE (21839-550-02) </PackageDescription>
<NDC11Code>21839-0550-01</NDC11Code>
<ProductNDC>21839-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coola Mineral Sun Silk Creme Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>GORDON LABORATORIES,INC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. * helps prevent sunburn. * if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24338-550-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (24338-550-01) </PackageDescription>
<NDC11Code>24338-0550-01</NDC11Code>
<ProductNDC>24338-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suflave</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215344</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative and is provided in two bottles and two flavor enhancing packets for oral solution. The active ingredients contained in SUFLAVE are provided in Table 3. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride, plus the following excipients: advantame, lemon-lime flavor, and neotame. Each flavor enhancing packet contains anhydrous citric acid, colloidal silicon dioxide, malic acid, and sucralose. Each dose of reconstituted oral solution is one liter of slightly hazy to hazy liquid that contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride and the following excipients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>42291-550-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42291-550-01)</PackageDescription>
<NDC11Code>42291-0550-01</NDC11Code>
<ProductNDC>42291-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propylthiouracil</ProprietaryName>
<NonProprietaryName>Propylthiouracil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080154</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>PROPYLTHIOURACIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-02-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>42326-550-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42326-550-01) > 4000 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>42326-0550-01</NDC11Code>
<ProductNDC>42326-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Athleticare Anti-bacterial Hand Ac 550</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160305</StartMarketingDate>
<EndMarketingDate>20210523</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Petra Hygienic Systems Int Ltd</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160305</StartMarketingDatePackage>
<EndMarketingDatePackage>20210523</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42953-001-01</NDCCode>
<PackageDescription>550 mL in 1 BOTTLE (42953-001-01) </PackageDescription>
<NDC11Code>42953-0001-01</NDC11Code>
<ProductNDC>42953-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Defender Foaming Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121011</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Scientific Molecular Technologies</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin that could cause disease. Recommended for repeated use. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42953-002-01</NDCCode>
<PackageDescription>550 mL in 1 BOTTLE, PUMP (42953-002-01) </PackageDescription>
<NDC11Code>42953-0002-01</NDC11Code>
<ProductNDC>42953-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Defender Antiseptic Foam Hand Sanitizer Alcohol-free</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121011</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Scientific Molecular Technologies</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-550-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43598-550-01) </PackageDescription>
<NDC11Code>43598-0550-01</NDC11Code>
<ProductNDC>43598-550</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>25</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>43979-550-01</NDCCode>
<PackageDescription>3 mL in 1 POUCH (43979-550-01)</PackageDescription>
<NDC11Code>43979-0550-01</NDC11Code>
<ProductNDC>43979-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Out Back Pain Relief</ProprietaryName>
<NonProprietaryName>Tea Tree Oil And Eucalyptus Oil</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Elmore Oil Company Pty Ltd</LabelerName>
<SubstanceName>TEA TREE OIL; EUCALYPTUS OIL</SubstanceName>
<StrengthNumber>42.5; 38.6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporary relief of joint and muscle pain, including lower back pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47781-550-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (47781-550-01) </PackageDescription>
<NDC11Code>47781-0550-01</NDC11Code>
<ProductNDC>47781-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161228</StartMarketingDate>
<EndMarketingDate>20200701</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204595</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161228</StartMarketingDatePackage>
<EndMarketingDatePackage>20200701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49358-550-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (49358-550-01) > 35 g in 1 TUBE</PackageDescription>
<NDC11Code>49358-0550-01</NDC11Code>
<ProductNDC>49358-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Beauty Balm</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 50 Sunscreen Uva-uvb Suncreen Light/medium</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>50021-020-01</NDCCode>
<PackageDescription>550 mL in 1 BOTTLE, PUMP (50021-020-01) </PackageDescription>
<NDC11Code>50021-0020-01</NDC11Code>
<ProductNDC>50021-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Empack Spraytech Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use whensoap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50269-550-01</NDCCode>
<PackageDescription>20 POUCH in 1 BOX (50269-550-01) / 2 TABLET, FILM COATED in 1 POUCH</PackageDescription>
<NDC11Code>50269-0550-01</NDC11Code>
<ProductNDC>50269-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Cold Flu Severe</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>JC World Bell Wholesale Co., Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of the following cold/flu symptoms:. minor aches and pains . headache. sore throat. nasal congestion. cough. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50458-550-01</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01) </PackageDescription>
<NDC11Code>50458-0550-01</NDC11Code>
<ProductNDC>50458-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invega</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021999</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVEGA is an atypical antipsychotic agent indicated for. Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>INVEGA ® contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. INVEGA (paliperidone) Extended-Release Tablets are intended for oral administration and are available in 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. INVEGA utilizes OROS ® osmotic drug-release technology. Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethyl cellulose, propylene glycol, polyethylene glycol, polyethylene oxides, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>50742-550-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (50742-550-05) / 1 PATCH in 1 POUCH (50742-550-01) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>50742-0550-05</NDC11Code>
<ProductNDC>50742-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077449</ApplicationNumber>
<LabelerName>INGENUS PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1)] , reserve opioid analgesics, including fentanyl transdermal system for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2). The composition per unit area of all transdermal system sizes is identical. * Nominal delivery rate is 12.5 mcg/hour ** Nominal delivery rate per hour. The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22H 28N 2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal system is a rectangular transparent unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are. 1) a backing layer of polyethylene terephalate film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded.</Description>
</NDC>
<NDC>
<NDCCode>51021-582-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51021-582-01) * 150 mL in 1 BOTTLE (51021-250-05) * 30 mL in 1 BOTTLE, DROPPER (51021-550-30) </PackageDescription>
<NDC11Code>51021-0582-01</NDC11Code>
<ProductNDC>51021-582</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dynabac 5.0</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Cannabidiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190531</StartMarketingDate>
<EndMarketingDate>20210101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204132</ApplicationNumber>
<LabelerName>Sircle Laboratories, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190531</StartMarketingDatePackage>
<EndMarketingDatePackage>20210101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51407-550-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-550-01) </PackageDescription>
<NDC11Code>51407-0550-01</NDC11Code>
<ProductNDC>51407-550</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>3.75; 3.75; 3.75; 3.75</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>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>52268-550-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (52268-550-01) </PackageDescription>
<NDC11Code>52268-0550-01</NDC11Code>
<ProductNDC>52268-550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suflave</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230615</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215344</ApplicationNumber>
<LabelerName>Braintree Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<EndMarketingDatePackage>20280229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52854-550-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (52854-550-01)</PackageDescription>
<NDC11Code>52854-0550-01</NDC11Code>
<ProductNDC>52854-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Reef Babies Spf 50</ProprietaryName>
<NonProprietaryName>Octocrylene, Octisalate, Oxybenzone, And Avobenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Tropical Seas, Inc.</LabelerName>
<SubstanceName>OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE</SubstanceName>
<StrengthNumber>5; 5; 4; 2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53194-003-01</NDCCode>
<PackageDescription>550 kg in 1 CONTAINER (53194-003-01)</PackageDescription>
<NDC11Code>53194-0003-01</NDC11Code>
<ProductNDC>53194-003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Medium-chain Triglycerides</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20150918</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>IOI Oleo GmbH</LabelerName>
<SubstanceName>MEDIUM-CHAIN TRIGLYCERIDES</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53208-550-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (53208-550-02) > 13 g in 1 CONTAINER (53208-550-01)</PackageDescription>
<NDC11Code>53208-0550-02</NDC11Code>
<ProductNDC>53208-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohui Age Recovery Tri Shield Pact 10</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111011</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>LG Household and Healthcare, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>4.9; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54860-550-01</NDCCode>
<PackageDescription>28 mL in 1 BOTTLE, SPRAY (54860-550-01) </PackageDescription>
<NDC11Code>54860-0550-01</NDC11Code>
<ProductNDC>54860-550</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Hand Sanitizer Mermicorno</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260105</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
</NDC>
</NDCList>