{
"NDC": [
{
"NDCCode": "83021-553-60",
"PackageDescription": "60 mL in 1 JAR (83021-553-60) ",
"NDC11Code": "83021-0553-60",
"ProductNDC": "83021-553",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Dmae, Zirhafirm",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230113",
"EndMarketingDate": "20280306",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "ALOE VERA LEAF; LINALOOL, (+/-)-; EUGENOL; PROPANEDIOL; BENZYL ALCOHOL; CETOSTEARYL ALCOHOL; DICAPRYLYL ETHER; SORBIC ACID; XANTHAN GUM; .BETA.-CITRONELLOL, (R)-; GLYCERYL MONOSTEARATE; FRAGRANCE 13576; SALICYLIC ACID; JUJUBE SEED; LECITHIN, SOYBEAN; BAICALIN; LEUZEA CARTHAMOIDES ROOT; WATER; LIMONENE, (+)-; HYDROXYCITRONELLAL; TOCOPHEROL; GLYCERIN; DECYL OLEATE; SHEA BUTTER",
"StrengthNumber": "5.988; .0006; .0006; 2.496; .456; 1.2; 1.5; .024; .18; .0006; 2.4; .114; .09; .048; .036; .012; .012; 33.2616; .006; .0024; .0018; 3.036; 3.9; 2.1",
"StrengthUnit": "g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; mL/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Pediculicide [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230113",
"EndMarketingDatePackage": "20280306",
"SamplePackage": "N"
},
{
"NDCCode": "12634-553-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (12634-553-60)",
"NDC11Code": "12634-0553-60",
"ProductNDC": "12634-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19991108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040887",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "41520-553-02",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (41520-553-02) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "41520-0553-02",
"ProductNDC": "41520-553",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Childrens Allergy Relief",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20190823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "American Sales Company",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190823",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: : 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes ."
},
{
"NDCCode": "53462-553-60",
"PackageDescription": "1 KIT in 1 KIT (53462-553-60) * 1 TUBE in 1 KIT > 14 g in 1 TUBE * 8 PACKET in 1 KIT > 7 mL in 1 PACKET",
"NDC11Code": "53462-0553-60",
"ProductNDC": "53462-553",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Suction Swab System With Perox-a-mint Solution - Suction Swab And Suction Toothbrush",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20070630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Sage Products LLC",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20070630",
"SamplePackage": "N"
},
{
"NDCCode": "55648-553-04",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55648-553-04)",
"NDC11Code": "55648-0553-04",
"ProductNDC": "55648-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078871",
"LabelerName": "WOCKHARDT LIMITED",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "60760-553-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-553-60) ",
"NDC11Code": "60760-0553-60",
"ProductNDC": "60760-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180302",
"SamplePackage": "N"
},
{
"NDCCode": "63187-553-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (63187-553-60) ",
"NDC11Code": "63187-0553-60",
"ProductNDC": "63187-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202556",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2021-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate."
},
{
"NDCCode": "63874-553-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63874-553-60)",
"NDC11Code": "63874-0553-60",
"ProductNDC": "63874-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075410",
"LabelerName": "Altura Pharmaceuticals, Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Omeprazole Delayed-Release Capsules are a proton pump inhibitor indicated for: 1 Treatment of duodenal ulcer in adults (1.1), 2 Treatment of gastric ulcer in adults (1.2), 3 Treatment of gastroesophageal reflux disease (GERD) in pediatric patients and adults (1.3), 4 Maintenance of healing of erosive esophagitis in pediatric patients and adults (1.4), 5 Treatment of pathological hypersecretory conditions in adults (1.5).",
"Description": "The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules are for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, titanium dioxide, sodium lauryl sulfate, synthetic black iron oxide, shellac glaze, and other inactive ingredients. In addition, the 20 mg and 40 mg capsules shells also contain yellow iron oxide."
},
{
"NDCCode": "64679-553-04",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (64679-553-04) ",
"NDC11Code": "64679-0553-04",
"ProductNDC": "64679-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078871",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake."
},
{
"NDCCode": "68382-553-14",
"PackageDescription": "60 TABLET in 1 BOTTLE (68382-553-14) ",
"NDC11Code": "68382-0553-14",
"ProductNDC": "68382-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204189",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190115",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: : 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil tablets therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil tablets therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. , 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL TABLETS ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. .",
"Description": "Gemfibrozil tablets, USP is a lipid regulating agent. It is available as tablets for oral administration. The chemical name is 5-(2,5-dimethylphenoxy)2,2-dimethylpentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.33. It is soluble in alcohol, methanol and chloroform. The melting point is 58° to 61°C. Gemfibrozil is a white, waxy, crystalline solid which is stable under ordinary conditions. Each gemfibrozil tablet intended for oral administration contains 600 mg of gemfibrozil. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methyl cellulose and microcrystalline cellulose. Additionally each tablet contains opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "71610-553-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (71610-553-60) ",
"NDC11Code": "71610-0553-60",
"ProductNDC": "71610-553",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210504",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "76420-553-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (76420-553-60) ",
"NDC11Code": "76420-0553-60",
"ProductNDC": "76420-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209654",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230328",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is white to almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Tadalafil Tablets, USP are available as light yellow to yellow coloured oval shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium lauryl sulphate, low-substituted hydroxypropyl cellulose and magnesium stearate. The color coating contains hypromellose, titanium dioxide, lactose monohydrate, iron oxide yellow, triacetin and FD&C yellow #5/tartrazine aluminium lake."
},
{
"NDCCode": "83021-546-30",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (83021-546-30) ",
"NDC11Code": "83021-0546-30",
"ProductNDC": "83021-546",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Dmae",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230113",
"EndMarketingDate": "20270805",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "GLYCERIN; PHENOXYETHANOL; XANTHAN GUM; FRAGRANCE 13576; SORBITAN ISOSTEARATE; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); LIMONENE, (+)-; TOCOPHEROL; HYDROXYCITRONELLAL; POLYSORBATE 60; LECITHIN, SOYBEAN; HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%); DEHYDROACETIC ACID; PROPANEDIOL; DICAPRYLYL ETHER; BENZOIC ACID; ASCORBYL GLUCOSIDE; WATER",
"StrengthNumber": ".555; .243; .09; .027; .024; .0012; .0009; .0003; .0006; .024; .45; .405; .021; 1.08; .9; .036; .15; 25.5564",
"StrengthUnit": "g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; mL/30mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230113",
"EndMarketingDatePackage": "20270805",
"SamplePackage": "N"
},
{
"NDCCode": "16714-553-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-553-01) ",
"NDC11Code": "16714-0553-01",
"ProductNDC": "16714-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212317",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220623",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, water, sparingly soluble in dehydrated alcohol and insoluble in ether. It has a molecular weight of 450.98 g/mol. Each Diltiazem Hydrochloride Extended-Release Capsules, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: Diethyl phthalate, ethyl cellulose, methacrylic acid and ethyl acrylate copolymer, polysorbate, povidone, sodium lauryl sulfate, sugar spheres (corn starch, hypromellose and sucrose) and talc. The capsule shells contain D&C Yellow No. 10 (90 mg only), FD&C Red No. 3, FD&C Red No.40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The black printing ink contains black iron oxide, potassium hydroxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "43602-553-05",
"PackageDescription": "500 TABLET, CHEWABLE in 1 BOTTLE (43602-553-05) ",
"NDC11Code": "43602-0553-05",
"ProductNDC": "43602-553",
"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": "30",
"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": "43602-553-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (43602-553-30) ",
"NDC11Code": "43602-0553-30",
"ProductNDC": "43602-553",
"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": "30",
"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": "50419-385-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50419-0385-01",
"ProductNDC": "50419-385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aliqopa",
"NonProprietaryName": "Copanlisib",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170914",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209936",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "COPANLISIB",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170914",
"SamplePackage": "N",
"IndicationAndUsage": "ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. : 1 Accelerated approval was granted for this indication based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
"Description": "ALIQOPA (copanlisib) is a kinase inhibitor for intravenous infusion. The active pharmaceutical ingredient is copanlisib dihydrochloride which exists as a non-stoichiometric hydrate and has the molecular formula of C23H28N8O4 2HCl and a molecular weight of 553.45 g/mol. The molecular formula and molecular weight are based on the anhydrous form. The chemical name is 2-amino-N-{7-methoxy-8-[3-(morpholin-4-yl)propoxy]-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl}pyrimidine-5-carboxamide dihydrochloride. Copanlisib dihydrochloride has the following structural formula. ALIQOPA is supplied in single-dose vials as a sterile lyophilized solid for reconstitution and further dilution for intravenous infusion. The product is white to slightly yellowish. After reconstitution, the solution is colorless to slightly yellowish. Each vial contains 60 mg copanlisib free base (equivalent to 69.1 mg copanlisib dihydrochloride). After reconstitution, each mL contains 15 mg copanlisib free base (equivalent to 17.3 mg copanlisib dihydrochloride). Inactive ingredients: Each vial contains 5.8 mg citric acid anhydrous (might increase to 6.1 mg in case pH correction is necessary), 120 mg mannitol (bulking agent). Citric acid anhydrous acts as a buffering agent and may be used together with sodium hydroxide for pH adjustment."
},
{
"NDCCode": "50419-385-72",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-72) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50419-0385-72",
"ProductNDC": "50419-385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aliqopa",
"NonProprietaryName": "Copanlisib",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170914",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209936",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "COPANLISIB",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181030",
"SamplePackage": "Y",
"IndicationAndUsage": "ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. : 1 Accelerated approval was granted for this indication based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
"Description": "ALIQOPA (copanlisib) is a kinase inhibitor for intravenous infusion. The active pharmaceutical ingredient is copanlisib dihydrochloride which exists as a non-stoichiometric hydrate and has the molecular formula of C23H28N8O4 2HCl and a molecular weight of 553.45 g/mol. The molecular formula and molecular weight are based on the anhydrous form. The chemical name is 2-amino-N-{7-methoxy-8-[3-(morpholin-4-yl)propoxy]-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl}pyrimidine-5-carboxamide dihydrochloride. Copanlisib dihydrochloride has the following structural formula. ALIQOPA is supplied in single-dose vials as a sterile lyophilized solid for reconstitution and further dilution for intravenous infusion. The product is white to slightly yellowish. After reconstitution, the solution is colorless to slightly yellowish. Each vial contains 60 mg copanlisib free base (equivalent to 69.1 mg copanlisib dihydrochloride). After reconstitution, each mL contains 15 mg copanlisib free base (equivalent to 17.3 mg copanlisib dihydrochloride). Inactive ingredients: Each vial contains 5.8 mg citric acid anhydrous (might increase to 6.1 mg in case pH correction is necessary), 120 mg mannitol (bulking agent). Citric acid anhydrous acts as a buffering agent and may be used together with sodium hydroxide for pH adjustment."
},
{
"NDCCode": "50742-553-05",
"PackageDescription": "5 POUCH in 1 CARTON (50742-553-05) / 1 PATCH in 1 POUCH (50742-553-01) / 72 h in 1 PATCH",
"NDC11Code": "50742-0553-05",
"ProductNDC": "50742-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20250210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077449",
"LabelerName": "INGENUS PHARMACEUTICALS, LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "62.5",
"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": "20250210",
"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": "52187-553-08",
"PackageDescription": "237 mL in 1 BOTTLE (52187-553-08) ",
"NDC11Code": "52187-0553-08",
"ProductNDC": "52187-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfacetamide Sodium",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211006",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "KMM Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "98",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2022-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211006",
"SamplePackage": "N",
"IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).",
"Description": "Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "64850-553-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (64850-553-01) ",
"NDC11Code": "64850-0553-01",
"ProductNDC": "64850-553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218604",
"LabelerName": "Elite Laboratories, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]. .",
"Description": "Lisdexamfetamine Dimesylate Capsules, a CNS stimulant, are 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 C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL)."
},
{
"NDCCode": "83021-033-01",
"PackageDescription": "250 mL in 1 BOTTLE, SPRAY (83021-033-01) ",
"NDC11Code": "83021-0033-01",
"ProductNDC": "83021-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona New Even",
"NonProprietaryName": "Lactic Acid, Citric Acid, Glycolic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221013",
"EndMarketingDate": "20270113",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "FD&C BLUE NO. 1; LACTIC ACID; POLYOXYL 40 HYDROGENATED CASTOR OIL; TROLAMINE; .ALPHA.-HEXYLCINNAMALDEHYDE; LINALOOL, (+/-)-; BENZOIC ACID; PHENOXYETHANOL; GLYCOLIC ACID; WATER; ALLANTOIN; DEHYDROACETIC ACID; DIETHYLENE GLYCOL MONOETHYL ETHER; FRAGRANCE 13576; LIMONENE, (+)-; PROPYLENE GLYCOL",
"StrengthNumber": ".0005; 2.348125; 1.25; .5; .0150375; .0041025; .625; 2.5; 1.220625; 228.15635; .75; .25; .75; .075; .022755; 10.5",
"StrengthUnit": "g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; mL/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL",
"Pharm_Classes": "Acidifying Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221013",
"EndMarketingDatePackage": "20270113",
"SamplePackage": "N"
},
{
"NDCCode": "83021-064-01",
"PackageDescription": "200 mL in 1 TUBE (83021-064-01) ",
"NDC11Code": "83021-0064-01",
"ProductNDC": "83021-064",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Vital Line",
"NonProprietaryName": "Hydrolyzed Collagen",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230223",
"EndMarketingDate": "20261020",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "PHENOXYETHANOL; FRAGRANCE 13576; ETHYLHEXYLGLYCERIN; AVOBENZONE; .BETA.-SITOSTEROL; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); LINOLEIC ACID; TOCOPHEROL; MALVA SYLVESTRIS FLOWERING TOP; PAPAVER RHOEAS FLOWER; MEDIUM-CHAIN TRIGLYCERIDES; SHEA BUTTER; LINOLENIC ACID; POLYGLYCERYL-4 ISOSTEARATE; HEXYL LAURATE; WHITE WAX; HYDROGENATED CASTOR OIL; AMILOXATE; CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4); SQUALANE; WATER; GLYCERIN; CETEARYL ETHYLHEXANOATE",
"StrengthNumber": "1.8; .8; .2; 2; .01; .2; .16; .08; .06; .04; 34; 4; .04; 3; 2.7; 1; 4; 4; 3; .01; 125.88; 7; 4",
"StrengthUnit": "g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230223",
"EndMarketingDatePackage": "20261020",
"SamplePackage": "N"
},
{
"NDCCode": "83021-187-01",
"PackageDescription": "200 mL in 1 TUBE (83021-187-01) ",
"NDC11Code": "83021-0187-01",
"ProductNDC": "83021-187",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Vital Line",
"NonProprietaryName": "Hydrolyzed Elastin, Hydrolysed Collagen, Cocoglycerides",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221025",
"EndMarketingDate": "20261020",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "AVOBENZONE; PHENOXYETHANOL; FRAGRANCE 13576; DEHYDROACETIC ACID; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); OCTINOXATE; COCO-GLYCERIDES; GLYCERIN; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); CETOSTEARYL ALCOHOL; MEDIUM-CHAIN TRIGLYCERIDES; CETYL ALCOHOL; .ALPHA.-HEXYLCINNAMALDEHYDE; WATER; BENZOIC ACID; CENTAUREA CYANUS FLOWER; VIOLA ODORATA; LIMONENE, (+)-; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; .BETA.-CITRONELLOL, (R)-; ISOMETHYL-.ALPHA.-IONONE; BUTYLATED HYDROXYTOLUENE",
"StrengthNumber": "2; 1.62; .98; .14; .03; 5; 8; 6.94; .6; 12.58; 12; 4; .16; 140; .24; .05; .05; .038; .006; .0056; .0054; .005",
"StrengthUnit": "g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL",
"Pharm_Classes": "Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221025",
"EndMarketingDatePackage": "20261020",
"SamplePackage": "N"
},
{
"NDCCode": "83021-300-01",
"PackageDescription": "200 mL in 1 TUBE (83021-300-01) ",
"NDC11Code": "83021-0300-01",
"ProductNDC": "83021-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Regul Oil",
"NonProprietaryName": "Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (hops) Cone Extract",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221020",
"EndMarketingDate": "20280203",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "ANUBIS COSMETICS SL",
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"StrengthUnit": "g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221020",
"EndMarketingDatePackage": "20280203",
"SamplePackage": "N"
},
{
"NDCCode": "83021-305-50",
"PackageDescription": "50 mL in 1 TUBE (83021-305-50) ",
"NDC11Code": "83021-0305-50",
"ProductNDC": "83021-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Spa Line",
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"RouteName": "TOPICAL",
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"EndMarketingDate": "20271013",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
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"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221014",
"EndMarketingDatePackage": "20271013",
"SamplePackage": "N"
},
{
"NDCCode": "83021-400-50",
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"EndMarketingDate": "20270510",
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"StrengthUnit": "g/50mL; g/50mL; mL/50mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-07",
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"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20270510",
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},
{
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"RouteName": "TOPICAL",
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"EndMarketingDate": "20270701",
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"LabelerName": "ANUBIS COSMETICS SL",
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"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL",
"Pharm_Classes": "Acidifying Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221104",
"EndMarketingDatePackage": "20270701",
"SamplePackage": "N"
},
{
"NDCCode": "83021-402-50",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (83021-402-50) ",
"NDC11Code": "83021-0402-50",
"ProductNDC": "83021-402",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20221026",
"EndMarketingDate": "20270908",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "ANUBIS COSMETICS SL",
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"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; mL/50mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221026",
"EndMarketingDatePackage": "20270908",
"SamplePackage": "N"
},
{
"NDCCode": "83021-495-20",
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"NDC11Code": "83021-0495-20",
"ProductNDC": "83021-495",
"ProductTypeName": "HUMAN OTC DRUG",
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"EndMarketingDate": "20270902",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "ANUBIS COSMETICS SL",
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"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221025",
"EndMarketingDatePackage": "20270902",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>83021-553-60</NDCCode>
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<NDC11Code>83021-0553-60</NDC11Code>
<ProductNDC>83021-553</ProductNDC>
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<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<NDC11Code>12634-0553-60</NDC11Code>
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<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
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<LabelerName>Apotheca, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>41520-553-02</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (41520-553-02) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
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<ProductNDC>41520-553</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Childrens Allergy Relief</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
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<RouteName>NASAL</RouteName>
<StartMarketingDate>20190823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: : 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53462-553-60</NDCCode>
<PackageDescription>1 KIT in 1 KIT (53462-553-60) * 1 TUBE in 1 KIT > 14 g in 1 TUBE * 8 PACKET in 1 KIT > 7 mL in 1 PACKET</PackageDescription>
<NDC11Code>53462-0553-60</NDC11Code>
<ProductNDC>53462-553</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Suction Swab System With Perox-a-mint Solution - Suction Swab And Suction Toothbrush</ProprietaryName>
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<DosageFormName>KIT</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Sage Products LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55648-553-04</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55648-553-04)</PackageDescription>
<NDC11Code>55648-0553-04</NDC11Code>
<ProductNDC>55648-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078871</ApplicationNumber>
<LabelerName>WOCKHARDT LIMITED</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60760-553-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-553-60) </PackageDescription>
<NDC11Code>60760-0553-60</NDC11Code>
<ProductNDC>60760-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-553-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (63187-553-60) </PackageDescription>
<NDC11Code>63187-0553-60</NDC11Code>
<ProductNDC>63187-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202556</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>63874-553-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63874-553-60)</PackageDescription>
<NDC11Code>63874-0553-60</NDC11Code>
<ProductNDC>63874-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075410</ApplicationNumber>
<LabelerName>Altura Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Omeprazole Delayed-Release Capsules are a proton pump inhibitor indicated for: 1 Treatment of duodenal ulcer in adults (1.1), 2 Treatment of gastric ulcer in adults (1.2), 3 Treatment of gastroesophageal reflux disease (GERD) in pediatric patients and adults (1.3), 4 Maintenance of healing of erosive esophagitis in pediatric patients and adults (1.4), 5 Treatment of pathological hypersecretory conditions in adults (1.5).</IndicationAndUsage>
<Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules are for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, titanium dioxide, sodium lauryl sulfate, synthetic black iron oxide, shellac glaze, and other inactive ingredients. In addition, the 20 mg and 40 mg capsules shells also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>64679-553-04</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (64679-553-04) </PackageDescription>
<NDC11Code>64679-0553-04</NDC11Code>
<ProductNDC>64679-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078871</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>68382-553-14</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68382-553-14) </PackageDescription>
<NDC11Code>68382-0553-14</NDC11Code>
<ProductNDC>68382-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204189</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: : 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil tablets therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil tablets therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. , 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL TABLETS ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. .</IndicationAndUsage>
<Description>Gemfibrozil tablets, USP is a lipid regulating agent. It is available as tablets for oral administration. The chemical name is 5-(2,5-dimethylphenoxy)2,2-dimethylpentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.33. It is soluble in alcohol, methanol and chloroform. The melting point is 58° to 61°C. Gemfibrozil is a white, waxy, crystalline solid which is stable under ordinary conditions. Each gemfibrozil tablet intended for oral administration contains 600 mg of gemfibrozil. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methyl cellulose and microcrystalline cellulose. Additionally each tablet contains opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-553-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (71610-553-60) </PackageDescription>
<NDC11Code>71610-0553-60</NDC11Code>
<ProductNDC>71610-553</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-553-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (76420-553-60) </PackageDescription>
<NDC11Code>76420-0553-60</NDC11Code>
<ProductNDC>76420-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209654</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is white to almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Tadalafil Tablets, USP are available as light yellow to yellow coloured oval shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium lauryl sulphate, low-substituted hydroxypropyl cellulose and magnesium stearate. The color coating contains hypromellose, titanium dioxide, lactose monohydrate, iron oxide yellow, triacetin and FD&C yellow #5/tartrazine aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>83021-546-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (83021-546-30) </PackageDescription>
<NDC11Code>83021-0546-30</NDC11Code>
<ProductNDC>83021-546</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Dmae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230113</StartMarketingDate>
<EndMarketingDate>20270805</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>GLYCERIN; PHENOXYETHANOL; XANTHAN GUM; FRAGRANCE 13576; SORBITAN ISOSTEARATE; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); LIMONENE, (+)-; TOCOPHEROL; HYDROXYCITRONELLAL; POLYSORBATE 60; LECITHIN, SOYBEAN; HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%); DEHYDROACETIC ACID; PROPANEDIOL; DICAPRYLYL ETHER; BENZOIC ACID; ASCORBYL GLUCOSIDE; WATER</SubstanceName>
<StrengthNumber>.555; .243; .09; .027; .024; .0012; .0009; .0003; .0006; .024; .45; .405; .021; 1.08; .9; .036; .15; 25.5564</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; mL/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230113</StartMarketingDatePackage>
<EndMarketingDatePackage>20270805</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-553-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-553-01) </PackageDescription>
<NDC11Code>16714-0553-01</NDC11Code>
<ProductNDC>16714-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212317</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, water, sparingly soluble in dehydrated alcohol and insoluble in ether. It has a molecular weight of 450.98 g/mol. Each Diltiazem Hydrochloride Extended-Release Capsules, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: Diethyl phthalate, ethyl cellulose, methacrylic acid and ethyl acrylate copolymer, polysorbate, povidone, sodium lauryl sulfate, sugar spheres (corn starch, hypromellose and sucrose) and talc. The capsule shells contain D&C Yellow No. 10 (90 mg only), FD&C Red No. 3, FD&C Red No.40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The black printing ink contains black iron oxide, potassium hydroxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43602-553-05</NDCCode>
<PackageDescription>500 TABLET, CHEWABLE in 1 BOTTLE (43602-553-05) </PackageDescription>
<NDC11Code>43602-0553-05</NDC11Code>
<ProductNDC>43602-553</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>30</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>43602-553-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (43602-553-30) </PackageDescription>
<NDC11Code>43602-0553-30</NDC11Code>
<ProductNDC>43602-553</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>30</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>50419-385-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50419-0385-01</NDC11Code>
<ProductNDC>50419-385</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aliqopa</ProprietaryName>
<NonProprietaryName>Copanlisib</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170914</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209936</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>COPANLISIB</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. : 1 Accelerated approval was granted for this indication based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.</IndicationAndUsage>
<Description>ALIQOPA (copanlisib) is a kinase inhibitor for intravenous infusion. The active pharmaceutical ingredient is copanlisib dihydrochloride which exists as a non-stoichiometric hydrate and has the molecular formula of C23H28N8O4 2HCl and a molecular weight of 553.45 g/mol. The molecular formula and molecular weight are based on the anhydrous form. The chemical name is 2-amino-N-{7-methoxy-8-[3-(morpholin-4-yl)propoxy]-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl}pyrimidine-5-carboxamide dihydrochloride. Copanlisib dihydrochloride has the following structural formula. ALIQOPA is supplied in single-dose vials as a sterile lyophilized solid for reconstitution and further dilution for intravenous infusion. The product is white to slightly yellowish. After reconstitution, the solution is colorless to slightly yellowish. Each vial contains 60 mg copanlisib free base (equivalent to 69.1 mg copanlisib dihydrochloride). After reconstitution, each mL contains 15 mg copanlisib free base (equivalent to 17.3 mg copanlisib dihydrochloride). Inactive ingredients: Each vial contains 5.8 mg citric acid anhydrous (might increase to 6.1 mg in case pH correction is necessary), 120 mg mannitol (bulking agent). Citric acid anhydrous acts as a buffering agent and may be used together with sodium hydroxide for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>50419-385-72</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-72) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50419-0385-72</NDC11Code>
<ProductNDC>50419-385</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aliqopa</ProprietaryName>
<NonProprietaryName>Copanlisib</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170914</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209936</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>COPANLISIB</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181030</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. : 1 Accelerated approval was granted for this indication based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.</IndicationAndUsage>
<Description>ALIQOPA (copanlisib) is a kinase inhibitor for intravenous infusion. The active pharmaceutical ingredient is copanlisib dihydrochloride which exists as a non-stoichiometric hydrate and has the molecular formula of C23H28N8O4 2HCl and a molecular weight of 553.45 g/mol. The molecular formula and molecular weight are based on the anhydrous form. The chemical name is 2-amino-N-{7-methoxy-8-[3-(morpholin-4-yl)propoxy]-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl}pyrimidine-5-carboxamide dihydrochloride. Copanlisib dihydrochloride has the following structural formula. ALIQOPA is supplied in single-dose vials as a sterile lyophilized solid for reconstitution and further dilution for intravenous infusion. The product is white to slightly yellowish. After reconstitution, the solution is colorless to slightly yellowish. Each vial contains 60 mg copanlisib free base (equivalent to 69.1 mg copanlisib dihydrochloride). After reconstitution, each mL contains 15 mg copanlisib free base (equivalent to 17.3 mg copanlisib dihydrochloride). Inactive ingredients: Each vial contains 5.8 mg citric acid anhydrous (might increase to 6.1 mg in case pH correction is necessary), 120 mg mannitol (bulking agent). Citric acid anhydrous acts as a buffering agent and may be used together with sodium hydroxide for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>50742-553-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (50742-553-05) / 1 PATCH in 1 POUCH (50742-553-01) / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>50742-0553-05</NDC11Code>
<ProductNDC>50742-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20250210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077449</ApplicationNumber>
<LabelerName>INGENUS PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>62.5</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>20250210</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>52187-553-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (52187-553-08) </PackageDescription>
<NDC11Code>52187-0553-08</NDC11Code>
<ProductNDC>52187-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfacetamide Sodium</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211006</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>KMM Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>98</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).</IndicationAndUsage>
<Description>Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>64850-553-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (64850-553-01) </PackageDescription>
<NDC11Code>64850-0553-01</NDC11Code>
<ProductNDC>64850-553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218604</ApplicationNumber>
<LabelerName>Elite Laboratories, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>Lisdexamfetamine Dimesylate Capsules, a CNS stimulant, are 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 C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL).</Description>
</NDC>
<NDC>
<NDCCode>83021-033-01</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, SPRAY (83021-033-01) </PackageDescription>
<NDC11Code>83021-0033-01</NDC11Code>
<ProductNDC>83021-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona New Even</ProprietaryName>
<NonProprietaryName>Lactic Acid, Citric Acid, Glycolic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221013</StartMarketingDate>
<EndMarketingDate>20270113</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>FD&C BLUE NO. 1; LACTIC ACID; POLYOXYL 40 HYDROGENATED CASTOR OIL; TROLAMINE; .ALPHA.-HEXYLCINNAMALDEHYDE; LINALOOL, (+/-)-; BENZOIC ACID; PHENOXYETHANOL; GLYCOLIC ACID; WATER; ALLANTOIN; DEHYDROACETIC ACID; DIETHYLENE GLYCOL MONOETHYL ETHER; FRAGRANCE 13576; LIMONENE, (+)-; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.0005; 2.348125; 1.25; .5; .0150375; .0041025; .625; 2.5; 1.220625; 228.15635; .75; .25; .75; .075; .022755; 10.5</StrengthNumber>
<StrengthUnit>g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; mL/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221013</StartMarketingDatePackage>
<EndMarketingDatePackage>20270113</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-064-01</NDCCode>
<PackageDescription>200 mL in 1 TUBE (83021-064-01) </PackageDescription>
<NDC11Code>83021-0064-01</NDC11Code>
<ProductNDC>83021-064</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Vital Line</ProprietaryName>
<NonProprietaryName>Hydrolyzed Collagen</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230223</StartMarketingDate>
<EndMarketingDate>20261020</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>PHENOXYETHANOL; FRAGRANCE 13576; ETHYLHEXYLGLYCERIN; AVOBENZONE; .BETA.-SITOSTEROL; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); LINOLEIC ACID; TOCOPHEROL; MALVA SYLVESTRIS FLOWERING TOP; PAPAVER RHOEAS FLOWER; MEDIUM-CHAIN TRIGLYCERIDES; SHEA BUTTER; LINOLENIC ACID; POLYGLYCERYL-4 ISOSTEARATE; HEXYL LAURATE; WHITE WAX; HYDROGENATED CASTOR OIL; AMILOXATE; CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4); SQUALANE; WATER; GLYCERIN; CETEARYL ETHYLHEXANOATE</SubstanceName>
<StrengthNumber>1.8; .8; .2; 2; .01; .2; .16; .08; .06; .04; 34; 4; .04; 3; 2.7; 1; 4; 4; 3; .01; 125.88; 7; 4</StrengthNumber>
<StrengthUnit>g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230223</StartMarketingDatePackage>
<EndMarketingDatePackage>20261020</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-187-01</NDCCode>
<PackageDescription>200 mL in 1 TUBE (83021-187-01) </PackageDescription>
<NDC11Code>83021-0187-01</NDC11Code>
<ProductNDC>83021-187</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Vital Line</ProprietaryName>
<NonProprietaryName>Hydrolyzed Elastin, Hydrolysed Collagen, Cocoglycerides</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221025</StartMarketingDate>
<EndMarketingDate>20261020</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>AVOBENZONE; PHENOXYETHANOL; FRAGRANCE 13576; DEHYDROACETIC ACID; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); OCTINOXATE; COCO-GLYCERIDES; GLYCERIN; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); CETOSTEARYL ALCOHOL; MEDIUM-CHAIN TRIGLYCERIDES; CETYL ALCOHOL; .ALPHA.-HEXYLCINNAMALDEHYDE; WATER; BENZOIC ACID; CENTAUREA CYANUS FLOWER; VIOLA ODORATA; LIMONENE, (+)-; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; .BETA.-CITRONELLOL, (R)-; ISOMETHYL-.ALPHA.-IONONE; BUTYLATED HYDROXYTOLUENE</SubstanceName>
<StrengthNumber>2; 1.62; .98; .14; .03; 5; 8; 6.94; .6; 12.58; 12; 4; .16; 140; .24; .05; .05; .038; .006; .0056; .0054; .005</StrengthNumber>
<StrengthUnit>g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221025</StartMarketingDatePackage>
<EndMarketingDatePackage>20261020</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-300-01</NDCCode>
<PackageDescription>200 mL in 1 TUBE (83021-300-01) </PackageDescription>
<NDC11Code>83021-0300-01</NDC11Code>
<ProductNDC>83021-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Regul Oil</ProprietaryName>
<NonProprietaryName>Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (hops) Cone Extract</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221020</StartMarketingDate>
<EndMarketingDate>20280203</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>ARCTIUM LAPPA ROOT; POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE); LAURETH-7; PEG/PPG-20/6 DIMETHICONE; ALCOHOL; GLYCERIN; CETEARYL ETHYLHEXANOATE; LIMONENE, (+)-; PANTHENOL; IMIDUREA; FD&C YELLOW NO. 5; RIBOFLAVIN; PHENOXYETHANOL; FRAGRANCE 13576; WATER; CETOSTEARYL ALCOHOL; PROPYLENE GLYCOL; MINERAL OIL; ETHYLHEXYLGLYCERIN; METHYLCHLOROISOTHIAZOLINONE; METHYLISOTHIAZOLINONE; HOPS; TIOXOLONE; PROPYLPARABEN; YEAST, UNSPECIFIED; NIACINAMIDE; C13-14 ISOPARAFFIN; METHYLPARABEN; GLYCERYL STEARATE SE; TRIISOPROPANOLAMINE; PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)</SubstanceName>
<StrengthNumber>.012; .8; .12; 1.372; .08; .048; 4; .08398; .1; .6; .00004; .00012; .0252; .6; 123.55598; 26; 10.148; 6; .0028; .045; .15; .0012; .3; .24; .023; .023; .48; .48; 7; .004; .0012</StrengthNumber>
<StrengthUnit>g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221020</StartMarketingDatePackage>
<EndMarketingDatePackage>20280203</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-305-50</NDCCode>
<PackageDescription>50 mL in 1 TUBE (83021-305-50) </PackageDescription>
<NDC11Code>83021-0305-50</NDC11Code>
<ProductNDC>83021-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Spa Line</ProprietaryName>
<NonProprietaryName>Oryza Sativa (rice) Starch, Perlite, Palmitic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221014</StartMarketingDate>
<EndMarketingDate>20271013</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>FRAGRANCE 13576; GRAPE SEED OIL; GLYCERYL MONOSTEARATE; LINALOOL, (+/-)-; PHENOXYETHANOL; PROPYLENE GLYCOL; TITANIUM DIOXIDE; PALMITIC ACID; BUTYLATED HYDROXYTOLUENE; STARCH, RICE; ALCOHOL; C12-20 ACID PEG-8 ESTER; TROLAMINE; ISOMETHYL-.ALPHA.-IONONE; HYDROXYACETOPHENONE; PERLITE; GLYCERIN; ETHYLHEXYLGLYCERIN; .BETA.-CITRONELLOL, (R)-; WATER; STEARIC ACID; CETEARYL ETHYLHEXANOATE</SubstanceName>
<StrengthNumber>.15; .25; 3.5; .0114; .45; 1.5; .25; 1; .25; 5.5; 4.752; 1; .25; .00639; .25; 4; .0115; .05; .012; 25.04945; 1; .75</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; 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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221014</StartMarketingDatePackage>
<EndMarketingDatePackage>20271013</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-400-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, SPRAY (83021-400-50) </PackageDescription>
<NDC11Code>83021-0400-50</NDC11Code>
<ProductNDC>83021-400</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubismed</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate, Aloe Barbadensis Leaf Juice, Imidazolidinyl Urea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221026</StartMarketingDate>
<EndMarketingDate>20270510</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>IMIDUREA; ALOE VERA LEAF; WATER</SubstanceName>
<StrengthNumber>.25; .15; 45.8293</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; mL/50mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221026</StartMarketingDatePackage>
<EndMarketingDatePackage>20270510</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-401-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (83021-401-50) </PackageDescription>
<NDC11Code>83021-0401-50</NDC11Code>
<ProductNDC>83021-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubismed</ProprietaryName>
<NonProprietaryName>Glycolic Acid, Citric Acid, Lactic Acid, Kojic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221104</StartMarketingDate>
<EndMarketingDate>20270701</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>GLYCOLIC ACID; KOJIC ACID; HEXYLRESORCINOL; ASCORBYL GLUCOSIDE; LACTIC ACID; PHENOXYETHANOL; PROPYLENE GLYCOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ALCOHOL; AMMONIA; ISOPROPYL ALCOHOL; WATER; ETHYLHEXYLGLYCERIN; SALICYLIC ACID</SubstanceName>
<StrengthNumber>17; 2.5; 1; .25; 5; .225; .5; .34875; 6.3; 2.75; .75; 7.333; .025; 1</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221104</StartMarketingDatePackage>
<EndMarketingDatePackage>20270701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-402-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (83021-402-50) </PackageDescription>
<NDC11Code>83021-0402-50</NDC11Code>
<ProductNDC>83021-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubismed</ProprietaryName>
<NonProprietaryName>Azelaic Acid, Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221026</StartMarketingDate>
<EndMarketingDate>20270908</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>AZELAIC ACID; POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL; ISOPROPYL ALCOHOL; WATER; SALICYLIC ACID; ALCOHOL</SubstanceName>
<StrengthNumber>7; 4.9965; 10; 2.7; 1.62; 1; 22.68</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; mL/50mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221026</StartMarketingDatePackage>
<EndMarketingDatePackage>20270908</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-495-20</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, DROPPER (83021-495-20) </PackageDescription>
<NDC11Code>83021-0495-20</NDC11Code>
<ProductNDC>83021-495</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Proteoglycan, Glycerin, Butylene Glycol</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221025</StartMarketingDate>
<EndMarketingDate>20270902</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>PHENOXYETHANOL; XANTHAN GUM; BENZOIC ACID; WATER; BUTYLENE GLYCOL; PROPANEDIOL; POLYSORBATE 20; EDETIC ACID; PROTEOGLYCAN 4; FRAGRANCE 13576; GLYCERIN; DEHYDROACETIC ACID</SubstanceName>
<StrengthNumber>.162; .08; .024; 16.4578; .46; .4; .2; .0002; .002; .03; 2; .014</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL; g/20mL; mL/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221025</StartMarketingDatePackage>
<EndMarketingDatePackage>20270902</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>