{
"NDC": [
{
"NDCCode": "66336-570-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (66336-570-14)",
"NDC11Code": "66336-0570-14",
"ProductNDC": "66336-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076077",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole is the first of a new subclass of synthetic triazole antifungal agents. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C13H12F2N6O M.W. 306.3. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc."
},
{
"NDCCode": "66336-570-11",
"PackageDescription": "11 TABLET in 1 BOTTLE (66336-570-11)",
"NDC11Code": "66336-0570-11",
"ProductNDC": "66336-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076077",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole is the first of a new subclass of synthetic triazole antifungal agents. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C13H12F2N6O M.W. 306.3. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc."
},
{
"NDCCode": "50474-570-12",
"PackageDescription": "5 CARTON in 1 CARTON (50474-570-12) > 2 BLISTER PACK in 1 CARTON > 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50474-0570-12",
"ProductNDC": "50474-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Briviact",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205836",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2019-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160512",
"SamplePackage": "N"
},
{
"NDCCode": "50474-570-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50474-570-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50474-0570-14",
"ProductNDC": "50474-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Briviact",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205836",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160512",
"SamplePackage": "Y",
"IndicationAndUsage": "BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.",
"Description": "The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection."
},
{
"NDCCode": "63776-570-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-570-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0570-14",
"ProductNDC": "63776-570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-virus",
"NonProprietaryName": "Acidum Phosphoricum, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium, Hydrastis, Iodium, Lachesis, Lycopodium, Nastrutium, Nux Vomica, Phosphorus, Pyrogenium, Selenium, Spleen, Thymus, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ATROPA BELLADONNA; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM WHOLE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; SELENIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TROPAEOLUM MAJUS; ZINC",
"StrengthNumber": "12; 6; 6; 3; 12; 12; 3; 12; 12; 12; 12; 12; 30; 12; 12; 6; 6; 3; 12",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190719",
"SamplePackage": "N",
"IndicationAndUsage": "Viral conditions, cold and flu symptoms, Immune support and enhancer.",
"Description": "Viatrexx-Virus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "68462-570-78",
"PackageDescription": "1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE",
"NDC11Code": "68462-0570-78",
"ProductNDC": "68462-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20201006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210309",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl Fumarate Delayed-Release Capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is sparingly soluble in methanol; insoluble in water with a molecular mass of 144.13. Dimethyl Fumarate Delayed-Release Capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: croscarmellose sodium, hydrophobic colloidal silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, methacrylic acid copolymer dispersion (Eudragit L30 D-55), microcrystalline cellulose, simethicone (30% emulsion), talc and triethyl citrate. Eudragit L30 D-55 has the following ingredients: copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulphate, polysorbate 80 and purified water. The capsule shell for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg contains gelatin, titanium dioxide, FD&C blue 1, iron oxide yellow and iron oxide black. The imprinting ink for Dimethyl Fumarate Delayed-Release Capsule, 120 mg and 240 mg has the following components: black iron oxide, potassium hydroxide, and shellac."
},
{
"NDCCode": "66336-012-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (66336-012-14)",
"NDC11Code": "66336-0012-14",
"ProductNDC": "66336-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040144",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-115-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (66336-115-14)",
"NDC11Code": "66336-0115-14",
"ProductNDC": "66336-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040656",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-184-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (66336-184-14)",
"NDC11Code": "66336-0184-14",
"ProductNDC": "66336-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040412",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrochlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is 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. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral use. Each tablet contains the following inactive ingredients: FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch."
},
{
"NDCCode": "66336-185-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (66336-185-14)",
"NDC11Code": "66336-0185-14",
"ProductNDC": "66336-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040875",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.",
"Description": "Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake."
},
{
"NDCCode": "66336-336-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (66336-336-14)",
"NDC11Code": "66336-0336-14",
"ProductNDC": "66336-336",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077946",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat ."
},
{
"NDCCode": "66336-344-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (66336-344-14)",
"NDC11Code": "66336-0344-14",
"ProductNDC": "66336-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040527",
"LabelerName": "Dispensing Solutions, 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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e. g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows; pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride USP has the chemical name of α, α-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide."
},
{
"NDCCode": "66336-377-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (66336-377-14)",
"NDC11Code": "66336-0377-14",
"ProductNDC": "66336-377",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19911230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063065",
"LabelerName": "Dispensing Solution, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydia psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Calymmatobacterium granulomatis.",
"Description": "Minocycline hydrochloride is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn). The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 100 mg capsule shell also contains black iron oxide."
},
{
"NDCCode": "66336-442-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (66336-442-14)",
"NDC11Code": "66336-0442-14",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-554-14",
"PackageDescription": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (66336-554-14)",
"NDC11Code": "66336-0554-14",
"ProductNDC": "66336-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orphenadrine Citrate",
"NonProprietaryName": "Orphenadrine Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19980619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040284",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "ORPHENADRINE CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.",
"Description": "Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-〈-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NOC6H8O7 and molecular weight of 461.51. It has the following structural formula. Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "66336-560-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (66336-560-14)",
"NDC11Code": "66336-0560-14",
"ProductNDC": "66336-560",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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": "66336-620-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (66336-620-14)",
"NDC11Code": "66336-0620-14",
"ProductNDC": "66336-620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071523",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Trazodone Hydrochloride Tablets USP are indicated for the treatment of depression. The efficacy of Trazodone Hydrochloride Tablets USP has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, lll.a. Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.",
"Description": "Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "0078-0698-19",
"PackageDescription": "4 CARTON in 1 CARTON (0078-0698-19) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) ",
"NDC11Code": "00078-0698-19",
"ProductNDC": "0078-0698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rydapt",
"NonProprietaryName": "Rydapt",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207997",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "MIDOSTAURIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"IndicationAndUsage": "RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).",
"Description": "Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E."
},
{
"NDCCode": "0078-0698-99",
"PackageDescription": "2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) ",
"NDC11Code": "00078-0698-99",
"ProductNDC": "0078-0698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rydapt",
"NonProprietaryName": "Rydapt",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207997",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "MIDOSTAURIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"IndicationAndUsage": "RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).",
"Description": "Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E."
},
{
"NDCCode": "42291-570-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-570-90) ",
"NDC11Code": "42291-0570-90",
"ProductNDC": "42291-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207515",
"LabelerName": "AvKARE",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180724",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride (HCl) extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65 [see Clinical Studies (14)] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "Methylphenidate HCl extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate HCl extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl, USP is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release tablets, USP also contains the following inert ingredients: colloidal silicon dioxide, ethylcellulose, fumaric acid, hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium chloride, stearic acid, talc, titanium dioxide and triethyl citrate. The 18 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 27 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 54 mg extended-release tablet also contains iron oxide red. USP dissolution test is pending."
},
{
"NDCCode": "43063-570-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-21) ",
"NDC11Code": "43063-0570-21",
"ProductNDC": "43063-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20280229",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "43063-570-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-28) ",
"NDC11Code": "43063-0570-28",
"ProductNDC": "43063-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160127",
"EndMarketingDatePackage": "20280229",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "43063-570-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-30) ",
"NDC11Code": "43063-0570-30",
"ProductNDC": "43063-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150414",
"EndMarketingDatePackage": "20280229",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "43063-570-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-90) ",
"NDC11Code": "43063-0570-90",
"ProductNDC": "43063-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150414",
"EndMarketingDatePackage": "20280229",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "43386-570-01",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (43386-570-01) ",
"NDC11Code": "43386-0570-01",
"ProductNDC": "43386-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204115",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150406",
"SamplePackage": "N",
"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.",
"Description": "Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid."
},
{
"NDCCode": "53097-570-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (53097-570-60) > 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "53097-0570-60",
"ProductNDC": "53097-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marinol",
"NonProprietaryName": "Dronabinol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018651",
"LabelerName": "ThePharmaNetwork, LLC",
"SubstanceName": "DRONABINOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cannabinoid [EPC], Cannabinoids [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170510",
"SamplePackage": "N",
"IndicationAndUsage": "MARINOL is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.",
"Description": "Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C21H30O2 (molecular weight = 314.46) Dronabinol, the active ingredient in MARINOL (dronabinol capsules, USP), is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Each MARINOL capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide."
},
{
"NDCCode": "54838-570-59",
"PackageDescription": "150 mL in 1 BOTTLE, PLASTIC (54838-570-59) ",
"NDC11Code": "54838-0570-59",
"ProductNDC": "54838-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204171",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150817",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole Oral Solution is indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)], 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)], 3 Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)], 4 Treatment of Tourette’s Disorder [see Clinical Studies (14.5)].",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Oral Solution. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include butylated hydroxyanisole, methylparaben, phosphoric acid, propylene glycol, propylparaben, sodium hydroxide, sucralose, and purified water. The oral solution is orange flavored."
},
{
"NDCCode": "54838-570-70",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (54838-570-70) ",
"NDC11Code": "54838-0570-70",
"ProductNDC": "54838-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204171",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150817",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole Oral Solution is indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)], 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)], 3 Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)], 4 Treatment of Tourette’s Disorder [see Clinical Studies (14.5)].",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Oral Solution. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include butylated hydroxyanisole, methylparaben, phosphoric acid, propylene glycol, propylparaben, sodium hydroxide, sucralose, and purified water. The oral solution is orange flavored."
},
{
"NDCCode": "58468-0050-1",
"PackageDescription": "1 VIAL in 1 CARTON (58468-0050-1) / 5.1 mL in 1 VIAL",
"NDC11Code": "58468-0050-01",
"ProductNDC": "58468-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xenpozyme",
"NonProprietaryName": "Olipudase Alfa-rpcp",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761261",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "OLIPUDASE ALFA",
"StrengthNumber": "20",
"StrengthUnit": "mg/5.1mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220829",
"SamplePackage": "N",
"IndicationAndUsage": "XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.",
"Description": "Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution."
},
{
"NDCCode": "58468-0051-1",
"PackageDescription": "1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL",
"NDC11Code": "58468-0051-01",
"ProductNDC": "58468-0051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xenpozyme",
"NonProprietaryName": "Olipudase Alfa-rpcp",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761261",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "OLIPUDASE ALFA",
"StrengthNumber": "4",
"StrengthUnit": "mg/1.1mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220829",
"SamplePackage": "N",
"IndicationAndUsage": "XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.",
"Description": "Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>66336-570-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (66336-570-14)</PackageDescription>
<NDC11Code>66336-0570-14</NDC11Code>
<ProductNDC>66336-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076077</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole is the first of a new subclass of synthetic triazole antifungal agents. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C13H12F2N6O M.W. 306.3. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>66336-570-11</NDCCode>
<PackageDescription>11 TABLET in 1 BOTTLE (66336-570-11)</PackageDescription>
<NDC11Code>66336-0570-11</NDC11Code>
<ProductNDC>66336-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076077</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole is the first of a new subclass of synthetic triazole antifungal agents. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol and has the following structural formula. C13H12F2N6O M.W. 306.3. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets, for oral administration, contain 50, 100, 150, or 200 mg of fluconazole and have the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>50474-570-12</NDCCode>
<PackageDescription>5 CARTON in 1 CARTON (50474-570-12) > 2 BLISTER PACK in 1 CARTON > 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50474-0570-12</NDC11Code>
<ProductNDC>50474-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Briviact</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205836</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50474-570-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50474-570-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50474-0570-14</NDC11Code>
<ProductNDC>50474-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Briviact</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205836</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160512</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.</IndicationAndUsage>
<Description>The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>63776-570-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-570-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0570-14</NDC11Code>
<ProductNDC>63776-570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-virus</ProprietaryName>
<NonProprietaryName>Acidum Phosphoricum, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium, Hydrastis, Iodium, Lachesis, Lycopodium, Nastrutium, Nux Vomica, Phosphorus, Pyrogenium, Selenium, Spleen, Thymus, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM WHOLE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; SELENIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TROPAEOLUM MAJUS; ZINC</SubstanceName>
<StrengthNumber>12; 6; 6; 3; 12; 12; 3; 12; 12; 12; 12; 12; 30; 12; 12; 6; 6; 3; 12</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Viral conditions, cold and flu symptoms, Immune support and enhancer.</IndicationAndUsage>
<Description>Viatrexx-Virus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>68462-570-78</NDCCode>
<PackageDescription>1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0570-78</NDC11Code>
<ProductNDC>68462-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210309</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl Fumarate Delayed-Release Capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is sparingly soluble in methanol; insoluble in water with a molecular mass of 144.13. Dimethyl Fumarate Delayed-Release Capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: croscarmellose sodium, hydrophobic colloidal silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, methacrylic acid copolymer dispersion (Eudragit L30 D-55), microcrystalline cellulose, simethicone (30% emulsion), talc and triethyl citrate. Eudragit L30 D-55 has the following ingredients: copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulphate, polysorbate 80 and purified water. The capsule shell for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg contains gelatin, titanium dioxide, FD&C blue 1, iron oxide yellow and iron oxide black. The imprinting ink for Dimethyl Fumarate Delayed-Release Capsule, 120 mg and 240 mg has the following components: black iron oxide, potassium hydroxide, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>66336-012-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (66336-012-14)</PackageDescription>
<NDC11Code>66336-0012-14</NDC11Code>
<ProductNDC>66336-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040144</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-115-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (66336-115-14)</PackageDescription>
<NDC11Code>66336-0115-14</NDC11Code>
<ProductNDC>66336-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040656</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-184-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (66336-184-14)</PackageDescription>
<NDC11Code>66336-0184-14</NDC11Code>
<ProductNDC>66336-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040412</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrochlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is 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. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral use. Each tablet contains the following inactive ingredients: FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>66336-185-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (66336-185-14)</PackageDescription>
<NDC11Code>66336-0185-14</NDC11Code>
<ProductNDC>66336-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040875</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake.</Description>
</NDC>
<NDC>
<NDCCode>66336-336-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (66336-336-14)</PackageDescription>
<NDC11Code>66336-0336-14</NDC11Code>
<ProductNDC>66336-336</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077946</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-344-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (66336-344-14)</PackageDescription>
<NDC11Code>66336-0344-14</NDC11Code>
<ProductNDC>66336-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040527</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e. g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows; pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride USP has the chemical name of α, α-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>66336-377-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (66336-377-14)</PackageDescription>
<NDC11Code>66336-0377-14</NDC11Code>
<ProductNDC>66336-377</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063065</ApplicationNumber>
<LabelerName>Dispensing Solution, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydia psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Calymmatobacterium granulomatis.</IndicationAndUsage>
<Description>Minocycline hydrochloride is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn). The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 100 mg capsule shell also contains black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>66336-442-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (66336-442-14)</PackageDescription>
<NDC11Code>66336-0442-14</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-554-14</NDCCode>
<PackageDescription>14 TABLET, EXTENDED RELEASE in 1 BOTTLE (66336-554-14)</PackageDescription>
<NDC11Code>66336-0554-14</NDC11Code>
<ProductNDC>66336-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orphenadrine Citrate</ProprietaryName>
<NonProprietaryName>Orphenadrine Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040284</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>ORPHENADRINE CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.</IndicationAndUsage>
<Description>Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-〈-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NOC6H8O7 and molecular weight of 461.51. It has the following structural formula. Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>66336-560-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (66336-560-14)</PackageDescription>
<NDC11Code>66336-0560-14</NDC11Code>
<ProductNDC>66336-560</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<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>66336-620-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (66336-620-14)</PackageDescription>
<NDC11Code>66336-0620-14</NDC11Code>
<ProductNDC>66336-620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071523</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Trazodone Hydrochloride Tablets USP are indicated for the treatment of depression. The efficacy of Trazodone Hydrochloride Tablets USP has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, lll.a. Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.</IndicationAndUsage>
<Description>Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0078-0698-19</NDCCode>
<PackageDescription>4 CARTON in 1 CARTON (0078-0698-19) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) </PackageDescription>
<NDC11Code>00078-0698-19</NDC11Code>
<ProductNDC>0078-0698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rydapt</ProprietaryName>
<NonProprietaryName>Rydapt</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207997</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>MIDOSTAURIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).</IndicationAndUsage>
<Description>Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E.</Description>
</NDC>
<NDC>
<NDCCode>0078-0698-99</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02) </PackageDescription>
<NDC11Code>00078-0698-99</NDC11Code>
<ProductNDC>0078-0698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rydapt</ProprietaryName>
<NonProprietaryName>Rydapt</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207997</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>MIDOSTAURIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: 1 Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML., 2 Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2).</IndicationAndUsage>
<Description>Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide, N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3′,2′,1′-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methyl-. The chemical structure of midostaurin is shown below. RYDAPT is supplied as a soft capsule containing 25 mg of midostaurin. The capsule contains carmine, corn oil mono-di-triglycerides, dehydrated alcohol, ferric oxide red, ferric oxide yellow, gelatin, glycerin 85%, hypromellose 2910, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, propylene glycol, purified water, titanium dioxide, and vitamin E.</Description>
</NDC>
<NDC>
<NDCCode>42291-570-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-570-90) </PackageDescription>
<NDC11Code>42291-0570-90</NDC11Code>
<ProductNDC>42291-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207515</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>36</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>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride (HCl) extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65 [see Clinical Studies (14)] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>Methylphenidate HCl extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate HCl extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl, USP is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release tablets, USP also contains the following inert ingredients: colloidal silicon dioxide, ethylcellulose, fumaric acid, hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium chloride, stearic acid, talc, titanium dioxide and triethyl citrate. The 18 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 27 mg extended-release tablet also contains iron oxide black and iron oxide yellow. The 54 mg extended-release tablet also contains iron oxide red. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>43063-570-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-21) </PackageDescription>
<NDC11Code>43063-0570-21</NDC11Code>
<ProductNDC>43063-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20280229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>43063-570-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-28) </PackageDescription>
<NDC11Code>43063-0570-28</NDC11Code>
<ProductNDC>43063-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160127</StartMarketingDatePackage>
<EndMarketingDatePackage>20280229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>43063-570-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-30) </PackageDescription>
<NDC11Code>43063-0570-30</NDC11Code>
<ProductNDC>43063-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<EndMarketingDatePackage>20280229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>43063-570-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (43063-570-90) </PackageDescription>
<NDC11Code>43063-0570-90</NDC11Code>
<ProductNDC>43063-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<EndMarketingDatePackage>20280229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>43386-570-01</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (43386-570-01) </PackageDescription>
<NDC11Code>43386-0570-01</NDC11Code>
<ProductNDC>43386-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204115</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</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>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>53097-570-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (53097-570-60) > 60 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>53097-0570-60</NDC11Code>
<ProductNDC>53097-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marinol</ProprietaryName>
<NonProprietaryName>Dronabinol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018651</ApplicationNumber>
<LabelerName>ThePharmaNetwork, LLC</LabelerName>
<SubstanceName>DRONABINOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cannabinoid [EPC], Cannabinoids [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARINOL is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.</IndicationAndUsage>
<Description>Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas. C21H30O2 (molecular weight = 314.46) Dronabinol, the active ingredient in MARINOL (dronabinol capsules, USP), is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Each MARINOL capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54838-570-59</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE, PLASTIC (54838-570-59) </PackageDescription>
<NDC11Code>54838-0570-59</NDC11Code>
<ProductNDC>54838-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204171</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole Oral Solution is indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)], 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)], 3 Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)], 4 Treatment of Tourette’s Disorder [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Oral Solution. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include butylated hydroxyanisole, methylparaben, phosphoric acid, propylene glycol, propylparaben, sodium hydroxide, sucralose, and purified water. The oral solution is orange flavored.</Description>
</NDC>
<NDC>
<NDCCode>54838-570-70</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (54838-570-70) </PackageDescription>
<NDC11Code>54838-0570-70</NDC11Code>
<ProductNDC>54838-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204171</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole Oral Solution is indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)], 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)], 3 Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)], 4 Treatment of Tourette’s Disorder [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Oral Solution. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include butylated hydroxyanisole, methylparaben, phosphoric acid, propylene glycol, propylparaben, sodium hydroxide, sucralose, and purified water. The oral solution is orange flavored.</Description>
</NDC>
<NDC>
<NDCCode>58468-0050-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (58468-0050-1) / 5.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>58468-0050-01</NDC11Code>
<ProductNDC>58468-0050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xenpozyme</ProprietaryName>
<NonProprietaryName>Olipudase Alfa-rpcp</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761261</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>OLIPUDASE ALFA</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5.1mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.</IndicationAndUsage>
<Description>Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution.</Description>
</NDC>
<NDC>
<NDCCode>58468-0051-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>58468-0051-01</NDC11Code>
<ProductNDC>58468-0051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xenpozyme</ProprietaryName>
<NonProprietaryName>Olipudase Alfa-rpcp</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761261</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>OLIPUDASE ALFA</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1.1mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.</IndicationAndUsage>
<Description>Olipudase alfa-rpcp is a hydrolytic lysosomal sphingomyelin-specific enzyme consisting of 570 amino acids produced in a Chinese hamster ovary cell line by recombinant DNA technology. The molecular weight of olipudase alfa-rpcp is approximately 76 kDa. XENPOZYME (olipudase alfa-rpcp) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder for reconstitution and dilution to be administered via intravenous infusion. XENPOZYME is supplied in single-dose vials. Each 4 mg vial contains 4 mg olipudase alfa-rpcp, dibasic sodium phosphate (0.89 mg), methionine (14.92 mg), monobasic sodium phosphate (1.63 mg), and sucrose (50 mg). After reconstitution with 1.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. Each 20 mg vial contains 20 mg olipudase alfa-rpcp, dibasic sodium phosphate (4.47 mg), methionine (74.6 mg), monobasic sodium phosphate (8.17 mg), and sucrose (250 mg). After reconstitution with 5.1 mL of Sterile Water for Injection, USP, the final concentration is 4 mg/mL [see Dosage and Administration (2.6)]. The pH is 6.5 after reconstitution.</Description>
</NDC>
</NDCList>