{
"NDC": [
{
"NDCCode": "63402-208-28",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-208-28) / 7 TABLET in 1 BLISTER PACK (63402-208-07) ",
"NDC11Code": "63402-0208-28",
"ProductNDC": "63402-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "63402-208-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63402-208-30) ",
"NDC11Code": "63402-0208-30",
"ProductNDC": "63402-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "63402-208-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63402-208-90) ",
"NDC11Code": "63402-0208-90",
"ProductNDC": "63402-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sunovion Pharmaceuticals Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N"
},
{
"NDCCode": "63402-248-56",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-248-56) / 1 KIT in 1 BLISTER PACK (63402-248-14) * 7 TABLET in 1 BLISTER PACK (63402-204-17) * 7 TABLET in 1 BLISTER PACK (63402-208-17) ",
"NDC11Code": "63402-0248-56",
"ProductNDC": "63402-248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "63402-202-28",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-202-28) / 7 TABLET in 1 BLISTER PACK (63402-202-07) ",
"NDC11Code": "63402-0202-28",
"ProductNDC": "63402-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170913",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "63402-204-28",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-204-28) / 7 TABLET in 1 BLISTER PACK (63402-204-07) ",
"NDC11Code": "63402-0204-28",
"ProductNDC": "63402-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "63402-206-28",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-206-28) / 7 TABLET in 1 BLISTER PACK (63402-206-07) ",
"NDC11Code": "63402-0206-28",
"ProductNDC": "63402-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "59088-208-03",
"PackageDescription": "28 g in 1 TUBE (59088-208-03) ",
"NDC11Code": "59088-0208-03",
"ProductNDC": "59088-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxym Cream",
"NonProprietaryName": "Hydrocortisone 2%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240321",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240321",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.",
"Description": "Each gram of Hydroxym Cream contains 20 mg of hydrocortisone in a cream base of Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Avena Sativa (Oat) Kernel Extract, Bisabolol, Butyrospermum Parkii (Shea) Butter, Calcium Pantothenate (Vitamin B5), Carthamus Tiinctorius (Safflower) Oleosomes, Cetyl Alcohol, Citric Acid, Dimethicone, DL-alpha-Tocopheryl Acetate (Vitamin E), Glycerin, Glyceryl Stearate, Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Retinyl Palmitate, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearyl Alcohol, Tetrasodium EDTA, Zingiber Officinale (Ginger) Root Extract. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-] with the molecular formula (C 21H 30O 5) and is represented by the following structural formula:. Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "67046-208-28",
"PackageDescription": "28 CAPSULE in 1 BLISTER PACK (67046-208-28)",
"NDC11Code": "67046-0208-28",
"ProductNDC": "67046-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072575",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide."
},
{
"NDCCode": "69020-208-28",
"PackageDescription": "28 g in 1 TUBE (69020-208-28)",
"NDC11Code": "69020-0208-28",
"ProductNDC": "69020-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Makesense",
"NonProprietaryName": "Miconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140715",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Cherry Hill Sales Co",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "■ Cures most athlete's foot, jock itch, and ringworm. ■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions."
},
{
"NDCCode": "13733-208-01",
"PackageDescription": "20 g in 1 TUBE (13733-208-01)",
"NDC11Code": "13733-0208-01",
"ProductNDC": "13733-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha Closing Cover Concealer Spf30 No23",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Able C&C Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "20.24; 1.44",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "21130-208-03",
"PackageDescription": "3 CAN in 1 CARTON (21130-208-03) / 60 g in 1 CAN",
"NDC11Code": "21130-0208-03",
"ProductNDC": "21130-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil 5% (for Men)",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218616",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260703",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)."
},
{
"NDCCode": "31720-208-08",
"PackageDescription": "1 TUBE in 1 CARTON (31720-208-08) > 30 mL in 1 TUBE",
"NDC11Code": "31720-0208-08",
"ProductNDC": "31720-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sephora Skin Perfect Cc Sunscreen Broad Spectrum Spf 20 Medium-tan",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130117",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "S+",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "51; 28",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "42023-208-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-208-01) / 20 mL in 1 VIAL",
"NDC11Code": "42023-0208-01",
"ProductNDC": "42023-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Treprostinil",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20190925",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209382",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190925",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Treprostinil is a prostacyclin vasodilator indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).",
"Description": "Treprostinil Injection is a sterile solution of treprostinil formulated for subcutaneous or intravenous administration. Treprostinil Injection is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg /mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is."
},
{
"NDCCode": "43742-2035-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-2035-1) ",
"NDC11Code": "43742-2035-01",
"ProductNDC": "43742-2035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Virimmune",
"NonProprietaryName": "Allium Sativum, Echinacea (angustifolia), Ginkgo Biloba, Viscum Album, Hamamelis Virginiana, Aconitum Napellus, Allium Cepa, Arsenicum Album, Baptisia Tinctoria, Chelidonium Majus, Gelsemium Sempervirens, Mercurius Vivus, Natrum Muriaticum, Nux Vomica, Selenium Metallicum, Influenzinum (2020-2021), Morbillinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210722",
"EndMarketingDate": "20260928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "GARLIC; ECHINACEA ANGUSTIFOLIA WHOLE; GINKGO; VISCUM ALBUM FRUITING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACONITUM NAPELLUS WHOLE; ONION; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHELIDONIUM MAJUS WHOLE; GELSEMIUM SEMPERVIRENS ROOT; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); MEASLES VIRUS",
"StrengthNumber": "3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210722",
"EndMarketingDatePackage": "20260928",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of the symptoms of viral infections such as congestion, coughing, fever, fatigue, ongoing muscle or joint pain, lesions, lack of appetite, and GI discomfort.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "43857-0596-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (43857-0596-1) ",
"NDC11Code": "43857-0596-01",
"ProductNDC": "43857-0596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurotox",
"NonProprietaryName": "Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210520",
"EndMarketingDate": "20260426",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INDIUM; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IRON; LANTHANUM; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TOXICODENDRON PUBESCENS LEAF; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 15; 12; 12; 12; 12; 12; 30; 12; 12; 30; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 30; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210520",
"EndMarketingDatePackage": "20260426",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of symptoms due to numbness, tingling, muscle cramps, and nerve pain."
},
{
"NDCCode": "43857-0615-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (43857-0615-1) ",
"NDC11Code": "43857-0615-01",
"ProductNDC": "43857-0615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neurotox",
"NonProprietaryName": "Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210722",
"EndMarketingDate": "20260426",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BOTULINUM TOXIN TYPE A; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INDIUM; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IRON; LANTHANUM; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TOXICODENDRON PUBESCENS LEAF; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 15; 12; 12; 12; 12; 12; 30; 12; 12; 30; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 30; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210722",
"EndMarketingDatePackage": "20260426",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of symptoms due to numbness, tingling, muscle cramps, and nerve pain."
},
{
"NDCCode": "57297-208-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (57297-208-02) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "57297-0208-02",
"ProductNDC": "57297-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suprax",
"NonProprietaryName": "Cefixime",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203195",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "CEFIXIME",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "57297-208-08",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (57297-208-08)",
"NDC11Code": "57297-0208-08",
"ProductNDC": "57297-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suprax",
"NonProprietaryName": "Cefixime",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203195",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "CEFIXIME",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "57297-208-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (57297-208-11) > 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "57297-0208-11",
"ProductNDC": "57297-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suprax",
"NonProprietaryName": "Cefixime",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203195",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "CEFIXIME",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "57844-208-52",
"PackageDescription": "250 CAPSULE in 1 BOTTLE (57844-208-52) ",
"NDC11Code": "57844-0208-52",
"ProductNDC": "57844-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galzin",
"NonProprietaryName": "Zinc Acetate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970303",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020458",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ZINC ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970303",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent (See PRECAUTIONS: Monitoring Patients).",
"Description": "Zinc acetate as the dihydrate is a salt of zinc used to inhibit the absorption of copper in patients with Wilson's disease. Its structural formula is. C4H6O4Zn2H2O M.W. 219.51. Zinc acetate occurs as white crystals or granules, freely soluble in water and in boiling alcohol, and slightly soluble in alcohol. GALZIN® (Zinc Acetate) Capsules contain the equivalent of 25 or 50 mg of zinc, in addition to corn starch and magnesium stearate in gelatin capsules. The 25 mg capsule shells contain titanium dioxide and the 50 mg capsule shells contain titanium dioxide, methylparaben and propylparaben. The 25 mg capsule shells contain FD&C Blue #1; the 50 mg capsule shells contain FD&C Red #40, D&C Red #28, and D&C Yellow #10."
},
{
"NDCCode": "59368-208-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (59368-208-01) / 120 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "59368-0208-01",
"ProductNDC": "59368-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heb Nasal Allergy",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20170330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078104",
"LabelerName": "Sixarp, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "55",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170330",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose."
},
{
"NDCCode": "65121-208-20",
"PackageDescription": "208 g in 1 JAR (65121-208-20) ",
"NDC11Code": "65121-0208-20",
"ProductNDC": "65121-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senophile Dermal",
"NonProprietaryName": "Petrolatum, Cod Liver",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141224",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Pure Source, LLC",
"SubstanceName": "COD LIVER OIL; PETROLATUM",
"StrengthNumber": "10; 40",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170210",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects minor cuts, scrapes, burns. Temporarily protects chapped or cracked skin. Helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "67046-208-07",
"PackageDescription": "7 CAPSULE in 1 BLISTER PACK (67046-208-07)",
"NDC11Code": "67046-0208-07",
"ProductNDC": "67046-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072575",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
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<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>63402-208-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63402-208-30) </PackageDescription>
<NDC11Code>63402-0208-30</NDC11Code>
<ProductNDC>63402-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>63402-208-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63402-208-90) </PackageDescription>
<NDC11Code>63402-0208-90</NDC11Code>
<ProductNDC>63402-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sunovion Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63402-248-56</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (63402-248-56) / 1 KIT in 1 BLISTER PACK (63402-248-14) * 7 TABLET in 1 BLISTER PACK (63402-204-17) * 7 TABLET in 1 BLISTER PACK (63402-208-17) </PackageDescription>
<NDC11Code>63402-0248-56</NDC11Code>
<ProductNDC>63402-248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>63402-202-28</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (63402-202-28) / 7 TABLET in 1 BLISTER PACK (63402-202-07) </PackageDescription>
<NDC11Code>63402-0202-28</NDC11Code>
<ProductNDC>63402-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>63402-204-28</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (63402-204-28) / 7 TABLET in 1 BLISTER PACK (63402-204-07) </PackageDescription>
<NDC11Code>63402-0204-28</NDC11Code>
<ProductNDC>63402-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>63402-206-28</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (63402-206-28) / 7 TABLET in 1 BLISTER PACK (63402-206-07) </PackageDescription>
<NDC11Code>63402-0206-28</NDC11Code>
<ProductNDC>63402-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>59088-208-03</NDCCode>
<PackageDescription>28 g in 1 TUBE (59088-208-03) </PackageDescription>
<NDC11Code>59088-0208-03</NDC11Code>
<ProductNDC>59088-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxym Cream</ProprietaryName>
<NonProprietaryName>Hydrocortisone 2%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240321</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.</IndicationAndUsage>
<Description>Each gram of Hydroxym Cream contains 20 mg of hydrocortisone in a cream base of Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Avena Sativa (Oat) Kernel Extract, Bisabolol, Butyrospermum Parkii (Shea) Butter, Calcium Pantothenate (Vitamin B5), Carthamus Tiinctorius (Safflower) Oleosomes, Cetyl Alcohol, Citric Acid, Dimethicone, DL-alpha-Tocopheryl Acetate (Vitamin E), Glycerin, Glyceryl Stearate, Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Retinyl Palmitate, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearyl Alcohol, Tetrasodium EDTA, Zingiber Officinale (Ginger) Root Extract. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-] with the molecular formula (C 21H 30O 5) and is represented by the following structural formula:. Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>67046-208-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BLISTER PACK (67046-208-28)</PackageDescription>
<NDC11Code>67046-0208-28</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69020-208-28</NDCCode>
<PackageDescription>28 g in 1 TUBE (69020-208-28)</PackageDescription>
<NDC11Code>69020-0208-28</NDC11Code>
<ProductNDC>69020-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Makesense</ProprietaryName>
<NonProprietaryName>Miconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Cherry Hill Sales Co</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>■ Cures most athlete's foot, jock itch, and ringworm. ■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13733-208-01</NDCCode>
<PackageDescription>20 g in 1 TUBE (13733-208-01)</PackageDescription>
<NDC11Code>13733-0208-01</NDC11Code>
<ProductNDC>13733-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha Closing Cover Concealer Spf30 No23</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Able C&C Co., Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>20.24; 1.44</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21130-208-03</NDCCode>
<PackageDescription>3 CAN in 1 CARTON (21130-208-03) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>21130-0208-03</NDC11Code>
<ProductNDC>21130-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil 5% (for Men)</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218616</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31720-208-08</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (31720-208-08) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>31720-0208-08</NDC11Code>
<ProductNDC>31720-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sephora Skin Perfect Cc Sunscreen Broad Spectrum Spf 20 Medium-tan</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>S+</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>51; 28</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>42023-208-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-208-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0208-01</NDC11Code>
<ProductNDC>42023-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Treprostinil</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190925</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209382</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190925</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treprostinil is a prostacyclin vasodilator indicated for: 1 Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). (1.1), 2 Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2).</IndicationAndUsage>
<Description>Treprostinil Injection is a sterile solution of treprostinil formulated for subcutaneous or intravenous administration. Treprostinil Injection is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg /mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2. Treprostinil is chemically stable at room temperature and neutral pH. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is.</Description>
</NDC>
<NDC>
<NDCCode>43742-2035-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-2035-1) </PackageDescription>
<NDC11Code>43742-2035-01</NDC11Code>
<ProductNDC>43742-2035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Virimmune</ProprietaryName>
<NonProprietaryName>Allium Sativum, Echinacea (angustifolia), Ginkgo Biloba, Viscum Album, Hamamelis Virginiana, Aconitum Napellus, Allium Cepa, Arsenicum Album, Baptisia Tinctoria, Chelidonium Majus, Gelsemium Sempervirens, Mercurius Vivus, Natrum Muriaticum, Nux Vomica, Selenium Metallicum, Influenzinum (2020-2021), Morbillinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210722</StartMarketingDate>
<EndMarketingDate>20260928</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>GARLIC; ECHINACEA ANGUSTIFOLIA WHOLE; GINKGO; VISCUM ALBUM FRUITING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACONITUM NAPELLUS WHOLE; ONION; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHELIDONIUM MAJUS WHOLE; GELSEMIUM SEMPERVIRENS ROOT; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); MEASLES VIRUS</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210722</StartMarketingDatePackage>
<EndMarketingDatePackage>20260928</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of the symptoms of viral infections such as congestion, coughing, fever, fatigue, ongoing muscle or joint pain, lesions, lack of appetite, and GI discomfort.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43857-0596-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (43857-0596-1) </PackageDescription>
<NDC11Code>43857-0596-01</NDC11Code>
<ProductNDC>43857-0596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurotox</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210520</StartMarketingDate>
<EndMarketingDate>20260426</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INDIUM; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IRON; LANTHANUM; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TOXICODENDRON PUBESCENS LEAF; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 15; 12; 12; 12; 12; 12; 30; 12; 12; 30; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 30; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210520</StartMarketingDatePackage>
<EndMarketingDatePackage>20260426</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of symptoms due to numbness, tingling, muscle cramps, and nerve pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43857-0615-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (43857-0615-1) </PackageDescription>
<NDC11Code>43857-0615-01</NDC11Code>
<ProductNDC>43857-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neurotox</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210722</StartMarketingDate>
<EndMarketingDate>20260426</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BOTULINUM TOXIN TYPE A; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INDIUM; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IRON; LANTHANUM; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TOXICODENDRON PUBESCENS LEAF; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 15; 12; 12; 12; 12; 12; 30; 12; 12; 30; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 30; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210722</StartMarketingDatePackage>
<EndMarketingDatePackage>20260426</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of symptoms due to numbness, tingling, muscle cramps, and nerve pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57297-208-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (57297-208-02) > 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57297-0208-02</NDC11Code>
<ProductNDC>57297-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suprax</ProprietaryName>
<NonProprietaryName>Cefixime</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203195</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>CEFIXIME</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57297-208-08</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (57297-208-08)</PackageDescription>
<NDC11Code>57297-0208-08</NDC11Code>
<ProductNDC>57297-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suprax</ProprietaryName>
<NonProprietaryName>Cefixime</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203195</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>CEFIXIME</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57297-208-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (57297-208-11) > 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57297-0208-11</NDC11Code>
<ProductNDC>57297-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suprax</ProprietaryName>
<NonProprietaryName>Cefixime</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203195</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>CEFIXIME</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57844-208-52</NDCCode>
<PackageDescription>250 CAPSULE in 1 BOTTLE (57844-208-52) </PackageDescription>
<NDC11Code>57844-0208-52</NDC11Code>
<ProductNDC>57844-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galzin</ProprietaryName>
<NonProprietaryName>Zinc Acetate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970303</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020458</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ZINC ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970303</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent (See PRECAUTIONS: Monitoring Patients).</IndicationAndUsage>
<Description>Zinc acetate as the dihydrate is a salt of zinc used to inhibit the absorption of copper in patients with Wilson's disease. Its structural formula is. C4H6O4Zn2H2O M.W. 219.51. Zinc acetate occurs as white crystals or granules, freely soluble in water and in boiling alcohol, and slightly soluble in alcohol. GALZIN® (Zinc Acetate) Capsules contain the equivalent of 25 or 50 mg of zinc, in addition to corn starch and magnesium stearate in gelatin capsules. The 25 mg capsule shells contain titanium dioxide and the 50 mg capsule shells contain titanium dioxide, methylparaben and propylparaben. The 25 mg capsule shells contain FD&C Blue #1; the 50 mg capsule shells contain FD&C Red #40, D&C Red #28, and D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>59368-208-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59368-208-01) / 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>59368-0208-01</NDC11Code>
<ProductNDC>59368-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heb Nasal Allergy</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078104</ApplicationNumber>
<LabelerName>Sixarp, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>55</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65121-208-20</NDCCode>
<PackageDescription>208 g in 1 JAR (65121-208-20) </PackageDescription>
<NDC11Code>65121-0208-20</NDC11Code>
<ProductNDC>65121-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senophile Dermal</ProprietaryName>
<NonProprietaryName>Petrolatum, Cod Liver</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141224</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Pure Source, LLC</LabelerName>
<SubstanceName>COD LIVER OIL; PETROLATUM</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects minor cuts, scrapes, burns. Temporarily protects chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67046-208-07</NDCCode>
<PackageDescription>7 CAPSULE in 1 BLISTER PACK (67046-208-07)</PackageDescription>
<NDC11Code>67046-0208-07</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-208-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BLISTER PACK (67046-208-14)</PackageDescription>
<NDC11Code>67046-0208-14</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-208-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BLISTER PACK (67046-208-15)</PackageDescription>
<NDC11Code>67046-0208-15</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-208-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BLISTER PACK (67046-208-20)</PackageDescription>
<NDC11Code>67046-0208-20</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-208-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BLISTER PACK (67046-208-21)</PackageDescription>
<NDC11Code>67046-0208-21</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-208-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (67046-208-30)</PackageDescription>
<NDC11Code>67046-0208-30</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-208-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BLISTER PACK (67046-208-60)</PackageDescription>
<NDC11Code>67046-0208-60</NDC11Code>
<ProductNDC>67046-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride capsules, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula is C 19H 21N 5O 4 HCl. It is a white to tan powder, slightly soluble in water and methanol, very slightly soluble in alcohol, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The empty gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The imprinting ink also contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
</NDCList>