{
"NDC": [
{
"NDCCode": "11410-215-90",
"PackageDescription": "1 KIT in 1 BOX (11410-215-90) * 60 mL in 1 BOTTLE * 60 mL in 1 BOTTLE, PLASTIC (11410-040-15) * 60 mL in 1 BOTTLE (11410-005-20) ",
"NDC11Code": "11410-0215-90",
"ProductNDC": "11410-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Solution Kit",
"NonProprietaryName": "Solutions Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Alchemee, LLC",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N"
},
{
"NDCCode": "11410-215-30",
"PackageDescription": "1 KIT in 1 BOX (11410-215-30) * 60 mL in 1 BOTTLE * 60 mL in 1 BOTTLE, PLASTIC (11410-040-15) * 60 mL in 1 BOTTLE (11410-005-20) ",
"NDC11Code": "11410-0215-30",
"ProductNDC": "11410-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Solution Kit",
"NonProprietaryName": "Solutions Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Alchemee, LLC",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N"
},
{
"NDCCode": "11410-215-60",
"PackageDescription": "1 KIT in 1 BOX (11410-215-60) * 60 mL in 1 BOTTLE * 60 mL in 1 BOTTLE, PLASTIC (11410-040-15) * 60 mL in 1 BOTTLE (11410-005-20) ",
"NDC11Code": "11410-0215-60",
"ProductNDC": "11410-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Solution Kit",
"NonProprietaryName": "Solutions Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Alchemee, LLC",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N"
},
{
"NDCCode": "11410-044-32",
"PackageDescription": "90 mL in 1 BOTTLE, PLASTIC (11410-044-32)",
"NDC11Code": "11410-0044-32",
"ProductNDC": "11410-044",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Repairing Treatment",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090330",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11410-044-35",
"PackageDescription": "90 mL in 1 BOTTLE, PLASTIC (11410-044-35)",
"NDC11Code": "11410-0044-35",
"ProductNDC": "11410-044",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Repairing Treatment",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090330",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11410-047-90",
"PackageDescription": "1 TUBE in 1 BOX (11410-047-90) / 89 mL in 1 TUBE",
"NDC11Code": "11410-0047-90",
"ProductNDC": "11410-047",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactivplus Pore Clearing Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Alchemee, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "for the management of acne."
},
{
"NDCCode": "11410-049-74",
"PackageDescription": "1 TUBE in 1 BOX (11410-049-74) > 90 mL in 1 TUBE",
"NDC11Code": "11410-0049-74",
"ProductNDC": "11410-049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Skin Clearing Water",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161028",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "The Proactiv Company, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161028",
"SamplePackage": "N"
},
{
"NDCCode": "11410-201-91",
"PackageDescription": "10 PACKET in 1 BOX (11410-201-91) > 1 CLOTH in 1 PACKET (11410-201-90)",
"NDC11Code": "11410-0201-91",
"ProductNDC": "11410-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Clear Zone Body Pads",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".036",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11410-207-35",
"PackageDescription": "90 mL in 1 BOTTLE, PLASTIC (11410-207-35)",
"NDC11Code": "11410-0207-35",
"ProductNDC": "11410-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Repairing",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071025",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11410-920-32",
"PackageDescription": "90 mL in 1 BOTTLE, PLASTIC (11410-920-32)",
"NDC11Code": "11410-0920-32",
"ProductNDC": "11410-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Repairing Treatment",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11410-920-35",
"PackageDescription": "90 mL in 1 BOTTLE, PLASTIC (11410-920-35)",
"NDC11Code": "11410-0920-35",
"ProductNDC": "11410-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Repairing Treatment",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11410-920-52",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (11410-920-52) > 90 mL in 1 BOTTLE, PLASTIC (11410-920-32)",
"NDC11Code": "11410-0920-52",
"ProductNDC": "11410-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Repairing Treatment",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10544-215-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10544-215-90)",
"NDC11Code": "10544-0215-90",
"ProductNDC": "10544-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "12714-215-90",
"PackageDescription": "90 mg in 1 BAG (12714-215-90) ",
"NDC11Code": "12714-0215-90",
"ProductNDC": "12714-215",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Risankizumbab",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20190423",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
"SubstanceName": "RISANKIZUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/90mg",
"Status": "Unfinished",
"LastUpdate": "2024-06-20",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "23-APR-19"
},
{
"NDCCode": "16729-215-15",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16729-215-15) ",
"NDC11Code": "16729-0215-15",
"ProductNDC": "16729-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202825",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180723",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate anhydrous, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue # 2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, iron oxide yellow (in 100 mg tablet), and titanium dioxide."
},
{
"NDCCode": "24236-215-19",
"PackageDescription": "90 TABLET in 1 BOTTLE (24236-215-19)",
"NDC11Code": "24236-0215-19",
"ProductNDC": "24236-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040489",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "29300-215-19",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-215-19) ",
"NDC11Code": "29300-0215-19",
"ProductNDC": "29300-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan And Hydrochlorothiazide",
"NonProprietaryName": "Irbesartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207018",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "IRBESARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "150; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180331",
"SamplePackage": "N",
"IndicationAndUsage": "Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: 1 In patients not adequately controlled with monotherapy. (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1).",
"Description": "Irbesartan and hydrochlorothiazide tablets, USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan, USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl) benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan, USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: mannitol, croscarmellose sodium, poloxamer 188, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, lecithin, ferric oxide red and ferric oxide yellow."
},
{
"NDCCode": "43063-215-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43063-215-90)",
"NDC11Code": "43063-0215-90",
"ProductNDC": "43063-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202297",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43353-215-60",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-215-60)",
"NDC11Code": "43353-0215-60",
"ProductNDC": "43353-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076368",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.",
"Description": "The Potassium Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose."
},
{
"NDCCode": "46708-215-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (46708-215-90) ",
"NDC11Code": "46708-0215-90",
"ProductNDC": "46708-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Olmesartran Medoxomil",
"NonProprietaryName": "Amlodipine Besylate And Olmesartran Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207073",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170718",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. 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. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.",
"Description": "Amlodipine and olmesartan medoxomil tablets provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablet is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl- 3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet is chemically described as 2,3dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Amlodipine and olmesartan medoxomil tablet contains amlodipine besylate, a white or almost white powder, and olmesartan medoxomil, white to off-white, crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is freely soluble in methanol, sparingly soluble in alcohol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil is sparingly soluble in methanol, practically insoluble in water. Each amlodipine and olmesartan medoxomil tablet also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate and colloidal silicon dioxide. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (5/40 mg, 10/20 mg and 10/40 mg tablets), and iron oxide black (5/40 mg, 10/20 mg and 10/40 mg tablets)."
},
{
"NDCCode": "49999-215-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (49999-215-90)",
"NDC11Code": "49999-0215-90",
"ProductNDC": "49999-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074132",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "53217-215-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (53217-215-90)",
"NDC11Code": "53217-0215-90",
"ProductNDC": "53217-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078895",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "55648-215-03",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (55648-215-03)",
"NDC11Code": "55648-0215-03",
"ProductNDC": "55648-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium And Misoprostol",
"NonProprietaryName": "Diclofenac Sodium And Misoprostol",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201948",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "50; .2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57297-215-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (57297-215-09)",
"NDC11Code": "57297-0215-09",
"ProductNDC": "57297-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078245",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
"StrengthNumber": "12.5; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION).",
"Description": "Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white amorphous powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg and 100 mg/25 mg also contain iron oxide yellow. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium."
},
{
"NDCCode": "58809-215-90",
"PackageDescription": "90 min in 1 BOTTLE (58809-215-90) ",
"NDC11Code": "58809-0215-90",
"ProductNDC": "58809-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Texas Allergy Relief Plus Cedar Fever",
"NonProprietaryName": "Antigens All Zones Grasses, Trees, And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "SOLIDAGO CANADENSIS POLLEN; PHYTOLACCA AMERICANA ROOT; AMBROSIA ARTEMISIIFOLIA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; PINUS ECHINATA POLLEN; SORGHUM HALEPENSE POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; OLEA EUROPAEA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; ARTEMISIA VULGARIS POLLEN; POPULUS NIGRA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; QUERCUS RUBRA POLLEN; SECALE CEREALE POLLEN; CARYA OVATA POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS TUBERCULATUS POLLEN; RUMEX CRISPUS POLLEN; CELTIS OCCIDENTALIS POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; AMBROSIA ACANTHICARPA POLLEN; CHENOPODIUM ALBUM POLLEN; BAPTISIA TINCTORIA ROOT; TAXODIUM DISTICHUM POLLEN; JUGLANS NIGRA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; MYRRH; ULMUS AMERICANA POLLEN; GOLDENSEAL; EUPATORIUM CAPILLIFOLIUM POLLEN; PROSOPIS JULIFLORA POLLEN; MORUS ALBA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; FRAXINUS AMERICANA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; URTICA DIOICA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS STROBUS POLLEN; AMBROSIA BIDENTATA POLLEN; ARTEMISIA TRIDENTATA POLLEN; XANTHIUM STRUMARIUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; BETULA NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRICA CERIFERA POLLEN; SCHINUS MOLLE POLLEN; BASSIA SCOPARIA POLLEN; POA PRATENSIS POLLEN; QUERCUS VIRGINIANA POLLEN; JUNIPERUS ASHEI POLLEN; MELALEUCA QUINQUENERVIA POLLEN; QUERCUS GAMBELII POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; LIGUSTRUM VULGARE POLLEN; AMBROSIA TRIFIDA POLLEN; MORUS RUBRA POLLEN; SALSOLA KALI POLLEN; ATRIPLEX WRIGHTII POLLEN; DISTICHLIS SPICATA POLLEN; AMARANTHUS SPINOSUS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; HOLCUS LANATUS POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; URTICA URENS WHOLE; HESPEROCYPARIS ARIZONICA POLLEN; PASPALUM NOTATUM POLLEN; FAGUS GRANDIFOLIA POLLEN; ACER NEGUNDO POLLEN; AMARANTHUS PALMERI POLLEN; AVENA SATIVA POLLEN; ACACIA DEALBATA POLLEN; FRAXINUS VELUTINA POLLEN; ZEA MAYS POLLEN; TRITICUM AESTIVUM POLLEN; NASTURTIUM OFFICINALE",
"StrengthNumber": "6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 5; 5; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231110",
"SamplePackage": "N",
"IndicationAndUsage": "This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
"NDCCode": "62332-215-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62332-215-90) ",
"NDC11Code": "62332-0215-90",
"ProductNDC": "62332-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Olmesartran Medoxomil",
"NonProprietaryName": "Amlodipine Besylate And Olmesartran Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207073",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170718",
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"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. 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. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.",
"Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablet, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl- 3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablet, USP is chemically described as 2,3dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate, USP is. The structural formula for olmesartan medoxomil, USP is. Amlodipine and olmesartan medoxomil tablets, USP contains amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP white to off-white, crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively. Amlodipine besylate, USP is freely soluble in methanol, sparingly soluble in alcohol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is sparingly soluble in methanol, practically insoluble in water. Each amlodipine and olmesartan medoxomil tablets, USP also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate and colloidal silicon dioxide. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (5/40 mg, 10/20 mg and 10/40 mg tablets), and iron oxide black (5/40 mg, 10/20 mg and 10/40 mg tablets)."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090011",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "AMLODIPINE; VALSARTAN",
"StrengthNumber": "10; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
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"IndicationAndUsage": "Amlodipine and valsartan is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).",
"Description": "Amlodipine and valsartan,USP is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2‑ chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
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"ProprietaryName": "Diclofenac Sodium And Misoprostol",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"ApplicationNumber": "ANDA078245",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
"StrengthNumber": "12.5; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
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"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablet is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white amorphous powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/ 12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/ 25 mg also contain iron oxide yellow. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/ 25 mg contains 8.48 mg (0.216 mEq) of potassium."
},
{
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"PackageDescription": "90 CAPSULE in 1 BOTTLE (68382-215-16) ",
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"ProductNDC": "68382-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079017",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
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"IndicationAndUsage": "Atomoxetine is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Each atomoxetine capsule intended for oral administration contains atomoxetine hydrochloride, USP equivalent to atomoxetine 10 mg or 18 mg or 25 mg or 40 mg or 60 mg or 80 mg or 100 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. Additionally each 18 mg capsule shell contains: iron oxide yellow, each 25 mg and 40 mg capsule shell contains: FD & C blue # 2, each 60 mg capsule shell contains: FD & C blue # 2 and iron oxide yellow and each 80 mg and 100 mg capsule shell contains: iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac."
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11410-207-35</NDCCode>
<PackageDescription>90 mL in 1 BOTTLE, PLASTIC (11410-207-35)</PackageDescription>
<NDC11Code>11410-0207-35</NDC11Code>
<ProductNDC>11410-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Repairing</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071025</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11410-920-32</NDCCode>
<PackageDescription>90 mL in 1 BOTTLE, PLASTIC (11410-920-32)</PackageDescription>
<NDC11Code>11410-0920-32</NDC11Code>
<ProductNDC>11410-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Repairing Treatment</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11410-920-35</NDCCode>
<PackageDescription>90 mL in 1 BOTTLE, PLASTIC (11410-920-35)</PackageDescription>
<NDC11Code>11410-0920-35</NDC11Code>
<ProductNDC>11410-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Repairing Treatment</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11410-920-52</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (11410-920-52) > 90 mL in 1 BOTTLE, PLASTIC (11410-920-32)</PackageDescription>
<NDC11Code>11410-0920-52</NDC11Code>
<ProductNDC>11410-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Repairing Treatment</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10544-215-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10544-215-90)</PackageDescription>
<NDC11Code>10544-0215-90</NDC11Code>
<ProductNDC>10544-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>12714-215-90</NDCCode>
<PackageDescription>90 mg in 1 BAG (12714-215-90) </PackageDescription>
<NDC11Code>12714-0215-90</NDC11Code>
<ProductNDC>12714-215</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Risankizumbab</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20190423</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
<SubstanceName>RISANKIZUMAB</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/90mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-06-20</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-APR-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16729-215-15</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16729-215-15) </PackageDescription>
<NDC11Code>16729-0215-15</NDC11Code>
<ProductNDC>16729-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202825</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate anhydrous, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue # 2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, iron oxide yellow (in 100 mg tablet), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24236-215-19</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (24236-215-19)</PackageDescription>
<NDC11Code>24236-0215-19</NDC11Code>
<ProductNDC>24236-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>29300-215-19</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-215-19) </PackageDescription>
<NDC11Code>29300-0215-19</NDC11Code>
<ProductNDC>29300-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Irbesartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207018</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>IRBESARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>150; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: 1 In patients not adequately controlled with monotherapy. (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1).</IndicationAndUsage>
<Description>Irbesartan and hydrochlorothiazide tablets, USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan, USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl) benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan, USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: mannitol, croscarmellose sodium, poloxamer 188, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, lecithin, ferric oxide red and ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>43063-215-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43063-215-90)</PackageDescription>
<NDC11Code>43063-0215-90</NDC11Code>
<ProductNDC>43063-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202297</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43353-215-60</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-215-60)</PackageDescription>
<NDC11Code>43353-0215-60</NDC11Code>
<ProductNDC>43353-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076368</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.</IndicationAndUsage>
<Description>The Potassium Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>46708-215-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (46708-215-90) </PackageDescription>
<NDC11Code>46708-0215-90</NDC11Code>
<ProductNDC>46708-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Olmesartran Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Olmesartran Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207073</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. 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. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil tablets provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablet is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl- 3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet is chemically described as 2,3dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate is. The structural formula for olmesartan medoxomil is. Amlodipine and olmesartan medoxomil tablet contains amlodipine besylate, a white or almost white powder, and olmesartan medoxomil, white to off-white, crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is freely soluble in methanol, sparingly soluble in alcohol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil is sparingly soluble in methanol, practically insoluble in water. Each amlodipine and olmesartan medoxomil tablet also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate and colloidal silicon dioxide. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (5/40 mg, 10/20 mg and 10/40 mg tablets), and iron oxide black (5/40 mg, 10/20 mg and 10/40 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>49999-215-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (49999-215-90)</PackageDescription>
<NDC11Code>49999-0215-90</NDC11Code>
<ProductNDC>49999-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074132</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53217-215-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (53217-215-90)</PackageDescription>
<NDC11Code>53217-0215-90</NDC11Code>
<ProductNDC>53217-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078895</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>55648-215-03</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (55648-215-03)</PackageDescription>
<NDC11Code>55648-0215-03</NDC11Code>
<ProductNDC>55648-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201948</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; .2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57297-215-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (57297-215-09)</PackageDescription>
<NDC11Code>57297-0215-09</NDC11Code>
<ProductNDC>57297-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078245</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>12.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white amorphous powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg and 100 mg/25 mg also contain iron oxide yellow. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.</Description>
</NDC>
<NDC>
<NDCCode>58809-215-90</NDCCode>
<PackageDescription>90 min in 1 BOTTLE (58809-215-90) </PackageDescription>
<NDC11Code>58809-0215-90</NDC11Code>
<ProductNDC>58809-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Texas Allergy Relief Plus Cedar Fever</ProprietaryName>
<NonProprietaryName>Antigens All Zones Grasses, Trees, And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>SOLIDAGO CANADENSIS POLLEN; PHYTOLACCA AMERICANA ROOT; AMBROSIA ARTEMISIIFOLIA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; PINUS ECHINATA POLLEN; SORGHUM HALEPENSE POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; OLEA EUROPAEA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; ARTEMISIA VULGARIS POLLEN; POPULUS NIGRA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; QUERCUS RUBRA POLLEN; SECALE CEREALE POLLEN; CARYA OVATA POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS TUBERCULATUS POLLEN; RUMEX CRISPUS POLLEN; CELTIS OCCIDENTALIS POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; AMBROSIA ACANTHICARPA POLLEN; CHENOPODIUM ALBUM POLLEN; BAPTISIA TINCTORIA ROOT; TAXODIUM DISTICHUM POLLEN; JUGLANS NIGRA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; MYRRH; ULMUS AMERICANA POLLEN; GOLDENSEAL; EUPATORIUM CAPILLIFOLIUM POLLEN; PROSOPIS JULIFLORA POLLEN; MORUS ALBA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; FRAXINUS AMERICANA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; URTICA DIOICA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS STROBUS POLLEN; AMBROSIA BIDENTATA POLLEN; ARTEMISIA TRIDENTATA POLLEN; XANTHIUM STRUMARIUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; BETULA NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRICA CERIFERA POLLEN; SCHINUS MOLLE POLLEN; BASSIA SCOPARIA POLLEN; POA PRATENSIS POLLEN; QUERCUS VIRGINIANA POLLEN; JUNIPERUS ASHEI POLLEN; MELALEUCA QUINQUENERVIA POLLEN; QUERCUS GAMBELII POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; LIGUSTRUM VULGARE POLLEN; AMBROSIA TRIFIDA POLLEN; MORUS RUBRA POLLEN; SALSOLA KALI POLLEN; ATRIPLEX WRIGHTII POLLEN; DISTICHLIS SPICATA POLLEN; AMARANTHUS SPINOSUS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; HOLCUS LANATUS POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; URTICA URENS WHOLE; HESPEROCYPARIS ARIZONICA POLLEN; PASPALUM NOTATUM POLLEN; FAGUS GRANDIFOLIA POLLEN; ACER NEGUNDO POLLEN; AMARANTHUS PALMERI POLLEN; AVENA SATIVA POLLEN; ACACIA DEALBATA POLLEN; FRAXINUS VELUTINA POLLEN; ZEA MAYS POLLEN; TRITICUM AESTIVUM POLLEN; NASTURTIUM OFFICINALE</SubstanceName>
<StrengthNumber>6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 5; 5; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5</StrengthNumber>
<StrengthUnit>[hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min; [hp_X]/min</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62332-215-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62332-215-90) </PackageDescription>
<NDC11Code>62332-0215-90</NDC11Code>
<ProductNDC>62332-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Olmesartran Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Olmesartran Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207073</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. 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. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablet, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl- 3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablet, USP is chemically described as 2,3dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The structural formula for amlodipine besylate, USP is. The structural formula for olmesartan medoxomil, USP is. Amlodipine and olmesartan medoxomil tablets, USP contains amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP white to off-white, crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively. Amlodipine besylate, USP is freely soluble in methanol, sparingly soluble in alcohol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is sparingly soluble in methanol, practically insoluble in water. Each amlodipine and olmesartan medoxomil tablets, USP also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate and colloidal silicon dioxide. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (5/40 mg, 10/20 mg and 10/40 mg tablets), and iron oxide black (5/40 mg, 10/20 mg and 10/40 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>64380-215-02</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (64380-215-02) </PackageDescription>
<NDC11Code>64380-0215-02</NDC11Code>
<ProductNDC>64380-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090011</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>AMLODIPINE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and valsartan is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and valsartan,USP is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2‑ chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64679-215-03</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-215-03)</PackageDescription>
<NDC11Code>64679-0215-03</NDC11Code>
<ProductNDC>64679-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201948</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; .2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68180-215-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68180-215-09) </PackageDescription>
<NDC11Code>68180-0215-09</NDC11Code>
<ProductNDC>68180-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078245</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>12.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide tablet is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white amorphous powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/ 12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/ 25 mg also contain iron oxide yellow. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/ 25 mg contains 8.48 mg (0.216 mEq) of potassium.</Description>
</NDC>
<NDC>
<NDCCode>68382-215-16</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (68382-215-16) </PackageDescription>
<NDC11Code>68382-0215-16</NDC11Code>
<ProductNDC>68382-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079017</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Each atomoxetine capsule intended for oral administration contains atomoxetine hydrochloride, USP equivalent to atomoxetine 10 mg or 18 mg or 25 mg or 40 mg or 60 mg or 80 mg or 100 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. Additionally each 18 mg capsule shell contains: iron oxide yellow, each 25 mg and 40 mg capsule shell contains: FD & C blue # 2, each 60 mg capsule shell contains: FD & C blue # 2 and iron oxide yellow and each 80 mg and 100 mg capsule shell contains: iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
</NDCList>