{
"NDC": [
{
"NDCCode": "72162-2351-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (72162-2351-3) ",
"NDC11Code": "72162-2351-03",
"ProductNDC": "72162-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090533",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240814",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .",
"Description": "Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49."
},
{
"NDCCode": "15631-2351-3",
"PackageDescription": "100 TABLET in 1 CONTAINER (15631-2351-3)",
"NDC11Code": "15631-2351-03",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "36987-2351-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2351-3)",
"NDC11Code": "36987-2351-03",
"ProductNDC": "36987-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Para Grass Pollen",
"NonProprietaryName": "Para Grass Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "UROCHLOA MUTICA POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2351-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-2351-3) ",
"NDC11Code": "37662-2351-03",
"ProductNDC": "37662-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Piper Methysticum",
"NonProprietaryName": "Piper Methysticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230112",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "PIPER METHYSTICUM ROOT",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230112",
"SamplePackage": "N"
},
{
"NDCCode": "53002-2351-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-2351-3) ",
"NDC11Code": "53002-2351-03",
"ProductNDC": "53002-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203245",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)Chronic Stable AnginaVasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate Tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "54868-2351-3",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-2351-3)",
"NDC11Code": "54868-2351-03",
"ProductNDC": "54868-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotensin",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019851",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Lotensin is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40-mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (5-mg and 40-mg tablets), starch, talc, and titanium dioxide."
},
{
"NDCCode": "63629-2351-1",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (63629-2351-1) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "63629-2351-01",
"ProductNDC": "63629-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-lo- Estarylla",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091232",
"LabelerName": "Bryant Ranch Prepack",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230210",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.18 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide. , 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.6 sunset yellow fcf aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 4 Each green placebo tablet contains only inert ingredients, as follows: crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, lecithin (soya), magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide."
},
{
"NDCCode": "70518-2351-0",
"PackageDescription": "6 POUCH in 1 CARTON (70518-2351-0) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL",
"NDC11Code": "70518-2351-00",
"ProductNDC": "70518-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20191007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077559",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE",
"StrengthNumber": "2.5; .5",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191007",
"SamplePackage": "N"
},
{
"NDCCode": "71335-2351-3",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-3) ",
"NDC11Code": "71335-2351-03",
"ProductNDC": "71335-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240221",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "0378-2351-77",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-77) ",
"NDC11Code": "00378-2351-77",
"ProductNDC": "0378-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20150803",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078936",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151207",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "0378-2351-93",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-93) ",
"NDC11Code": "00378-2351-93",
"ProductNDC": "0378-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20150803",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078936",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150803",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "15631-2351-0",
"PackageDescription": "1 TABLET in 1 BLISTER PACK (15631-2351-0)",
"NDC11Code": "15631-2351-00",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2351-1",
"PackageDescription": "4 TABLET in 1 BLISTER PACK (15631-2351-1)",
"NDC11Code": "15631-2351-01",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2351-2",
"PackageDescription": "50 TABLET in 1 CONTAINER (15631-2351-2)",
"NDC11Code": "15631-2351-02",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2351-4",
"PackageDescription": "250 TABLET in 1 CONTAINER (15631-2351-4)",
"NDC11Code": "15631-2351-04",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2351-5",
"PackageDescription": "500 TABLET in 1 CONTAINER (15631-2351-5)",
"NDC11Code": "15631-2351-05",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2351-6",
"PackageDescription": "1000 TABLET in 1 CONTAINER (15631-2351-6)",
"NDC11Code": "15631-2351-06",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2351-7",
"PackageDescription": "10000 TABLET in 1 CONTAINER (15631-2351-7)",
"NDC11Code": "15631-2351-07",
"ProductNDC": "15631-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Five Phos",
"NonProprietaryName": "Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "53002-2351-0",
"PackageDescription": "100 TABLET in 1 BOTTLE (53002-2351-0) ",
"NDC11Code": "53002-2351-00",
"ProductNDC": "53002-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203245",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)Chronic Stable AnginaVasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate Tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "54868-2351-0",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (54868-2351-0)",
"NDC11Code": "54868-2351-00",
"ProductNDC": "54868-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotensin",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019851",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Lotensin is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40-mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (5-mg and 40-mg tablets), starch, talc, and titanium dioxide."
},
{
"NDCCode": "54868-2351-2",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (54868-2351-2)",
"NDC11Code": "54868-2351-02",
"ProductNDC": "54868-2351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotensin",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019851",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Lotensin is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40-mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (5-mg and 40-mg tablets), starch, talc, and titanium dioxide."
},
{
"NDCCode": "55714-2351-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-2351-0)",
"NDC11Code": "55714-2351-00",
"ProductNDC": "55714-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitiligo",
"NonProprietaryName": "Arsenicum Alb., Berber. Vulg., Bovista, Dolichos, Echinacea, Hura Brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus Toxicodendron, Rumex Crisp., Sepia, Taraxacum,thuja Occ., Urtica Ur., Iris Versicolor",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Vitiligo Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying."
},
{
"NDCCode": "55714-2351-1",
"PackageDescription": "28.35 g in 1 BOTTLE, GLASS (55714-2351-1)",
"NDC11Code": "55714-2351-01",
"ProductNDC": "55714-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitiligo",
"NonProprietaryName": "Arsenicum Alb., Berber. Vulg., Bovista, Dolichos, Echinacea, Hura Brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus Toxicodendron, Rumex Crisp., Sepia, Taraxacum,thuja Occ., Urtica Ur., Iris Versicolor",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Vitiligo Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying."
},
{
"NDCCode": "55714-2351-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-2351-2)",
"NDC11Code": "55714-2351-02",
"ProductNDC": "55714-2351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitiligo",
"NonProprietaryName": "Arsenicum Alb., Berber. Vulg., Bovista, Dolichos, Echinacea, Hura Brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus Toxicodendron, Rumex Crisp., Sepia, Taraxacum,thuja Occ., Urtica Ur., Iris Versicolor",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Vitiligo Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying."
},
{
"NDCCode": "72162-1054-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72162-1054-3) ",
"NDC11Code": "72162-1054-03",
"ProductNDC": "72162-1054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087479",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250512",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows:. C 21H 27CIN 2O 2C 23H 16O 6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze."
},
{
"NDCCode": "72162-1058-3",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1058-3) ",
"NDC11Code": "72162-1058-03",
"ProductNDC": "72162-1058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090776",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "72162-1059-3",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-3) ",
"NDC11Code": "72162-1059-03",
"ProductNDC": "72162-1059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078056",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"Description": "Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2."
},
{
"NDCCode": "72162-1076-3",
"PackageDescription": "360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1076-3) ",
"NDC11Code": "72162-1076-03",
"ProductNDC": "72162-1076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208864",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules, USP, are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. 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. Inactive ingredients: ethylcellulose, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide and edible black ink. The 10 mEq capsules also contain black iron oxide, FD&C blue No.1 and FD&C red No.3."
},
{
"NDCCode": "72162-1077-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (72162-1077-3) ",
"NDC11Code": "72162-1077-03",
"ProductNDC": "72162-1077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040230",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, FD&C Blue No. 1, and FD&C Red No. 3. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue No.1 Aluminum Lake."
},
{
"NDCCode": "72162-1080-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (72162-1080-3) ",
"NDC11Code": "72162-1080-03",
"ProductNDC": "72162-1080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077241",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72162-2351-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72162-2351-3) </PackageDescription>
<NDC11Code>72162-2351-03</NDC11Code>
<ProductNDC>72162-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090533</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine sulfate tablets, USP are indicated for: 1 Narcolepsy., 2 Attention Deficit Disorder with Hyperactivity:As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. .</IndicationAndUsage>
<Description>Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:. (C 9H 13N) 2∙H 2SO 4M.W.368.49.</Description>
</NDC>
<NDC>
<NDCCode>15631-2351-3</NDCCode>
<PackageDescription>100 TABLET in 1 CONTAINER (15631-2351-3)</PackageDescription>
<NDC11Code>15631-2351-03</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-2351-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2351-3)</PackageDescription>
<NDC11Code>36987-2351-03</NDC11Code>
<ProductNDC>36987-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Para Grass Pollen</ProprietaryName>
<NonProprietaryName>Para Grass Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>UROCHLOA MUTICA POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2351-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-2351-3) </PackageDescription>
<NDC11Code>37662-2351-03</NDC11Code>
<ProductNDC>37662-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Piper Methysticum</ProprietaryName>
<NonProprietaryName>Piper Methysticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230112</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>PIPER METHYSTICUM ROOT</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-2351-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-2351-3) </PackageDescription>
<NDC11Code>53002-2351-03</NDC11Code>
<ProductNDC>53002-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203245</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)Chronic Stable AnginaVasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate Tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>54868-2351-3</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (54868-2351-3)</PackageDescription>
<NDC11Code>54868-2351-03</NDC11Code>
<ProductNDC>54868-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotensin</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019851</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Lotensin is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40-mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (5-mg and 40-mg tablets), starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63629-2351-1</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (63629-2351-1) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63629-2351-01</NDC11Code>
<ProductNDC>63629-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-lo- Estarylla</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091232</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active white tablet contains 0.18 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide. , 2 Each active light blue tablet contains 0.215 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate and 0.025 mg of ethinyl estradiol. Inactive ingredients include crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Blue No.1 brilliant blue aluminum lake, FD&C Yellow No.6 sunset yellow fcf aluminum lake, lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide., 4 Each green placebo tablet contains only inert ingredients, as follows: crospovidone, FD&C Blue No.2 indigo carmine aluminum lake, FD&C Yellow No.5 tartrazine aluminum lake, lactose anhydrous, lecithin (soya), magnesium stearate, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70518-2351-0</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (70518-2351-0) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>70518-2351-00</NDC11Code>
<ProductNDC>70518-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20191007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077559</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE; IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>2.5; .5</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-2351-3</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-3) </PackageDescription>
<NDC11Code>71335-2351-03</NDC11Code>
<ProductNDC>71335-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0378-2351-77</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-77) </PackageDescription>
<NDC11Code>00378-2351-77</NDC11Code>
<ProductNDC>0378-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150803</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078936</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151207</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0378-2351-93</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-93) </PackageDescription>
<NDC11Code>00378-2351-93</NDC11Code>
<ProductNDC>0378-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150803</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078936</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150803</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>15631-2351-0</NDCCode>
<PackageDescription>1 TABLET in 1 BLISTER PACK (15631-2351-0)</PackageDescription>
<NDC11Code>15631-2351-00</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2351-1</NDCCode>
<PackageDescription>4 TABLET in 1 BLISTER PACK (15631-2351-1)</PackageDescription>
<NDC11Code>15631-2351-01</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2351-2</NDCCode>
<PackageDescription>50 TABLET in 1 CONTAINER (15631-2351-2)</PackageDescription>
<NDC11Code>15631-2351-02</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2351-4</NDCCode>
<PackageDescription>250 TABLET in 1 CONTAINER (15631-2351-4)</PackageDescription>
<NDC11Code>15631-2351-04</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2351-5</NDCCode>
<PackageDescription>500 TABLET in 1 CONTAINER (15631-2351-5)</PackageDescription>
<NDC11Code>15631-2351-05</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2351-6</NDCCode>
<PackageDescription>1000 TABLET in 1 CONTAINER (15631-2351-6)</PackageDescription>
<NDC11Code>15631-2351-06</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2351-7</NDCCode>
<PackageDescription>10000 TABLET in 1 CONTAINER (15631-2351-7)</PackageDescription>
<NDC11Code>15631-2351-07</NDC11Code>
<ProductNDC>15631-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Five Phos</ProprietaryName>
<NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53002-2351-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (53002-2351-0) </PackageDescription>
<NDC11Code>53002-2351-00</NDC11Code>
<ProductNDC>53002-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203245</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease (1.2)Chronic Stable AnginaVasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate Tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>54868-2351-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (54868-2351-0)</PackageDescription>
<NDC11Code>54868-2351-00</NDC11Code>
<ProductNDC>54868-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotensin</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019851</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Lotensin is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40-mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (5-mg and 40-mg tablets), starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-2351-2</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (54868-2351-2)</PackageDescription>
<NDC11Code>54868-2351-02</NDC11Code>
<ProductNDC>54868-2351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotensin</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019851</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Lotensin is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, hydrogenated castor oil (5-mg, 10-mg, and 20-mg tablets), hypromellose, iron oxides, lactose, magnesium stearate (40-mg tablets), microcrystalline cellulose, polysorbate 80, propylene glycol (5-mg and 40-mg tablets), starch, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55714-2351-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-2351-0)</PackageDescription>
<NDC11Code>55714-2351-00</NDC11Code>
<ProductNDC>55714-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitiligo</ProprietaryName>
<NonProprietaryName>Arsenicum Alb., Berber. Vulg., Bovista, Dolichos, Echinacea, Hura Brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus Toxicodendron, Rumex Crisp., Sepia, Taraxacum,thuja Occ., Urtica Ur., Iris Versicolor</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitiligo Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-2351-1</NDCCode>
<PackageDescription>28.35 g in 1 BOTTLE, GLASS (55714-2351-1)</PackageDescription>
<NDC11Code>55714-2351-01</NDC11Code>
<ProductNDC>55714-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitiligo</ProprietaryName>
<NonProprietaryName>Arsenicum Alb., Berber. Vulg., Bovista, Dolichos, Echinacea, Hura Brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus Toxicodendron, Rumex Crisp., Sepia, Taraxacum,thuja Occ., Urtica Ur., Iris Versicolor</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitiligo Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-2351-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-2351-2)</PackageDescription>
<NDC11Code>55714-2351-02</NDC11Code>
<ProductNDC>55714-2351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitiligo</ProprietaryName>
<NonProprietaryName>Arsenicum Alb., Berber. Vulg., Bovista, Dolichos, Echinacea, Hura Brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus Toxicodendron, Rumex Crisp., Sepia, Taraxacum,thuja Occ., Urtica Ur., Iris Versicolor</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitiligo Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72162-1054-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72162-1054-3) </PackageDescription>
<NDC11Code>72162-1054-03</NDC11Code>
<ProductNDC>72162-1054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087479</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows:. C 21H 27CIN 2O 2C 23H 16O 6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>72162-1058-3</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1058-3) </PackageDescription>
<NDC11Code>72162-1058-03</NDC11Code>
<ProductNDC>72162-1058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090776</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is. C18H19NOSHCl M.W. 333.88. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72162-1059-3</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-3) </PackageDescription>
<NDC11Code>72162-1059-03</NDC11Code>
<ProductNDC>72162-1059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078056</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72162-1076-3</NDCCode>
<PackageDescription>360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1076-3) </PackageDescription>
<NDC11Code>72162-1076-03</NDC11Code>
<ProductNDC>72162-1076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208864</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release capsules, USP, are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. 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. Inactive ingredients: ethylcellulose, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide and edible black ink. The 10 mEq capsules also contain black iron oxide, FD&C blue No.1 and FD&C red No.3.</Description>
</NDC>
<NDC>
<NDCCode>72162-1077-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72162-1077-3) </PackageDescription>
<NDC11Code>72162-1077-03</NDC11Code>
<ProductNDC>72162-1077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040230</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, FD&C Blue No. 1, and FD&C Red No. 3. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue No.1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72162-1080-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (72162-1080-3) </PackageDescription>
<NDC11Code>72162-1080-03</NDC11Code>
<ProductNDC>72162-1080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077241</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
</NDCList>