{
"NDC": [
{
"NDCCode": "71205-122-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-122-60) ",
"NDC11Code": "71205-0122-60",
"ProductNDC": "71205-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202239",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white, crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-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 molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4‑-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. In addition, the hard gelatin capsule shells of 5 mg/10 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 5 mg/20 mg contains iron oxide red, 5 mg/40 mg and 10 mg/40 mg contains FD&C Blue 1, FD&C Red 3, and 10 mg/20 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, and FD&C Yellow 5. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "71205-122-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71205-122-30) ",
"NDC11Code": "71205-0122-30",
"ProductNDC": "71205-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202239",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white, crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-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 molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4‑-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. In addition, the hard gelatin capsule shells of 5 mg/10 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 5 mg/20 mg contains iron oxide red, 5 mg/40 mg and 10 mg/40 mg contains FD&C Blue 1, FD&C Red 3, and 10 mg/20 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, and FD&C Yellow 5. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "71205-122-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71205-122-90) ",
"NDC11Code": "71205-0122-90",
"ProductNDC": "71205-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202239",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180904",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1).",
"Description": "Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white, crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-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 molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4‑-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. In addition, the hard gelatin capsule shells of 5 mg/10 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 5 mg/20 mg contains iron oxide red, 5 mg/40 mg and 10 mg/40 mg contains FD&C Blue 1, FD&C Red 3, and 10 mg/20 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, and FD&C Yellow 5. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "12714-122-01",
"PackageDescription": "60 TABLET in 1 BOTTLE (12714-122-01) ",
"NDC11Code": "12714-0122-01",
"ProductNDC": "12714-122",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Nerandomilast",
"DosageFormName": "TABLET",
"StartMarketingDate": "20251007",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
"SubstanceName": "NERANDOMILAST",
"StrengthNumber": "9",
"StrengthUnit": "mg/91",
"Status": "Unfinished",
"LastUpdate": "2026-02-25",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "07-OCT-25"
},
{
"NDCCode": "13107-122-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (13107-122-60)",
"NDC11Code": "13107-0122-60",
"ProductNDC": "13107-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078269",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13925-122-60",
"PackageDescription": "1 KIT in 1 CARTON (13925-122-60) * 5 TABLET in 1 BLISTER PACK * 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "13925-0122-60",
"ProductNDC": "13925-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cavan-ec Sod Dha",
"NonProprietaryName": "Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iodine, Omega-3 Fatty Acids",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20100110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Seton Pharmaceuticals",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "21130-122-02",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (21130-122-02) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "21130-0122-02",
"ProductNDC": "21130-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Childrens Allergy Relief",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20170620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "Safeway",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170620",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "43269-122-60",
"PackageDescription": ".1 mL in 1 POUCH (43269-122-60) ",
"NDC11Code": "43269-0122-60",
"ProductNDC": "43269-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200929",
"EndMarketingDate": "20221201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200929",
"EndMarketingDatePackage": "20221201",
"SamplePackage": "N"
},
{
"NDCCode": "45802-122-60",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (45802-122-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "45802-0122-60",
"ProductNDC": "45802-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine D",
"NonProprietaryName": "Loratadine, Pseudoephedrine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076050",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"StrengthNumber": "5; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itchy, watery eyes. runny nose. itching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
},
{
"NDCCode": "45865-122-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (45865-122-60) ",
"NDC11Code": "45865-0122-60",
"ProductNDC": "45865-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203244",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140111",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin and copovidone, hydroxyl propyl cellulose, magnesium stearate, mannitol, poloxamer, talc, low-substituted hydroxypropyl cellulose and opadry II (white). Opadry II (white) contains polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc."
},
{
"NDCCode": "49999-122-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49999-122-60)",
"NDC11Code": "49999-0122-60",
"ProductNDC": "49999-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072927",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55111-122-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (55111-122-60) ",
"NDC11Code": "55111-0122-60",
"ProductNDC": "55111-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091650",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose."
},
{
"NDCCode": "59726-122-60",
"PackageDescription": "1 CAN in 1 PACKAGE (59726-122-60) / 60 g in 1 CAN",
"NDC11Code": "59726-0122-60",
"ProductNDC": "59726-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208092",
"LabelerName": "P & L Development, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (see pictures on side of this carton)."
},
{
"NDCCode": "60760-122-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (60760-122-60)",
"NDC11Code": "60760-0122-60",
"ProductNDC": "60760-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "St Marys Medical Park Pharmacy",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "61328-122-11",
"PackageDescription": "60 g in 1 TUBE (61328-122-11) ",
"NDC11Code": "61328-0122-11",
"ProductNDC": "61328-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Targeted Body Balm",
"NonProprietaryName": "Oatmeal",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150523",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Skinfix, Inc.",
"SubstanceName": "OATMEAL",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181226",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis."
},
{
"NDCCode": "62980-122-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (62980-122-03)",
"NDC11Code": "62980-0122-03",
"ProductNDC": "62980-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090073",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "63187-122-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-60) ",
"NDC11Code": "63187-0122-60",
"ProductNDC": "63187-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orphenadrine Citrate",
"NonProprietaryName": "Orphenadrine Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19980619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040284",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ORPHENADRINE CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150202",
"SamplePackage": "N",
"IndicationAndUsage": "Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.",
"Description": "Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-〈-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NOC6H8O7 and molecular weight of 461.51. It has the following structural formula. Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "64679-122-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (64679-122-03) ",
"NDC11Code": "64679-0122-03",
"ProductNDC": "64679-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090073",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "65862-122-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (65862-122-60) ",
"NDC11Code": "65862-0122-60",
"ProductNDC": "65862-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078269",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20081008",
"SamplePackage": "N"
},
{
"NDCCode": "66761-122-60",
"PackageDescription": "1 TUBE in 1 BOX (66761-122-60) > 57 g in 1 TUBE",
"NDC11Code": "66761-0122-60",
"ProductNDC": "66761-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tiger Balm",
"ProprietaryNameSuffix": "Muscle Rub Pain Relieving",
"NonProprietaryName": "Methyl Salicylate, Menthol, And Camphor (synthetic)",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130501",
"EndMarketingDate": "20201130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Haw Par Healthcare Ltd.",
"SubstanceName": "METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "150; 50; 30",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130501",
"EndMarketingDatePackage": "20201130",
"SamplePackage": "N"
},
{
"NDCCode": "69097-122-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (69097-122-03) ",
"NDC11Code": "69097-0122-03",
"ProductNDC": "69097-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076343",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140612",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, and 100 mg circular tablets and 200 mg capsule shaped tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula:. Each tablet, for oral administration, contains 25 mg, 50 mg, 100 mg and 200 mg topiramate and has the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. In addition, the 25 mg also contains FD&C Blue#2; the 50 mg and 100 mg also contain red iron oxide and yellow iron oxide; and the 200 mg also contains red iron oxide."
},
{
"NDCCode": "69233-122-02",
"PackageDescription": "1 JAR in 1 BOX (69233-122-02) / 60 mL in 1 JAR",
"NDC11Code": "69233-0122-02",
"ProductNDC": "69233-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Syren Intimate Pain Relief",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200110",
"EndMarketingDate": "20260201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Icon Health Science, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200110",
"EndMarketingDatePackage": "20260201",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain (and itching) associated with minor, burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations."
},
{
"NDCCode": "71610-122-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (71610-122-53) ",
"NDC11Code": "71610-0122-53",
"ProductNDC": "71610-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078203",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181003",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose and polacrilin potassium."
},
{
"NDCCode": "71610-122-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-122-60) ",
"NDC11Code": "71610-0122-60",
"ProductNDC": "71610-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078203",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181003",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose and polacrilin potassium."
},
{
"NDCCode": "71863-122-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (71863-122-60) / 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "71863-0122-60",
"ProductNDC": "71863-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitisinone",
"NonProprietaryName": "Nitisinone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216201",
"LabelerName": "Eton Pharmaceuticals, Inc.",
"SubstanceName": "NITISINONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240115",
"SamplePackage": "N",
"IndicationAndUsage": "Nitisinone Capsules is indicated for the treatment of adult and pediatric patients with. hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and. phenylalanine.",
"Description": "Nitisinone capsules contain nitisinone, which is a 4-hydroxyphenyl-pyruvate dioxygenase. inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the. treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to yellowish-white, crystalline powder. It is Freely soluble in. Acetone, Ethyl acetate and Methylene chloride. Sparingly soluble in absolute alcohol and. practically insoluble in water Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl)-. 1,3-cyclohexanedione, and the structural formula is. Figure 1. The molecular formula is C14H10F3NO5 with a relative mass of 329.23. Capsules: Hard, white-opaque capsule, 2 mg, 5 mg, 10 mg, and 20 mg strengths of nitisinone. intended for oral administration. Each capsule contains 2 mg, 5 mg, 10 mg, or 20 mg. nitisinone, anhydrous lactose and stearic acid. The capsule shell contains gelatin and titanium. dioxide, and the imprinting ink contains black iron oxide, propylene glycol, potassium. hydroxide, shellac, and strong ammonia solution."
},
{
"NDCCode": "72189-122-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72189-122-60) ",
"NDC11Code": "72189-0122-60",
"ProductNDC": "72189-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "DIRECT RX",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200729",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See CLINICAL STUDIES (14)]. Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: [Chemical Structure] Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "72579-122-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (72579-122-01) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "72579-0122-01",
"ProductNDC": "72579-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brukinsa",
"NonProprietaryName": "Zanubrutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218785",
"LabelerName": "BeOne Medicines USA, Inc.",
"SubstanceName": "ZANUBRUTINIB",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250818",
"SamplePackage": "N",
"IndicationAndUsage": "BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Mantle cell lymphoma (MCL) who have received at least one prior therapy. (1.1) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial., 2 Waldenström's macroglobulinemia (WM). (1.2), 3 Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. (1.3) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial., 4 Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.4), 5 Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. (1.5)This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
"Description": "BRUKINSA (zanubrutinib) is a kinase inhibitor. The empirical formula of zanubrutinib is C27H29N5O3 and the chemical name is (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide. Zanubrutinib is a white to off-white powder, with a pH of 7.8 in saturated solution. The aqueous solubility of zanubrutinib is pH dependent, from very slightly soluble to practically insoluble. The molecular weight of zanubrutinib is 471.55 Daltons. Zanubrutinib has the following structure. Each BRUKINSA capsule for oral administration contains 80 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell contains edible black ink, gelatin, and titanium dioxide. Each BRUKINSA tablet for oral administration contains 160 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating contains FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, titanium dioxide, and triacetin."
},
{
"NDCCode": "76413-122-60",
"PackageDescription": "1 TUBE in 1 CARTON (76413-122-60) > 60 g in 1 TUBE",
"NDC11Code": "76413-0122-60",
"ProductNDC": "76413-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Permethrin",
"NonProprietaryName": "Permethrin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076369",
"LabelerName": "Central Texas Community Health Centers",
"SubstanceName": "PERMETHRIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Pyrethrins [CS],Pyrethroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).",
"Description": "Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream, 5% is for topical use only. Chemical Name – The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C21H20Cl2O3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid. Active Ingredient – Each gram contains permethrin 50 mg (5%). Inactive Ingredients – Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative."
},
{
"NDCCode": "76420-122-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (76420-122-60) ",
"NDC11Code": "76420-0122-60",
"ProductNDC": "76420-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210432",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2020-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white or almost white powder with a pK a1 of 4.4 and a pK a2 of 10.1. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (Octanol : Water) is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange & red capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "78794-122-01",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (78794-122-01) ",
"NDC11Code": "78794-0122-01",
"ProductNDC": "78794-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ready4life Hand Sanitizer Gel Uscented",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200709",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Hand 2 Hand Industries, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73.0166",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200709",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Benazepril Hydrochloride</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202239</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
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<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<Description>Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white, crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-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 molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4‑-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. In addition, the hard gelatin capsule shells of 5 mg/10 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 5 mg/20 mg contains iron oxide red, 5 mg/40 mg and 10 mg/40 mg contains FD&C Blue 1, FD&C Red 3, and 10 mg/20 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, and FD&C Yellow 5. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
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<NDC>
<NDCCode>71205-122-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71205-122-30) </PackageDescription>
<NDC11Code>71205-0122-30</NDC11Code>
<ProductNDC>71205-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Benazepril Hydrochloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202239</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white, crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-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 molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4‑-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. In addition, the hard gelatin capsule shells of 5 mg/10 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 5 mg/20 mg contains iron oxide red, 5 mg/40 mg and 10 mg/40 mg contains FD&C Blue 1, FD&C Red 3, and 10 mg/20 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, and FD&C Yellow 5. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71205-122-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71205-122-90) </PackageDescription>
<NDC11Code>71205-0122-90</NDC11Code>
<ProductNDC>71205-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202239</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white, crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-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 molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4‑-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide. In addition, the hard gelatin capsule shells of 5 mg/10 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 5 mg/20 mg contains iron oxide red, 5 mg/40 mg and 10 mg/40 mg contains FD&C Blue 1, FD&C Red 3, and 10 mg/20 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, and FD&C Yellow 5. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>12714-122-01</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (12714-122-01) </PackageDescription>
<NDC11Code>12714-0122-01</NDC11Code>
<ProductNDC>12714-122</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Nerandomilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20251007</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
<SubstanceName>NERANDOMILAST</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/91</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-25</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-OCT-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13107-122-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (13107-122-60)</PackageDescription>
<NDC11Code>13107-0122-60</NDC11Code>
<ProductNDC>13107-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078269</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13925-122-60</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (13925-122-60) * 5 TABLET in 1 BLISTER PACK * 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>13925-0122-60</NDC11Code>
<ProductNDC>13925-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cavan-ec Sod Dha</ProprietaryName>
<NonProprietaryName>Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iodine, Omega-3 Fatty Acids</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Seton Pharmaceuticals</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>21130-122-02</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (21130-122-02) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>21130-0122-02</NDC11Code>
<ProductNDC>21130-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Childrens Allergy Relief</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170620</StartMarketingDatePackage>
<EndMarketingDatePackage>20220101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43269-122-60</NDCCode>
<PackageDescription>.1 mL in 1 POUCH (43269-122-60) </PackageDescription>
<NDC11Code>43269-0122-60</NDC11Code>
<ProductNDC>43269-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200929</StartMarketingDate>
<EndMarketingDate>20221201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200929</StartMarketingDatePackage>
<EndMarketingDatePackage>20221201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45802-122-60</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (45802-122-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0122-60</NDC11Code>
<ProductNDC>45802-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine D</ProprietaryName>
<NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076050</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>LORATADINE; PSEUDOEPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>5; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itchy, watery eyes. runny nose. itching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45865-122-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (45865-122-60) </PackageDescription>
<NDC11Code>45865-0122-60</NDC11Code>
<ProductNDC>45865-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203244</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin and copovidone, hydroxyl propyl cellulose, magnesium stearate, mannitol, poloxamer, talc, low-substituted hydroxypropyl cellulose and opadry II (white). Opadry II (white) contains polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>49999-122-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49999-122-60)</PackageDescription>
<NDC11Code>49999-0122-60</NDC11Code>
<ProductNDC>49999-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072927</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55111-122-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (55111-122-60) </PackageDescription>
<NDC11Code>55111-0122-60</NDC11Code>
<ProductNDC>55111-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091650</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>59726-122-60</NDCCode>
<PackageDescription>1 CAN in 1 PACKAGE (59726-122-60) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>59726-0122-60</NDC11Code>
<ProductNDC>59726-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208092</ApplicationNumber>
<LabelerName>P & L Development, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60760-122-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (60760-122-60)</PackageDescription>
<NDC11Code>60760-0122-60</NDC11Code>
<ProductNDC>60760-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>St Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>61328-122-11</NDCCode>
<PackageDescription>60 g in 1 TUBE (61328-122-11) </PackageDescription>
<NDC11Code>61328-0122-11</NDC11Code>
<ProductNDC>61328-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Targeted Body Balm</ProprietaryName>
<NonProprietaryName>Oatmeal</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150523</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Skinfix, Inc.</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62980-122-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62980-122-03)</PackageDescription>
<NDC11Code>62980-0122-03</NDC11Code>
<ProductNDC>62980-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090073</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>63187-122-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-60) </PackageDescription>
<NDC11Code>63187-0122-60</NDC11Code>
<ProductNDC>63187-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orphenadrine Citrate</ProprietaryName>
<NonProprietaryName>Orphenadrine Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040284</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ORPHENADRINE CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.</IndicationAndUsage>
<Description>Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-〈-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NOC6H8O7 and molecular weight of 461.51. It has the following structural formula. Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>64679-122-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (64679-122-03) </PackageDescription>
<NDC11Code>64679-0122-03</NDC11Code>
<ProductNDC>64679-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090073</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>65862-122-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65862-122-60) </PackageDescription>
<NDC11Code>65862-0122-60</NDC11Code>
<ProductNDC>65862-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078269</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66761-122-60</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (66761-122-60) > 57 g in 1 TUBE</PackageDescription>
<NDC11Code>66761-0122-60</NDC11Code>
<ProductNDC>66761-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tiger Balm</ProprietaryName>
<ProprietaryNameSuffix>Muscle Rub Pain Relieving</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate, Menthol, And Camphor (synthetic)</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<EndMarketingDate>20201130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Haw Par Healthcare Ltd.</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>150; 50; 30</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130501</StartMarketingDatePackage>
<EndMarketingDatePackage>20201130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-122-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69097-122-03) </PackageDescription>
<NDC11Code>69097-0122-03</NDC11Code>
<ProductNDC>69097-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076343</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, and 100 mg circular tablets and 200 mg capsule shaped tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula:. Each tablet, for oral administration, contains 25 mg, 50 mg, 100 mg and 200 mg topiramate and has the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. In addition, the 25 mg also contains FD&C Blue#2; the 50 mg and 100 mg also contain red iron oxide and yellow iron oxide; and the 200 mg also contains red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>69233-122-02</NDCCode>
<PackageDescription>1 JAR in 1 BOX (69233-122-02) / 60 mL in 1 JAR</PackageDescription>
<NDC11Code>69233-0122-02</NDC11Code>
<ProductNDC>69233-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Syren Intimate Pain Relief</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<EndMarketingDate>20260201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Icon Health Science, LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200110</StartMarketingDatePackage>
<EndMarketingDatePackage>20260201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain (and itching) associated with minor, burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-122-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71610-122-53) </PackageDescription>
<NDC11Code>71610-0122-53</NDC11Code>
<ProductNDC>71610-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078203</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>71610-122-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-122-60) </PackageDescription>
<NDC11Code>71610-0122-60</NDC11Code>
<ProductNDC>71610-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078203</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>71863-122-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71863-122-60) / 60 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>71863-0122-60</NDC11Code>
<ProductNDC>71863-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitisinone</ProprietaryName>
<NonProprietaryName>Nitisinone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216201</ApplicationNumber>
<LabelerName>Eton Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITISINONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitisinone Capsules is indicated for the treatment of adult and pediatric patients with. hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and. phenylalanine.</IndicationAndUsage>
<Description>Nitisinone capsules contain nitisinone, which is a 4-hydroxyphenyl-pyruvate dioxygenase. inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the. treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to yellowish-white, crystalline powder. It is Freely soluble in. Acetone, Ethyl acetate and Methylene chloride. Sparingly soluble in absolute alcohol and. practically insoluble in water Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl)-. 1,3-cyclohexanedione, and the structural formula is. Figure 1. The molecular formula is C14H10F3NO5 with a relative mass of 329.23. Capsules: Hard, white-opaque capsule, 2 mg, 5 mg, 10 mg, and 20 mg strengths of nitisinone. intended for oral administration. Each capsule contains 2 mg, 5 mg, 10 mg, or 20 mg. nitisinone, anhydrous lactose and stearic acid. The capsule shell contains gelatin and titanium. dioxide, and the imprinting ink contains black iron oxide, propylene glycol, potassium. hydroxide, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>72189-122-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72189-122-60) </PackageDescription>
<NDC11Code>72189-0122-60</NDC11Code>
<ProductNDC>72189-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See CLINICAL STUDIES (14)]. Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: [Chemical Structure] Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>72579-122-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72579-122-01) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>72579-0122-01</NDC11Code>
<ProductNDC>72579-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brukinsa</ProprietaryName>
<NonProprietaryName>Zanubrutinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218785</ApplicationNumber>
<LabelerName>BeOne Medicines USA, Inc.</LabelerName>
<SubstanceName>ZANUBRUTINIB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Mantle cell lymphoma (MCL) who have received at least one prior therapy. (1.1) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial., 2 Waldenström's macroglobulinemia (WM). (1.2), 3 Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. (1.3) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial., 4 Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.4), 5 Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. (1.5)This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.</IndicationAndUsage>
<Description>BRUKINSA (zanubrutinib) is a kinase inhibitor. The empirical formula of zanubrutinib is C27H29N5O3 and the chemical name is (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide. Zanubrutinib is a white to off-white powder, with a pH of 7.8 in saturated solution. The aqueous solubility of zanubrutinib is pH dependent, from very slightly soluble to practically insoluble. The molecular weight of zanubrutinib is 471.55 Daltons. Zanubrutinib has the following structure. Each BRUKINSA capsule for oral administration contains 80 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell contains edible black ink, gelatin, and titanium dioxide. Each BRUKINSA tablet for oral administration contains 160 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating contains FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>76413-122-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (76413-122-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>76413-0122-60</NDC11Code>
<ProductNDC>76413-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Permethrin</ProprietaryName>
<NonProprietaryName>Permethrin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076369</ApplicationNumber>
<LabelerName>Central Texas Community Health Centers</LabelerName>
<SubstanceName>PERMETHRIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Pyrethrins [CS],Pyrethroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).</IndicationAndUsage>
<Description>Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream, 5% is for topical use only. Chemical Name – The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C21H20Cl2O3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid. Active Ingredient – Each gram contains permethrin 50 mg (5%). Inactive Ingredients – Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>76420-122-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (76420-122-60) </PackageDescription>
<NDC11Code>76420-0122-60</NDC11Code>
<ProductNDC>76420-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210432</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2020-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white or almost white powder with a pK a1 of 4.4 and a pK a2 of 10.1. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (Octanol : Water) is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange & red capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>78794-122-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (78794-122-01) </PackageDescription>
<NDC11Code>78794-0122-01</NDC11Code>
<ProductNDC>78794-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ready4life Hand Sanitizer Gel Uscented</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200709</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Hand 2 Hand Industries, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>73.0166</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
</NDCList>