{
"NDC": [
{
"NDCCode": "70710-1039-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-3) ",
"NDC11Code": "70710-1039-03",
"ProductNDC": "70710-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208949",
"LabelerName": "Zydus Pharmaceuticals 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": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230117",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70710-1039-9",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-9) ",
"NDC11Code": "70710-1039-09",
"ProductNDC": "70710-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208949",
"LabelerName": "Zydus Pharmaceuticals 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": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230117",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0536-1039-81",
"PackageDescription": "3 BOTTLE in 1 CARTON (0536-1039-81) > 27 LOZENGE in 1 BOTTLE",
"NDC11Code": "00536-1039-81",
"ProductNDC": "0536-1039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rugby Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20141204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203690",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "36987-1039-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1039-3)",
"NDC11Code": "36987-1039-03",
"ProductNDC": "36987-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Goose Feathers",
"NonProprietaryName": "Goose Feathers",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ANSER ANSER FEATHER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1039-3",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-1039-3) ",
"NDC11Code": "37662-1039-03",
"ProductNDC": "37662-1039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lycopus Virginicus",
"NonProprietaryName": "Lycopus Virginicus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220722",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "LYCOPUS VIRGINICUS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220722",
"SamplePackage": "N"
},
{
"NDCCode": "53002-1039-3",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, DROPPER (53002-1039-3) ",
"NDC11Code": "53002-1039-03",
"ProductNDC": "53002-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181119",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210733",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240101",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N"
},
{
"NDCCode": "67046-1039-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-1039-3) ",
"NDC11Code": "67046-1039-03",
"ProductNDC": "67046-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040907",
"LabelerName": "Coupler LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241112",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "68745-1039-3",
"PackageDescription": ".9 mL in 1 PACKET (68745-1039-3)",
"NDC11Code": "68745-1039-03",
"ProductNDC": "68745-1039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitalumiere",
"ProprietaryNameSuffix": "Moisture-rich Radiance Sunscreen Fluid Makeup, Broad Spectrum Spf 15, 35 Soft Bisque",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CHANEL PARFUMS BEAUTE",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-04-09",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "70771-1039-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1039-3) ",
"NDC11Code": "70771-1039-03",
"ProductNDC": "70771-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "71335-1039-3",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71335-1039-3) ",
"NDC11Code": "71335-1039-03",
"ProductNDC": "71335-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960607",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074701",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROCHLOROTHIAZIDE; TRIAMTERENE",
"StrengthNumber": "25; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190910",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "11822-1039-0",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (11822-1039-0) ",
"NDC11Code": "11822-1039-00",
"ProductNDC": "11822-1039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength",
"ProprietaryNameSuffix": "Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20191118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "RITE AID CORPORATION",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191118",
"SamplePackage": "N",
"IndicationAndUsage": "relieves : 1 heartburn, 2 acid indigestion, 3 sour stomach , 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "43742-1039-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1039-1) ",
"NDC11Code": "43742-1039-01",
"ProductNDC": "43742-1039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healing Support",
"NonProprietaryName": "Betula (pendula) Cortex, Caltha Palustris, Galium Aparine, Thuja Occidentalis, Urtica Urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea (angustifolia), Nitricum Acidum, Argentum Metallicum, Calcarea Fluorica, Sedum Acre, Phosphorus, Apis Mellifica, Pyrogenium, Ononis Spinosa",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170721",
"EndMarketingDate": "20230508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; NITRIC ACID; ONONIS SPINOSA WHOLE; PHOSPHORUS; QUILLAJA SAPONARIA BARK; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS",
"StrengthNumber": "12; 1; 8; 3; 4; 5; 3; 4; 4; 6; 5; 9; 4; 12; 8; 4; 8; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170721",
"EndMarketingDatePackage": "20230508",
"SamplePackage": "N"
},
{
"NDCCode": "50090-1039-0",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (50090-1039-0) ",
"NDC11Code": "50090-1039-00",
"ProductNDC": "50090-1039",
"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": "A-S Medication Solutions",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"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": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"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 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 is available as capsules containing amlodipine besylate USP (3.5 mg, 6.9 mg or 13.9 mg, equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine respectively), with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride USP 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": "50536-139-01",
"PackageDescription": "3785 mL in 1 JUG (50536-139-01) ",
"NDC11Code": "50536-0139-01",
"ProductNDC": "50536-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Touch Plus Antibacterial Hand",
"ProprietaryNameSuffix": "Item 1039",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140312",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "AMERICAN CHEMICAL AND SANITARY SUPPLY INC",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140312",
"SamplePackage": "N",
"IndicationAndUsage": "Handwash to help decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "50536-139-08",
"PackageDescription": "800 mL in 1 BOTTLE (50536-139-08) ",
"NDC11Code": "50536-0139-08",
"ProductNDC": "50536-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Touch Plus Antibacterial Hand",
"ProprietaryNameSuffix": "Item 1039",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140312",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "AMERICAN CHEMICAL AND SANITARY SUPPLY INC",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140312",
"SamplePackage": "N",
"IndicationAndUsage": "Handwash to help decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "53808-1039-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-1039-1)",
"NDC11Code": "53808-1039-01",
"ProductNDC": "53808-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077563",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Cyclobenzaprine Hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine Hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine Hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCI and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine Hydrochloride tablets, for oral administration, are available in the following strengths: 5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow. Cyclobenzaprine Hydrochloride Tablets 5 mg also contains FD&C yellow #6."
},
{
"NDCCode": "70710-1000-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1000-3) ",
"NDC11Code": "70710-1000-03",
"ProductNDC": "70710-1000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1001-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1001-3) ",
"NDC11Code": "70710-1001-03",
"ProductNDC": "70710-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1002-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1002-3) ",
"NDC11Code": "70710-1002-03",
"ProductNDC": "70710-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1011-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-3) ",
"NDC11Code": "70710-1011-03",
"ProductNDC": "70710-1011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1012-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3) ",
"NDC11Code": "70710-1012-03",
"ProductNDC": "70710-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1013-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1013-3) ",
"NDC11Code": "70710-1013-03",
"ProductNDC": "70710-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1014-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (70710-1014-3) ",
"NDC11Code": "70710-1014-03",
"ProductNDC": "70710-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210189",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "Y",
"IndicationAndUsage": "Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "70710-1021-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (70710-1021-3) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70710-1021-03",
"ProductNDC": "70710-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albendazole",
"NonProprietaryName": "Albendazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208979",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ALBENDAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200527",
"SamplePackage": "N",
"IndicationAndUsage": "Albendazole tablets are an anthelmintic drug indicated for: 1 Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2 Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).",
"Description": "Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5 - (propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride, practically insoluble in alcohol and water. Each film-coated tablet contains albendazole USP, 200 mg and inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone K-30, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate type A (botanical source: potato), talc and titanium dioxide."
},
{
"NDCCode": "70710-1022-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1022-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1022-08",
"ProductNDC": "70710-1022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1023-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1023-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1023-08",
"ProductNDC": "70710-1023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1024-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1024-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1024-08",
"ProductNDC": "70710-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1025-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1025-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1025-08",
"ProductNDC": "70710-1025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1040-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1040-3) ",
"NDC11Code": "70710-1040-03",
"ProductNDC": "70710-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208949",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"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": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230117",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70710-1041-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-3) ",
"NDC11Code": "70710-1041-03",
"ProductNDC": "70710-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208949",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"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": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230117",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70710-1039-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-3) </PackageDescription>
<NDC11Code>70710-1039-03</NDC11Code>
<ProductNDC>70710-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208949</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals 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>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70710-1039-9</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-9) </PackageDescription>
<NDC11Code>70710-1039-09</NDC11Code>
<ProductNDC>70710-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208949</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals 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>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0536-1039-81</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (0536-1039-81) > 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>00536-1039-81</NDC11Code>
<ProductNDC>0536-1039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rugby Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203690</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>36987-1039-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1039-3)</PackageDescription>
<NDC11Code>36987-1039-03</NDC11Code>
<ProductNDC>36987-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Goose Feathers</ProprietaryName>
<NonProprietaryName>Goose Feathers</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ANSER ANSER FEATHER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1039-3</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-1039-3) </PackageDescription>
<NDC11Code>37662-1039-03</NDC11Code>
<ProductNDC>37662-1039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lycopus Virginicus</ProprietaryName>
<NonProprietaryName>Lycopus Virginicus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220722</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>LYCOPUS VIRGINICUS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-1039-3</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, DROPPER (53002-1039-3) </PackageDescription>
<NDC11Code>53002-1039-03</NDC11Code>
<ProductNDC>53002-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181119</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210733</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67046-1039-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-1039-3) </PackageDescription>
<NDC11Code>67046-1039-03</NDC11Code>
<ProductNDC>67046-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040907</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>68745-1039-3</NDCCode>
<PackageDescription>.9 mL in 1 PACKET (68745-1039-3)</PackageDescription>
<NDC11Code>68745-1039-03</NDC11Code>
<ProductNDC>68745-1039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitalumiere</ProprietaryName>
<ProprietaryNameSuffix>Moisture-rich Radiance Sunscreen Fluid Makeup, Broad Spectrum Spf 15, 35 Soft Bisque</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CHANEL PARFUMS BEAUTE</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70771-1039-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1039-3) </PackageDescription>
<NDC11Code>70771-1039-03</NDC11Code>
<ProductNDC>70771-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiadylt Er</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206641</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18.</Description>
</NDC>
<NDC>
<NDCCode>71335-1039-3</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71335-1039-3) </PackageDescription>
<NDC11Code>71335-1039-03</NDC11Code>
<ProductNDC>71335-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960607</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074701</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; TRIAMTERENE</SubstanceName>
<StrengthNumber>25; 37.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11822-1039-0</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (11822-1039-0) </PackageDescription>
<NDC11Code>11822-1039-00</NDC11Code>
<ProductNDC>11822-1039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength</ProprietaryName>
<ProprietaryNameSuffix>Antacid</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>RITE AID CORPORATION</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves : 1 heartburn, 2 acid indigestion, 3 sour stomach , 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43742-1039-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1039-1) </PackageDescription>
<NDC11Code>43742-1039-01</NDC11Code>
<ProductNDC>43742-1039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healing Support</ProprietaryName>
<NonProprietaryName>Betula (pendula) Cortex, Caltha Palustris, Galium Aparine, Thuja Occidentalis, Urtica Urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea (angustifolia), Nitricum Acidum, Argentum Metallicum, Calcarea Fluorica, Sedum Acre, Phosphorus, Apis Mellifica, Pyrogenium, Ononis Spinosa</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170721</StartMarketingDate>
<EndMarketingDate>20230508</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; NITRIC ACID; ONONIS SPINOSA WHOLE; PHOSPHORUS; QUILLAJA SAPONARIA BARK; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS</SubstanceName>
<StrengthNumber>12; 1; 8; 3; 4; 5; 3; 4; 4; 6; 5; 9; 4; 12; 8; 4; 8; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170721</StartMarketingDatePackage>
<EndMarketingDatePackage>20230508</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-1039-0</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (50090-1039-0) </PackageDescription>
<NDC11Code>50090-1039-00</NDC11Code>
<ProductNDC>50090-1039</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>A-S Medication Solutions</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</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>Deprecated</Status>
<LastUpdate>2025-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</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 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 is available as capsules containing amlodipine besylate USP (3.5 mg, 6.9 mg or 13.9 mg, equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine respectively), with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride USP 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>50536-139-01</NDCCode>
<PackageDescription>3785 mL in 1 JUG (50536-139-01) </PackageDescription>
<NDC11Code>50536-0139-01</NDC11Code>
<ProductNDC>50536-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Touch Plus Antibacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Item 1039</ProprietaryNameSuffix>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140312</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>AMERICAN CHEMICAL AND SANITARY SUPPLY INC</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Handwash to help decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50536-139-08</NDCCode>
<PackageDescription>800 mL in 1 BOTTLE (50536-139-08) </PackageDescription>
<NDC11Code>50536-0139-08</NDC11Code>
<ProductNDC>50536-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Touch Plus Antibacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Item 1039</ProprietaryNameSuffix>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140312</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>AMERICAN CHEMICAL AND SANITARY SUPPLY INC</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Handwash to help decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53808-1039-1</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (53808-1039-1)</PackageDescription>
<NDC11Code>53808-1039-01</NDC11Code>
<ProductNDC>53808-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077563</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine Hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine Hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine Hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCI and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine Hydrochloride tablets, for oral administration, are available in the following strengths: 5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow. Cyclobenzaprine Hydrochloride Tablets 5 mg also contains FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>70710-1000-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1000-3) </PackageDescription>
<NDC11Code>70710-1000-03</NDC11Code>
<ProductNDC>70710-1000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1001-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1001-3) </PackageDescription>
<NDC11Code>70710-1001-03</NDC11Code>
<ProductNDC>70710-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1002-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1002-3) </PackageDescription>
<NDC11Code>70710-1002-03</NDC11Code>
<ProductNDC>70710-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1011-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-3) </PackageDescription>
<NDC11Code>70710-1011-03</NDC11Code>
<ProductNDC>70710-1011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1012-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3) </PackageDescription>
<NDC11Code>70710-1012-03</NDC11Code>
<ProductNDC>70710-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1013-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1013-3) </PackageDescription>
<NDC11Code>70710-1013-03</NDC11Code>
<ProductNDC>70710-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1014-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70710-1014-3) </PackageDescription>
<NDC11Code>70710-1014-03</NDC11Code>
<ProductNDC>70710-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210189</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>70710-1021-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (70710-1021-3) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1021-03</NDC11Code>
<ProductNDC>70710-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albendazole</ProprietaryName>
<NonProprietaryName>Albendazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208979</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ALBENDAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albendazole tablets are an anthelmintic drug indicated for: 1 Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2 Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).</IndicationAndUsage>
<Description>Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5 - (propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride, practically insoluble in alcohol and water. Each film-coated tablet contains albendazole USP, 200 mg and inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone K-30, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate type A (botanical source: potato), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1022-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1022-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1022-08</NDC11Code>
<ProductNDC>70710-1022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
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<NDC>
<NDCCode>70710-1023-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1023-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
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<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
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<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
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<NDCCode>70710-1024-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1024-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1024-08</NDC11Code>
<ProductNDC>70710-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1025-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1025-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1025-08</NDC11Code>
<ProductNDC>70710-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1040-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1040-3) </PackageDescription>
<NDC11Code>70710-1040-03</NDC11Code>
<ProductNDC>70710-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208949</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</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>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70710-1041-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1041-3) </PackageDescription>
<NDC11Code>70710-1041-03</NDC11Code>
<ProductNDC>70710-1041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208949</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</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>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules 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 extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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