{
"NDC": [
{
"NDCCode": "55111-596-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-596-05) ",
"NDC11Code": "55111-0596-05",
"ProductNDC": "55111-596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150711",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "68382-596-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-596-05) ",
"NDC11Code": "68382-0596-05",
"ProductNDC": "68382-596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206534",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181002",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). 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. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). Each capsule contains the following inactive ingredients: acetyl tributyl citrate, ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, colloidal silicon dioxide, gelatin, hypromellose, sodium lauryl sulfate, sugar sphere, talc and titanium dioxide. Additionally each 120 mg capsule shell contains D & C yellow # 10, FD & C blue # 1 and FD & C red # 40; each 180 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and iron oxide black; each 240 mg capsule shell contains FD & C blue # 1 and FD & C red # 3; each 300 mg capsule shell contains D & C yellow # 10, FD & C blue # 1, FD & C red # 40 and iron oxide black; each 360 mg capsule shell contains iron oxide black. 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. Diltiazem Hydrochloride Extended-release Capsule, USP meets USP Dissolution Test 3. For oral administration."
},
{
"NDCCode": "68428-596-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-596-05) ",
"NDC11Code": "68428-0596-05",
"ProductNDC": "68428-596",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ratanhia",
"NonProprietaryName": "Krameria Lappacea Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091028",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "KRAMERIA LAPPACEA ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20091028",
"SamplePackage": "N"
},
{
"NDCCode": "84756-596-05",
"PackageDescription": "100 g in 1 BOX (84756-596-05) ",
"NDC11Code": "84756-0596-05",
"ProductNDC": "84756-596",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dark Spot Correcting Cream",
"NonProprietaryName": "Dark Spot Correcting Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241211",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241211",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84827-596-05",
"PackageDescription": "100 g in 1 BOX (84827-596-05) ",
"NDC11Code": "84827-0596-05",
"ProductNDC": "84827-596",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Pearl Cream",
"NonProprietaryName": "Trstay Pearl Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241225",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241225",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "55111-596-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (55111-596-01) ",
"NDC11Code": "55111-0596-01",
"ProductNDC": "55111-596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150711",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "55111-596-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55111-596-30) ",
"NDC11Code": "55111-0596-30",
"ProductNDC": "55111-596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150711",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "55111-596-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55111-596-60) ",
"NDC11Code": "55111-0596-60",
"ProductNDC": "55111-596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150711",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "55111-596-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-596-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55111-0596-78",
"ProductNDC": "55111-596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150711",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "55111-596-79",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55111-596-79) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55111-0596-79",
"ProductNDC": "55111-596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150711",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "55111-112-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-112-05) ",
"NDC11Code": "55111-0112-05",
"ProductNDC": "55111-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin",
"NonProprietaryName": "Moxifloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076938",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2021-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140305",
"SamplePackage": "N",
"Description": "Moxifloxacin hydrochloride USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows."
},
{
"NDCCode": "55111-121-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-121-05) ",
"NDC11Code": "55111-0121-05",
"ProductNDC": "55111-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091650",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose."
},
{
"NDCCode": "55111-122-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-122-05) ",
"NDC11Code": "55111-0122-05",
"ProductNDC": "55111-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091650",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose."
},
{
"NDCCode": "55111-123-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-123-05) ",
"NDC11Code": "55111-0123-05",
"ProductNDC": "55111-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091650",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose."
},
{
"NDCCode": "55111-124-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-124-05) ",
"NDC11Code": "55111-0124-05",
"ProductNDC": "55111-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202357",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 80 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains lecithin, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum. Atorvastatin calcium tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-126-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-126-05) ",
"NDC11Code": "55111-0126-05",
"ProductNDC": "55111-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-127-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-127-05) ",
"NDC11Code": "55111-0127-05",
"ProductNDC": "55111-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-128-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-128-05) ",
"NDC11Code": "55111-0128-05",
"ProductNDC": "55111-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-129-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (55111-129-05) ",
"NDC11Code": "55111-0129-05",
"ProductNDC": "55111-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine Hydrochloride",
"NonProprietaryName": "Ranitidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075742",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010112",
"SamplePackage": "N",
"IndicationAndUsage": "Ranitidine is indicated in:. 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily. 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.",
"Description": "Ranitidine hydrochloride (HCl) USP, is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structural formula. The molecular formula is C13H22N4O3SHCl, representing a molecular weight of 350.87. Ranitidine hydrochloride USP is a white to pale yellow, crystalline practically odorless powder, is sensitive to light and moisture. It is very soluble in water and sparingly soluble in alcohol. Each Ranitidine Hydrochloride capsule, for oral administration, contains 167.4 mg or 334.8 mg of ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Magnesium Stearate. The capsule shells contain Black Iron Oxide, Red Iron Oxide T3469, Yellow Iron Oxide T3506, Titanium Dioxide and Gelatin. The capsule shells are imprinted with edible ink."
},
{
"NDCCode": "55111-143-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-143-05) ",
"NDC11Code": "55111-0143-05",
"ProductNDC": "55111-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-144-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-144-05) ",
"NDC11Code": "55111-0144-05",
"ProductNDC": "55111-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-146-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-146-05) ",
"NDC11Code": "55111-0146-05",
"ProductNDC": "55111-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-149-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (55111-149-05)",
"NDC11Code": "55111-0149-05",
"ProductNDC": "55111-149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075465",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55111-150-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05) ",
"NDC11Code": "55111-0150-05",
"ProductNDC": "55111-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076006",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160930",
"SamplePackage": "N",
"Description": "Fluoxetine tablets USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder, sparingly soluble in water and in dichloromethane; freely soluble in methanol, and in alcohol, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 µmol) and 20 mg (64.7 µmol) of fluoxetine. The tablet also contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. In addition, the coating for each tablet contains FD&C Blue #1 (10 mg), hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-153-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-153-05) ",
"NDC11Code": "55111-0153-05",
"ProductNDC": "55111-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-154-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-154-05) ",
"NDC11Code": "55111-0154-05",
"ProductNDC": "55111-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-155-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-155-05) ",
"NDC11Code": "55111-0155-05",
"ProductNDC": "55111-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-156-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-156-05) ",
"NDC11Code": "55111-0156-05",
"ProductNDC": "55111-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "24",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-159-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-159-05) ",
"NDC11Code": "55111-0159-05",
"ProductNDC": "55111-159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075576",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090121",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-160-05",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (55111-160-05) ",
"NDC11Code": "55111-0160-05",
"ProductNDC": "55111-160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077098",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060210",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>55111-596-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-596-05) </PackageDescription>
<NDC11Code>55111-0596-05</NDC11Code>
<ProductNDC>55111-596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>68382-596-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-596-05) </PackageDescription>
<NDC11Code>68382-0596-05</NDC11Code>
<ProductNDC>68382-596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206534</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</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>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). 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. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). Each capsule contains the following inactive ingredients: acetyl tributyl citrate, ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, colloidal silicon dioxide, gelatin, hypromellose, sodium lauryl sulfate, sugar sphere, talc and titanium dioxide. Additionally each 120 mg capsule shell contains D & C yellow # 10, FD & C blue # 1 and FD & C red # 40; each 180 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and iron oxide black; each 240 mg capsule shell contains FD & C blue # 1 and FD & C red # 3; each 300 mg capsule shell contains D & C yellow # 10, FD & C blue # 1, FD & C red # 40 and iron oxide black; each 360 mg capsule shell contains iron oxide black. 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. Diltiazem Hydrochloride Extended-release Capsule, USP meets USP Dissolution Test 3. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68428-596-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-596-05) </PackageDescription>
<NDC11Code>68428-0596-05</NDC11Code>
<ProductNDC>68428-596</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ratanhia</ProprietaryName>
<NonProprietaryName>Krameria Lappacea Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091028</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>KRAMERIA LAPPACEA ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84756-596-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-596-05) </PackageDescription>
<NDC11Code>84756-0596-05</NDC11Code>
<ProductNDC>84756-596</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dark Spot Correcting Cream</ProprietaryName>
<NonProprietaryName>Dark Spot Correcting Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84827-596-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84827-596-05) </PackageDescription>
<NDC11Code>84827-0596-05</NDC11Code>
<ProductNDC>84827-596</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Pearl Cream</ProprietaryName>
<NonProprietaryName>Trstay Pearl Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-596-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (55111-596-01) </PackageDescription>
<NDC11Code>55111-0596-01</NDC11Code>
<ProductNDC>55111-596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>55111-596-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (55111-596-30) </PackageDescription>
<NDC11Code>55111-0596-30</NDC11Code>
<ProductNDC>55111-596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>55111-596-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55111-596-60) </PackageDescription>
<NDC11Code>55111-0596-60</NDC11Code>
<ProductNDC>55111-596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>55111-596-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-596-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55111-0596-78</NDC11Code>
<ProductNDC>55111-596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>55111-596-79</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (55111-596-79) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55111-0596-79</NDC11Code>
<ProductNDC>55111-596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>55111-112-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-112-05) </PackageDescription>
<NDC11Code>55111-0112-05</NDC11Code>
<ProductNDC>55111-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin</ProprietaryName>
<NonProprietaryName>Moxifloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076938</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Moxifloxacin hydrochloride USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>55111-121-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-121-05) </PackageDescription>
<NDC11Code>55111-0121-05</NDC11Code>
<ProductNDC>55111-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091650</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>55111-122-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-122-05) </PackageDescription>
<NDC11Code>55111-0122-05</NDC11Code>
<ProductNDC>55111-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091650</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>55111-123-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-123-05) </PackageDescription>
<NDC11Code>55111-0123-05</NDC11Code>
<ProductNDC>55111-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091650</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>55111-124-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-124-05) </PackageDescription>
<NDC11Code>55111-0124-05</NDC11Code>
<ProductNDC>55111-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202357</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 80 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains lecithin, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum. Atorvastatin calcium tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-126-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-126-05) </PackageDescription>
<NDC11Code>55111-0126-05</NDC11Code>
<ProductNDC>55111-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-127-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-127-05) </PackageDescription>
<NDC11Code>55111-0127-05</NDC11Code>
<ProductNDC>55111-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-128-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-128-05) </PackageDescription>
<NDC11Code>55111-0128-05</NDC11Code>
<ProductNDC>55111-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-129-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (55111-129-05) </PackageDescription>
<NDC11Code>55111-0129-05</NDC11Code>
<ProductNDC>55111-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075742</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranitidine is indicated in:. 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily. 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.</IndicationAndUsage>
<Description>Ranitidine hydrochloride (HCl) USP, is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structural formula. The molecular formula is C13H22N4O3SHCl, representing a molecular weight of 350.87. Ranitidine hydrochloride USP is a white to pale yellow, crystalline practically odorless powder, is sensitive to light and moisture. It is very soluble in water and sparingly soluble in alcohol. Each Ranitidine Hydrochloride capsule, for oral administration, contains 167.4 mg or 334.8 mg of ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Magnesium Stearate. The capsule shells contain Black Iron Oxide, Red Iron Oxide T3469, Yellow Iron Oxide T3506, Titanium Dioxide and Gelatin. The capsule shells are imprinted with edible ink.</Description>
</NDC>
<NDC>
<NDCCode>55111-143-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-143-05) </PackageDescription>
<NDC11Code>55111-0143-05</NDC11Code>
<ProductNDC>55111-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-144-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-144-05) </PackageDescription>
<NDC11Code>55111-0144-05</NDC11Code>
<ProductNDC>55111-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-146-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-146-05) </PackageDescription>
<NDC11Code>55111-0146-05</NDC11Code>
<ProductNDC>55111-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-149-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (55111-149-05)</PackageDescription>
<NDC11Code>55111-0149-05</NDC11Code>
<ProductNDC>55111-149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075465</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55111-150-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05) </PackageDescription>
<NDC11Code>55111-0150-05</NDC11Code>
<ProductNDC>55111-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076006</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fluoxetine tablets USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder, sparingly soluble in water and in dichloromethane; freely soluble in methanol, and in alcohol, practically insoluble in ether. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 µmol) and 20 mg (64.7 µmol) of fluoxetine. The tablet also contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. In addition, the coating for each tablet contains FD&C Blue #1 (10 mg), hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-153-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-153-05) </PackageDescription>
<NDC11Code>55111-0153-05</NDC11Code>
<ProductNDC>55111-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-154-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-154-05) </PackageDescription>
<NDC11Code>55111-0154-05</NDC11Code>
<ProductNDC>55111-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-155-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-155-05) </PackageDescription>
<NDC11Code>55111-0155-05</NDC11Code>
<ProductNDC>55111-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-156-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-156-05) </PackageDescription>
<NDC11Code>55111-0156-05</NDC11Code>
<ProductNDC>55111-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-159-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-159-05) </PackageDescription>
<NDC11Code>55111-0159-05</NDC11Code>
<ProductNDC>55111-159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075576</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-160-05</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE (55111-160-05) </PackageDescription>
<NDC11Code>55111-0160-05</NDC11Code>
<ProductNDC>55111-160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077098</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>