{
"NDC": [
{
"NDCCode": "55111-282-05",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (55111-282-05) ",
"NDC11Code": "55111-0282-05",
"ProductNDC": "55111-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090392",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110224",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-282-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (55111-282-01) ",
"NDC11Code": "55111-0282-01",
"ProductNDC": "55111-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090392",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110224",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-282-18",
"PackageDescription": "180 TABLET, COATED in 1 BOTTLE (55111-282-18) ",
"NDC11Code": "55111-0282-18",
"ProductNDC": "55111-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090392",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110224",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-282-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (55111-282-30) ",
"NDC11Code": "55111-0282-30",
"ProductNDC": "55111-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090392",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110224",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-282-60",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE (55111-282-60) ",
"NDC11Code": "55111-0282-60",
"ProductNDC": "55111-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090392",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110224",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-282-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-282-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79) ",
"NDC11Code": "55111-0282-78",
"ProductNDC": "55111-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090392",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110224",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55111-282-90",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (55111-282-90) ",
"NDC11Code": "55111-0282-90",
"ProductNDC": "55111-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090392",
"LabelerName": "Dr.Reddy's laboratories Ltd.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110224",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "13107-282-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05) ",
"NDC11Code": "13107-0282-05",
"ProductNDC": "13107-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorazepate Dipotassium",
"NonProprietaryName": "Clorazepate Dipotassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071858",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "CLORAZEPATE DIPOTASSIUM",
"StrengthNumber": "3.75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230923",
"SamplePackage": "N",
"IndicationAndUsage": "Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.",
"Description": "Chemically, clorazepate dipotassium is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows. The compound occurs as a fine, white or light yellow crystalline powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate dipotassium tablets, USP contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP for oral administration. Inactive ingredients for clorazepate dipotassium tablets: croscarmellose sodium, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, sodium chloride and sodium lauryl sulfate. The 3.75 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and the 7.5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake."
},
{
"NDCCode": "31722-282-05",
"PackageDescription": "24 BOTTLE in 1 CASE (31722-282-05) > 500 TABLET in 1 BOTTLE",
"NDC11Code": "31722-0282-05",
"ProductNDC": "31722-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "50383-282-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50383-282-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50383-0282-05",
"ProductNDC": "50383-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC; TOPICAL",
"StartMarketingDate": "20050121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076673",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59137-282-05",
"PackageDescription": "1 KIT in 1 CARTON (59137-282-05) * 5 mL in 1 VIAL (59137-270-01) * 5 mL in 1 SYRINGE (59137-280-01) ",
"NDC11Code": "59137-0282-05",
"ProductNDC": "59137-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ixinity",
"NonProprietaryName": "Coagulation Factor Ix (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20170512",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125426",
"LabelerName": "Medexus Pharma, Inc.",
"Status": "Active",
"LastUpdate": "2024-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "IXINITY [coagulation factor IX (recombinant)] is a purified protein that has 415 amino acids. It has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. Coagulation factor IX (recombinant) is a single-chain glycoprotein with a molecular mass of about 55,000 Dalton that is secreted by a genetically engineered mammalian cell line derived from Chinese hamster ovary (CHO) cells. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain hormones. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal, namely, solvent/detergent treatment, a chromatographic step, and nanofiltration. The process also includes a validated step to reduce the presence of CHO proteins in the final drug product. IXINITY is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-dose vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are."
},
{
"NDCCode": "68428-282-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-282-05) ",
"NDC11Code": "68428-0282-05",
"ProductNDC": "68428-282",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camphora",
"NonProprietaryName": "Camphor (natural)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CAMPHOR (NATURAL)",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "72865-282-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (72865-282-05) ",
"NDC11Code": "72865-0282-05",
"ProductNDC": "72865-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214730",
"LabelerName": "XLCare Pharmaceuticals, Inc",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250226",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is 5-[(2R)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenzenesulfonamide Hydrochloride. Tamsulosin hydrochloride is a white or almost white powder, melts with decomposition at approximately 230°C. It is freely soluble in formic acid, sparingly soluble in methanol, slightly soluble in water and in dehydrated alcohol and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C20H28N2O5S·HCl. The molecular weight of tamsulosin hydrochloride is 444.97. Its structural formula is. Each tamsulosin hydrochloride capsules for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: sugar spheres (corn starch and sucrose), methacrylic acid and ethyl acrylate copolymer, ethylcellulose, polyethylene glycol, talc, methacrylic acid and ethyl acrylate copolymer dispersion, hypromellose, colloidal silicon dioxide, gelatin, sodium lauryl sulphate and titanium dioxide. The capsules are printed with Black Ink TEK SW 9008 containing black iron oxide, potassium hydroxide, propylene glycol and shellac. FDA approved dissolution specifications differ from USP."
},
{
"NDCCode": "73377-282-05",
"PackageDescription": "16400 g in 1 JAR (73377-282-05) ",
"NDC11Code": "73377-0282-05",
"ProductNDC": "73377-282",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240816",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-05-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20-MAY-25"
},
{
"NDCCode": "80777-282-99",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (80777-282-99) / 2.5 mL in 1 VIAL, MULTI-DOSE (80777-282-05) ",
"NDC11Code": "80777-0282-99",
"ProductNDC": "80777-282",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Moderna Covid-19 Vaccine, Bivalent",
"NonProprietaryName": "Moderna Covid-19 Vaccine, Bivalent",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20220728",
"MarketingCategoryName": "EMERGENCY USE AUTHORIZATION",
"LabelerName": "Moderna US, Inc.",
"SubstanceName": "CX-034476 OMICRON (BA.4/BA.5); ELASOMERAN",
"StrengthNumber": "25; 25",
"StrengthUnit": "ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220728",
"SamplePackage": "N"
},
{
"NDCCode": "83324-282-05",
"PackageDescription": "1 KIT in 1 KIT (83324-282-05) * 1 BOTTLE, DISPENSING in 1 BOX (83324-283-05) / 15 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "83324-0282-05",
"ProductNDC": "83324-282",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice Earwax Removal Kit Earwax Removal Aid And Bulb",
"NonProprietaryName": "Carbamide Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "Chain Drug Marketing Association, Inc.",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "for occasional use as an aid to soften, loosen, and remove excessive earwax."
},
{
"NDCCode": "84756-282-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-282-05) ",
"NDC11Code": "84756-0282-05",
"ProductNDC": "84756-282",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rosemary Essential Oil",
"NonProprietaryName": "Rosemary Essential Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"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": "55111-112-05",
"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",
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"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",
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"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",
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"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",
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"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"
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<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
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<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
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<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
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<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
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<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
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<NDC>
<NDCCode>55111-282-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-282-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79) </PackageDescription>
<NDC11Code>55111-0282-78</NDC11Code>
<ProductNDC>55111-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090392</ApplicationNumber>
<LabelerName>Dr.Reddy's laboratories Ltd.</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).</IndicationAndUsage>
<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-282-90</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (55111-282-90) </PackageDescription>
<NDC11Code>55111-0282-90</NDC11Code>
<ProductNDC>55111-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090392</ApplicationNumber>
<LabelerName>Dr.Reddy's laboratories Ltd.</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) , 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3).</IndicationAndUsage>
<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets is an orally active H1- receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Levocetirizine dihydrochloride white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white, oval, film coated biconvex tablets with breakline on both sides and debossed with 'R' &'5' separated by breakline on one side for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13107-282-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05) </PackageDescription>
<NDC11Code>13107-0282-05</NDC11Code>
<ProductNDC>13107-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorazepate Dipotassium</ProprietaryName>
<NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071858</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
<StrengthNumber>3.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.</IndicationAndUsage>
<Description>Chemically, clorazepate dipotassium is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows. The compound occurs as a fine, white or light yellow crystalline powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate dipotassium tablets, USP contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP for oral administration. Inactive ingredients for clorazepate dipotassium tablets: croscarmellose sodium, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, sodium chloride and sodium lauryl sulfate. The 3.75 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and the 7.5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>31722-282-05</NDCCode>
<PackageDescription>24 BOTTLE in 1 CASE (31722-282-05) > 500 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0282-05</NDC11Code>
<ProductNDC>31722-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>50383-282-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (50383-282-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50383-0282-05</NDC11Code>
<ProductNDC>50383-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC; TOPICAL</RouteName>
<StartMarketingDate>20050121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076673</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59137-282-05</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59137-282-05) * 5 mL in 1 VIAL (59137-270-01) * 5 mL in 1 SYRINGE (59137-280-01) </PackageDescription>
<NDC11Code>59137-0282-05</NDC11Code>
<ProductNDC>59137-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ixinity</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170512</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125426</ApplicationNumber>
<LabelerName>Medexus Pharma, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>IXINITY [coagulation factor IX (recombinant)] is a purified protein that has 415 amino acids. It has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. Coagulation factor IX (recombinant) is a single-chain glycoprotein with a molecular mass of about 55,000 Dalton that is secreted by a genetically engineered mammalian cell line derived from Chinese hamster ovary (CHO) cells. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain hormones. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal, namely, solvent/detergent treatment, a chromatographic step, and nanofiltration. The process also includes a validated step to reduce the presence of CHO proteins in the final drug product. IXINITY is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-dose vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are.</Description>
</NDC>
<NDC>
<NDCCode>68428-282-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-282-05) </PackageDescription>
<NDC11Code>68428-0282-05</NDC11Code>
<ProductNDC>68428-282</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camphora</ProprietaryName>
<NonProprietaryName>Camphor (natural)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CAMPHOR (NATURAL)</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72865-282-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (72865-282-05) </PackageDescription>
<NDC11Code>72865-0282-05</NDC11Code>
<ProductNDC>72865-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214730</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is 5-[(2R)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenzenesulfonamide Hydrochloride. Tamsulosin hydrochloride is a white or almost white powder, melts with decomposition at approximately 230°C. It is freely soluble in formic acid, sparingly soluble in methanol, slightly soluble in water and in dehydrated alcohol and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C20H28N2O5S·HCl. The molecular weight of tamsulosin hydrochloride is 444.97. Its structural formula is. Each tamsulosin hydrochloride capsules for oral administration contains tamsulosin hydrochloride, USP 0.4 mg, and the following inactive ingredients: sugar spheres (corn starch and sucrose), methacrylic acid and ethyl acrylate copolymer, ethylcellulose, polyethylene glycol, talc, methacrylic acid and ethyl acrylate copolymer dispersion, hypromellose, colloidal silicon dioxide, gelatin, sodium lauryl sulphate and titanium dioxide. The capsules are printed with Black Ink TEK SW 9008 containing black iron oxide, potassium hydroxide, propylene glycol and shellac. FDA approved dissolution specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>73377-282-05</NDCCode>
<PackageDescription>16400 g in 1 JAR (73377-282-05) </PackageDescription>
<NDC11Code>73377-0282-05</NDC11Code>
<ProductNDC>73377-282</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240816</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-MAY-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>80777-282-99</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (80777-282-99) / 2.5 mL in 1 VIAL, MULTI-DOSE (80777-282-05) </PackageDescription>
<NDC11Code>80777-0282-99</NDC11Code>
<ProductNDC>80777-282</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Moderna Covid-19 Vaccine, Bivalent</ProprietaryName>
<NonProprietaryName>Moderna Covid-19 Vaccine, Bivalent</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220728</StartMarketingDate>
<MarketingCategoryName>EMERGENCY USE AUTHORIZATION</MarketingCategoryName>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-034476 OMICRON (BA.4/BA.5); ELASOMERAN</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83324-282-05</NDCCode>
<PackageDescription>1 KIT in 1 KIT (83324-282-05) * 1 BOTTLE, DISPENSING in 1 BOX (83324-283-05) / 15 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>83324-0282-05</NDC11Code>
<ProductNDC>83324-282</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice Earwax Removal Kit Earwax Removal Aid And Bulb</ProprietaryName>
<NonProprietaryName>Carbamide Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for occasional use as an aid to soften, loosen, and remove excessive earwax.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-282-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84756-282-05) </PackageDescription>
<NDC11Code>84756-0282-05</NDC11Code>
<ProductNDC>84756-282</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rosemary Essential Oil</ProprietaryName>
<NonProprietaryName>Rosemary Essential Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Luoxin E� Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</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>55111-112-05</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>
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<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>
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<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>
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<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>
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