RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "69097-392-20",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (69097-392-20)  > 10 TABLET, COATED in 1 BLISTER PACK (69097-392-19) ",
      "NDC11Code": "69097-0392-20",
      "ProductNDC": "69097-392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Deferasirox",
      "NonProprietaryName": "Deferasirox",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211852",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "DEFERASIROX",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Deferasirox tablet is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox tablet is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
      "Description": "Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer (188), povidone (K30) and purified water. The film coating contains hypromellose, iron oxide red, macrogol, talc and titanium dioxide."
    },
    {
      "NDCCode": "69097-392-02",
      "PackageDescription": "30 TABLET, COATED in 1 BOTTLE (69097-392-02) ",
      "NDC11Code": "69097-0392-02",
      "ProductNDC": "69097-392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Deferasirox",
      "NonProprietaryName": "Deferasirox",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200614",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211852",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "DEFERASIROX",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Deferasirox tablet is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox tablet is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
      "Description": "Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer (188), povidone (K30) and purified water. The film coating contains hypromellose, iron oxide red, macrogol, talc and titanium dioxide."
    },
    {
      "NDCCode": "69097-287-81",
      "PackageDescription": "20 TABLET in 1 BOTTLE (69097-287-81) ",
      "NDC11Code": "69097-0287-81",
      "ProductNDC": "69097-287",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120330",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076890",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20120330",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69097-353-78",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (69097-353-78)  > 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "69097-0353-78",
      "ProductNDC": "69097-353",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxaliplatin",
      "NonProprietaryName": "Oxaliplatin",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208523",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "OXALIPLATIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170210",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69097-391-20",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (69097-391-20)  > 10 TABLET, COATED in 1 BLISTER PACK (69097-391-19) ",
      "NDC11Code": "69097-0391-20",
      "ProductNDC": "69097-391",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Deferasirox",
      "NonProprietaryName": "Deferasirox",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211852",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "DEFERASIROX",
      "StrengthNumber": "90",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Deferasirox tablet is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox tablet is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
      "Description": "Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer (188), povidone (K30) and purified water. The film coating contains hypromellose, iron oxide red, macrogol, talc and titanium dioxide."
    },
    {
      "NDCCode": "69097-393-20",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (69097-393-20)  > 10 TABLET, COATED in 1 BLISTER PACK (69097-393-19) ",
      "NDC11Code": "69097-0393-20",
      "ProductNDC": "69097-393",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Deferasirox",
      "NonProprietaryName": "Deferasirox",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211852",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "DEFERASIROX",
      "StrengthNumber": "360",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Deferasirox tablet is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox tablet is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
      "Description": "Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula. Deferasirox is a white to slightly yellow powder. It has a molecular formula C21H15N3O4 and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1. Deferasirox tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer (188), povidone (K30) and purified water. The film coating contains hypromellose, iron oxide red, macrogol, talc and titanium dioxide."
    },
    {
      "NDCCode": "69097-398-78",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78)  / 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "69097-0398-78",
      "ProductNDC": "69097-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paclitaxel Protein-bound Particles",
      "NonProprietaryName": "Paclitaxel Protein-bound Particles",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250415",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209657",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "PACLITAXEL",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250415",
      "SamplePackage": "N",
      "IndicationAndUsage": "Paclitaxel is a microtubule inhibitor indicated for the treatment of: 1 Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (1.1), 2 Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. (1.2), 3 Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. (1.3).",
      "Description": "Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non‑crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy- 1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. The empirical formula is C47H51NO14 and the molecular weight is 853.93. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at approximately 206°C to 215°C. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized  cake or powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-dose vial contains 100 mg of paclitaxel, USP (semi-synthetic) (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin-bound particles. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is free of solvents."
    },
    {
      "NDCCode": "33342-392-05",
      "PackageDescription": "20 TABLET in 1 BOTTLE (33342-392-05) ",
      "NDC11Code": "33342-0392-05",
      "ProductNDC": "33342-392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211418",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251119",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections:  Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.  Respiratory tract infections caused by Mycoplasma pneumoniae.  Lymphogranuloma venereum caused by Chlamydia trachomatis.  Psittacosis (ornithosis) caused by Chlamydophila psittaci.  Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.  Inclusion conjunctivitis caused by Chlamydia trachomatis.  Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.  Nongonococcal urethritis caused by Ureaplasma urealyticum.  Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.  Chancroid caused by Haemophilus ducreyi.  Plague due to Yersinia pestis.  Tularemia due to Francisella tularensis.  Cholera caused by Vibrio cholerae.  Campylobacter fetus infections caused by Campylobacter fetus.  Brucellosis due to Brucella species (in conjunction with streptomycin).  Bartonellosis due to Bartonella bacilliformis.  Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:.  Escherichia coli.  Enterobacter aerogenes. Shigella species.  Acinetobacter species.  Respiratory tract infections caused by Haemophilus influenzae.  Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:.  Upper respiratory infections caused by Streptococcus pneumoniae.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.  Yaws caused by Treponema pallidum subspecies pertenue.  Listeriosis due to Listeria monocytogenes.  Vincent’s infection caused by Fusobacterium fusiforme.  Actinomycosis caused by Actinomyces israelii.  Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas withchloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).",
      "Description": "Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8 . HCl)2 . C2H6O . H2O and the molecular weight is 1025.89. The chemical designation for doxycycline hyclate is  4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline Hyclate light-yellowish crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the tablet formulations are: microcrystalline cellulose colloidal silicon dioxide, croscarmellose sodium, pregelatinized Starch, Sodium Stearyl fumarate, and magnesium stearate, The coating material contain, Hypromellose, Polyethylene Glycol 400, titanium dioxide, and FD and C Yellow No. 6 Al. Lake."
    },
    {
      "NDCCode": "37808-392-20",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (37808-392-20) ",
      "NDC11Code": "37808-0392-20",
      "ProductNDC": "37808-392",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Fexofenadine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211075",
      "LabelerName": "HEB",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220531",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "46122-392-60",
      "PackageDescription": "20 PATCH in 1 BOX (46122-392-60)  / 9 g in 1 PATCH",
      "NDC11Code": "46122-0392-60",
      "ProductNDC": "46122-392",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pain Relief Patches",
      "NonProprietaryName": "Camphor, Menthol, Methyl Salicylate",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE",
      "StrengthNumber": "3.1; 6; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180101",
      "EndMarketingDatePackage": "20261210",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of minor aches and pains."
    },
    {
      "NDCCode": "47682-392-71",
      "PackageDescription": "20 PACKET in 1 BOX (47682-392-71)  > .5 g in 1 PACKET",
      "NDC11Code": "47682-0392-71",
      "ProductNDC": "47682-392",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triple Antibiotic",
      "NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130412",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333B",
      "LabelerName": "Unifirst First Aid Corporation",
      "SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
      "StrengthNumber": "400; 3.5; 5000",
      "StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20130412",
      "EndMarketingDatePackage": "20190701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51079-392-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-392-20)  > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-392-01) ",
      "NDC11Code": "51079-0392-20",
      "ProductNDC": "51079-392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100528",
      "EndMarketingDate": "20191031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090325",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100528",
      "EndMarketingDatePackage": "20191031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55150-392-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-392-01)  / 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "55150-0392-01",
      "ProductNDC": "55150-392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bendamustine Hydrochloride",
      "NonProprietaryName": "Bendamustine Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230605",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214739",
      "LabelerName": "Eugia US LLC",
      "SubstanceName": "BENDAMUSTINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230605",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bendamustine hydrochloride for injection is an alkylating drug indicated for treatment of patients with: 1 Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. (1.1), 2 Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (1.2).",
      "Description": "Bendamustine hydrochloride, USP is an alkylating agent. The chemical name of bendamustine hydrochloride, USP is 4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid hydrochloride monohydrate. Its molecular formula is C16H21Cl2N3O2.HCl.H2O and the molecular weight is 412.74. Bendamustine hydrochloride, USP contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent, and has the following structural formula: Bendamustine hydrochloride for injection, USP (25 mg/vial or 100 mg/vial lyophilized powder) Bendamustine hydrochloride for injection, USP for intravenous use is supplied as a sterile non-pyrogenic white to off-white lyophilized powder in a single-dose vial. Each 25 mg vial contains 25 mg of bendamustine hydrochloride, USP and 42.5 mg of mannitol, USP. Each 100 mg vial contains 100 mg of bendamustine hydrochloride, USP and 170 mg of mannitol, USP. The pH of the reconstituted solution is 2.5 to 3.5."
    },
    {
      "NDCCode": "71610-392-20",
      "PackageDescription": "20 TABLET, COATED in 1 BOTTLE (71610-392-20) ",
      "NDC11Code": "71610-0392-20",
      "ProductNDC": "71610-392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076003",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .",
      "Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "76420-392-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (76420-392-20) ",
      "NDC11Code": "76420-0392-20",
      "ProductNDC": "76420-392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205129",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250620",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib is indicated.",
      "Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 200 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below.  200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide."
    },
    {
      "NDCCode": "69097-004-67",
      "PackageDescription": "1 VIAL in 1 CARTON (69097-004-67)  / 2 mL in 1 VIAL",
      "NDC11Code": "69097-0004-67",
      "ProductNDC": "69097-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone Sodium Succinate",
      "NonProprietaryName": "Hydrocortisone Sodium Succinate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20240925",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214050",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-09-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240925",
      "SamplePackage": "N",
      "IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of hydrocortisone sodium succinate for injection is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
      "Description": "Hydrocortisone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate, USP as the active ingredient. Hydrocortisone sodium succinate for injection, USP is available in below mentioned package for intravenous or intramuscular administration. 100 mg Plain—Vials containing hydrocortisone sodium succinate, USP equivalent to 100 mg hydrocortisone, 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. Hydrocortisone sodium succinate for injection, USP 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION, Preparation of Solutions). When necessary, the pH was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8. The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52. The structural formula is represented below. Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone, and insoluble in chloroform."
    },
    {
      "NDCCode": "69097-143-02",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-143-02) ",
      "NDC11Code": "69097-0143-02",
      "ProductNDC": "69097-143",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "2.5; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-143-06",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-143-06) ",
      "NDC11Code": "69097-0143-06",
      "ProductNDC": "69097-143",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "2.5; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-143-12",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (69097-143-12) ",
      "NDC11Code": "69097-0143-12",
      "ProductNDC": "69097-143",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "2.5; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-144-02",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-144-02) ",
      "NDC11Code": "69097-0144-02",
      "ProductNDC": "69097-144",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "5; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-144-06",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-144-06) ",
      "NDC11Code": "69097-0144-06",
      "ProductNDC": "69097-144",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "5; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-144-12",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (69097-144-12) ",
      "NDC11Code": "69097-0144-12",
      "ProductNDC": "69097-144",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "5; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-145-02",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-145-02) ",
      "NDC11Code": "69097-0145-02",
      "ProductNDC": "69097-145",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-145-06",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-145-06) ",
      "NDC11Code": "69097-0145-06",
      "ProductNDC": "69097-145",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-145-12",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (69097-145-12) ",
      "NDC11Code": "69097-0145-12",
      "ProductNDC": "69097-145",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "5; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-146-02",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-146-02) ",
      "NDC11Code": "69097-0146-02",
      "ProductNDC": "69097-146",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "10; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-146-06",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (69097-146-06) ",
      "NDC11Code": "69097-0146-06",
      "ProductNDC": "69097-146",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "10; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-146-12",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (69097-146-12) ",
      "NDC11Code": "69097-0146-12",
      "ProductNDC": "69097-146",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077215",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
      "StrengthNumber": "10; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and benazepril hydrochloride is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
      "Description": "Amlodipine and benazepril hydrochloride capsules, USP is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl 3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its molecular formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules, USP are formulated in four different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg. The inactive ingredients of the capsules are colloidal silicon dioxide, crospovidone, dibasic calcium phosphate dihydrate, gelatin, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, siliconized talc, and titanium dioxide. The 2.5 mg/10 mg capsules also contain D&C Yellow #10. The 5 mg/10 mg capsules also contain D&C Yellow #10 and FD&C Yellow #6. The 5 mg/20 mg and 10 mg/20 mg capsules also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40."
    },
    {
      "NDCCode": "69097-183-05",
      "PackageDescription": "90 TABLET in 1 BOTTLE (69097-183-05) ",
      "NDC11Code": "69097-0183-05",
      "ProductNDC": "69097-183",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pravastatin Sodium",
      "NonProprietaryName": "Pravastatin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077904",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "PRAVASTATIN SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20061023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: : 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1), 2 Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. (1.1), 3 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2), 4 Reduce elevated serum TG levels in patients with hypertriglyceridemia.(1.2), 5 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 6 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).",
      "Description": "Pravastatin sodium tablets, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Calcium Stearate, Crospovidone, Ferric Oxide, Low Substituted Hydroxypropyl Cellulose and Mannitol."
    },
    {
      "NDCCode": "69097-183-12",
      "PackageDescription": "500 TABLET in 1 BOTTLE (69097-183-12) ",
      "NDC11Code": "69097-0183-12",
      "ProductNDC": "69097-183",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pravastatin Sodium",
      "NonProprietaryName": "Pravastatin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077904",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "PRAVASTATIN SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20061023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: : 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1), 2 Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. (1.1), 3 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2), 4 Reduce elevated serum TG levels in patients with hypertriglyceridemia.(1.2), 5 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 6 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).",
      "Description": "Pravastatin sodium tablets, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: Calcium Stearate, Crospovidone, Ferric Oxide, Low Substituted Hydroxypropyl Cellulose and Mannitol."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"69097-392-20","ProprietaryName":"Deferasirox","NonProprietaryName":"Deferasirox"},{"NDCCode":"69097-392-02","ProprietaryName":"Deferasirox","NonProprietaryName":"Deferasirox"},{"NDCCode":"69097-287-81","ProprietaryName":"Levofloxacin","NonProprietaryName":"Levofloxacin"},{"NDCCode":"69097-353-78","ProprietaryName":"Oxaliplatin","NonProprietaryName":"Oxaliplatin"},{"NDCCode":"69097-391-20","ProprietaryName":"Deferasirox","NonProprietaryName":"Deferasirox"},{"NDCCode":"69097-393-20","ProprietaryName":"Deferasirox","NonProprietaryName":"Deferasirox"},{"NDCCode":"69097-398-78","ProprietaryName":"Paclitaxel Protein-bound Particles","NonProprietaryName":"Paclitaxel Protein-bound Particles"},{"NDCCode":"33342-392-05","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"37808-392-20","ProprietaryName":"Allergy Relief","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"46122-392-60","ProprietaryName":"Pain Relief Patches","NonProprietaryName":"Camphor, Menthol, Methyl Salicylate"},{"NDCCode":"47682-392-71","ProprietaryName":"Triple Antibiotic","NonProprietaryName":"Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate"},{"NDCCode":"51079-392-20","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"55150-392-01","ProprietaryName":"Bendamustine Hydrochloride","NonProprietaryName":"Bendamustine Hydrochloride"},{"NDCCode":"71610-392-20","ProprietaryName":"Tramadol Hydrochloride","NonProprietaryName":"Tramadol Hydrochloride"},{"NDCCode":"76420-392-20","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"},{"NDCCode":"69097-004-67","ProprietaryName":"Hydrocortisone Sodium Succinate","NonProprietaryName":"Hydrocortisone Sodium Succinate"},{"NDCCode":"69097-143-02","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-143-06","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-143-12","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-144-02","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-144-06","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-144-12","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-145-02","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-145-06","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-145-12","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-146-02","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-146-06","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-146-12","ProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride","NonProprietaryName":"Amlodipine Besylate And Benazepril Hydrochloride"},{"NDCCode":"69097-183-05","ProprietaryName":"Pravastatin Sodium","NonProprietaryName":"Pravastatin Sodium"},{"NDCCode":"69097-183-12","ProprietaryName":"Pravastatin Sodium","NonProprietaryName":"Pravastatin Sodium"}]}
                    

<NDCList><NDC><NDCCode>69097-392-20</NDCCode><ProprietaryName>Deferasirox</ProprietaryName><NonProprietaryName>Deferasirox</NonProprietaryName></NDC><NDC><NDCCode>69097-392-02</NDCCode><ProprietaryName>Deferasirox</ProprietaryName><NonProprietaryName>Deferasirox</NonProprietaryName></NDC><NDC><NDCCode>69097-287-81</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>69097-353-78</NDCCode><ProprietaryName>Oxaliplatin</ProprietaryName><NonProprietaryName>Oxaliplatin</NonProprietaryName></NDC><NDC><NDCCode>69097-391-20</NDCCode><ProprietaryName>Deferasirox</ProprietaryName><NonProprietaryName>Deferasirox</NonProprietaryName></NDC><NDC><NDCCode>69097-393-20</NDCCode><ProprietaryName>Deferasirox</ProprietaryName><NonProprietaryName>Deferasirox</NonProprietaryName></NDC><NDC><NDCCode>69097-398-78</NDCCode><ProprietaryName>Paclitaxel Protein-bound Particles</ProprietaryName><NonProprietaryName>Paclitaxel Protein-bound Particles</NonProprietaryName></NDC><NDC><NDCCode>33342-392-05</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>37808-392-20</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>46122-392-60</NDCCode><ProprietaryName>Pain Relief Patches</ProprietaryName><NonProprietaryName>Camphor, Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>47682-392-71</NDCCode><ProprietaryName>Triple Antibiotic</ProprietaryName><NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate</NonProprietaryName></NDC><NDC><NDCCode>51079-392-20</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55150-392-01</NDCCode><ProprietaryName>Bendamustine Hydrochloride</ProprietaryName><NonProprietaryName>Bendamustine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71610-392-20</NDCCode><ProprietaryName>Tramadol Hydrochloride</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76420-392-20</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>69097-004-67</NDCCode><ProprietaryName>Hydrocortisone Sodium Succinate</ProprietaryName><NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName></NDC><NDC><NDCCode>69097-143-02</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-143-06</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-143-12</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-144-02</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-144-06</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-144-12</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-145-02</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-145-06</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-145-12</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-146-02</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-146-06</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-146-12</NDCCode><ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69097-183-05</NDCCode><ProprietaryName>Pravastatin Sodium</ProprietaryName><NonProprietaryName>Pravastatin Sodium</NonProprietaryName></NDC><NDC><NDCCode>69097-183-12</NDCCode><ProprietaryName>Pravastatin Sodium</ProprietaryName><NonProprietaryName>Pravastatin Sodium</NonProprietaryName></NDC></NDCList>