RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "63323-139-40",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-139-40)  / 40 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0139-40",
      "ProductNDC": "63323-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20000906",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "146",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000906",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.  Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.",
      "Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes.  The preparation contains 2.5 mEq/mL (14.6%) sodium chloride, in Water for Injection.  The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0.  Each mL contains: Sodium chloride 146 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid.  The osmolar concentration of the 2.5 mEq/mL solution is 5 mOsmol/mL.  Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water."
    },
    {
      "NDCCode": "63323-090-40",
      "PackageDescription": "25 VIAL, PLASTIC in 1 TRAY (63323-090-40)  > 40 mL in 1 VIAL, PLASTIC (63323-090-04) ",
      "NDC11Code": "63323-0090-40",
      "ProductNDC": "63323-090",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210428",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212070",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "meq/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-05-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210428",
      "SamplePackage": "N",
      "IndicationAndUsage": "14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.",
      "Description": "14.6% Sodium Chloride Injection, USP Additive Solution is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparations contain either 2.92 or 5.84 g of sodium chloride (50 or 100 mEq each of Na+ and Cl-) in Water for Injection, USP. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH 4.8 (4.5 to 7.0). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 5 mOsmol/mL (calc.); specific gravity is 1.10. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
    },
    {
      "NDCCode": "63323-622-00",
      "PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (63323-622-00)  / 40 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "63323-0622-00",
      "ProductNDC": "63323-622",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pemetrexed",
      "NonProprietaryName": "Pemetrexed Disodium",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090384",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PEMETREXED DISODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "g/40mL",
      "Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220525",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: : 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1) , 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1) , 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1) , 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1) Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1) , 5 initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2) .",
      "Description": "Pemetrexed for Injection, USP is a folate analog metabolic inhibitor. Pemetrexed disodium, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt. The structural formula is as follows:. Pemetrexed for Injection, USP is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100 mg, 500 mg, 750 mg or 1 g vial of Pemetrexed for Injection, USP contains pemetrexed disodium equivalent to 100 mg pemetrexed and 106 mg mannitol, 500 mg pemetrexed and 500 mg mannitol, 750 mg pemetrexed and 750 mg mannitol or 1 g pemetrexed and 1 g mannitol, respectively. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH."
    },
    {
      "NDCCode": "63323-632-40",
      "PackageDescription": "10 BAG in 1 CASE (63323-632-40)  > 1000 mL in 1 BAG (63323-632-10) ",
      "NDC11Code": "63323-0632-40",
      "ProductNDC": "63323-632",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170919",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207310",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-02-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170919",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
      "Description": "0.9% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for injection, USP is chemically designated H2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
    },
    {
      "NDCCode": "49404-139-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (49404-139-02)  / 40 mL in 1 CONTAINER",
      "NDC11Code": "49404-0139-02",
      "ProductNDC": "49404-139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr.jart Black Label Detox Beauty Balm",
      "NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180502",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Have & Be Co., Ltd.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "2.4; .8; 3.328; .784",
      "StrengthUnit": "mg/40mL; mg/40mL; mg/40mL; mg/40mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190618",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51769-139-40",
      "PackageDescription": "400 mL in 1 BOTTLE, PLASTIC (51769-139-40)",
      "NDC11Code": "51769-0139-40",
      "ProductNDC": "51769-139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders",
      "ProprietaryNameSuffix": "Renewing Clean",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130129",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "ALL NATURAL DYNAMICS",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": ".01",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
    },
    {
      "NDCCode": "54838-139-40",
      "PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (54838-139-40) ",
      "NDC11Code": "54838-0139-40",
      "ProductNDC": "54838-139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diabetic Siltussin Dm Das-na",
      "NonProprietaryName": "Guaifenesin And Dextromethorphan Hydrobromide",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051105",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
      "StrengthNumber": "10; 100",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-07-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20051105",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55289-139-40",
      "PackageDescription": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-139-40)",
      "NDC11Code": "55289-0139-40",
      "ProductNDC": "55289-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Hydrochloride",
      "NonProprietaryName": "Hydroxyzine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088618",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-04-04"
    },
    {
      "NDCCode": "69152-0139-1",
      "PackageDescription": "96 PELLET in 1 BOTTLE (69152-0139-1)",
      "NDC11Code": "69152-0139-01",
      "ProductNDC": "69152-0139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Makros 40 (number 139)",
      "NonProprietaryName": "Chamomilla, Arsenicum Album",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141029",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Paramesh Banerji Life Sciences LLC",
      "SubstanceName": "MATRICARIA RECUTITA; ARSENIC TRIOXIDE",
      "StrengthNumber": "200; 200",
      "StrengthUnit": "[hp_C]/1; [hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps improve hyperkinetic children."
    },
    {
      "NDCCode": "69772-139-40",
      "PackageDescription": "400 mL in 1 BOTTLE (69772-139-40)",
      "NDC11Code": "69772-0139-40",
      "ProductNDC": "69772-139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150423",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "Teresa Cecena DBA Genesis",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": ".01",
      "StrengthUnit": "g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "DIRECTIONS: 1 for maximum dandruff control, use every time you shampoo., 2 wet hair, message onto scalp, rinse, repeat if desired., 3 for best results use at least twice a week or as directed by a doctor."
    },
    {
      "NDCCode": "69945-139-40",
      "PackageDescription": "30 VIAL, MULTI-DOSE in 1 CARTON (69945-139-40)  / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) ",
      "NDC11Code": "69945-0139-40",
      "ProductNDC": "69945-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pulmotech Maa",
      "NonProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
      "RouteName": "INTRAPERITONEAL; INTRAVENOUS",
      "StartMarketingDate": "20200320",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA210089",
      "LabelerName": "Curium US LLC",
      "SubstanceName": "ALBUMIN AGGREGATED",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/15mL",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200320",
      "SamplePackage": "N",
      "IndicationAndUsage": "PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: 1 Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients., 2 Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults.",
      "Description": "PULMOTECH MAA contains albumin aggregated obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The macroaggregated albumin (MAA) particles are formed by heat denaturation of stannous chloride treated albumin human under controlled conditions. Each vial contains 2,000,000 to 4,000,000 particles. The particle size distribution of the aggregated albumin is such that not less than 90% are 10 to 90 micrometers in size. There are no aggregated albumin particles greater than 150 micrometers in size as determined by circular equivalents. PULMOTECH MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection provides a sterile, non-pyrogenic, non-radioactive, white lyophilized powder in a multiple-dose reaction vial, sealed under an atmosphere of nitrogen, for radiolabeling with Sodium Pertechnetate Tc 99m Injection to prepare Technetium Tc 99m Albumin Aggregated Injection, a radioactive diagnostic agent, for intravenous or intraperitoneal use. Each reaction vial contains 2 mg of albumin aggregated, albumin human (7.1 mg), stannous chloride (0.1 mg minimum; 0.22 mg maximum stannous and stannic), sodium chloride (9 mg). Hydrochloric acid may have been added for pH adjustment. The pH is between 5 and 7. It contains no preservatives."
    },
    {
      "NDCCode": "87247-139-19",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (87247-139-19)  / 40 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "87247-0139-19",
      "ProductNDC": "87247-139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sour Lemon Hand Sanitizer Sugar Macaron Scent",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Diamond Life Cosmetics Trading FZCO",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251201",
      "SamplePackage": "N",
      "IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
    },
    {
      "NDCCode": "63323-102-13",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-102-13)  / 5 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0102-13",
      "ProductNDC": "63323-102",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gemcitabine",
      "NonProprietaryName": "Gemcitabine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110726",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090799",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110726",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: : 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) , 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) , 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) , 4 as a single agent for the treatment of pancreatic cancer. (1.4) .",
      "Description": "Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2′-deoxy-2′, 2′-difluorocytidine monohydrochloride (β-isomer) with the following structural formula:. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4  HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder and available as 200 mg, 1 g and 2 g single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Each 2 g vial contains 2 g gemcitabine (equivalent to 2.276 g gemcitabine hydrochloride), 2 g mannitol, and 125 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
    },
    {
      "NDCCode": "63323-102-94",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-102-94)  > 5 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0102-94",
      "ProductNDC": "63323-102",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gemcitabine",
      "NonProprietaryName": "Gemcitabine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110726",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090799",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110726",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: : 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) , 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) , 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) , 4 as a single agent for the treatment of pancreatic cancer. (1.4) .",
      "Description": "Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2′-deoxy-2′, 2′-difluorocytidine monohydrochloride (β-isomer) with the following structural formula:. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4  HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder and available as 200 mg and 1 g single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
    },
    {
      "NDCCode": "63323-125-53",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53)  / 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0125-53",
      "ProductNDC": "63323-125",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gemcitabine",
      "NonProprietaryName": "Gemcitabine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110726",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090799",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/25mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-22",
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      "ListingRecordCertifiedThrough": "20261231",
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      "IndicationAndUsage": "Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: : 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) , 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) , 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) , 4 as a single agent for the treatment of pancreatic cancer. (1.4) .",
      "Description": "Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2′-deoxy-2′, 2′-difluorocytidine monohydrochloride (β-isomer) with the following structural formula:. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4  HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder and available as 200 mg, 1 g and 2 g single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Each 2 g vial contains 2 g gemcitabine (equivalent to 2.276 g gemcitabine hydrochloride), 2 g mannitol, and 125 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
    },
    {
      "NDCCode": "63323-125-94",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94)  > 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0125-94",
      "ProductNDC": "63323-125",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gemcitabine",
      "NonProprietaryName": "Gemcitabine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110726",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090799",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/25mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-03-03",
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      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
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      "IndicationAndUsage": "Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: : 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) , 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) , 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) , 4 as a single agent for the treatment of pancreatic cancer. (1.4) .",
      "Description": "Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2′-deoxy-2′, 2′-difluorocytidine monohydrochloride (β-isomer) with the following structural formula:. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4  HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder and available as 200 mg and 1 g single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
    },
    {
      "NDCCode": "63323-126-03",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-126-03)  / 50 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0126-03",
      "ProductNDC": "63323-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gemcitabine",
      "NonProprietaryName": "Gemcitabine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110726",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090799",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "g/50mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110726",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: : 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) , 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) , 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) , 4 as a single agent for the treatment of pancreatic cancer. (1.4) .",
      "Description": "Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2′-deoxy-2′, 2′-difluorocytidine monohydrochloride (β-isomer) with the following structural formula:. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4  HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder and available as 200 mg, 1 g and 2 g single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Each 2 g vial contains 2 g gemcitabine (equivalent to 2.276 g gemcitabine hydrochloride), 2 g mannitol, and 125 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
    },
    {
      "NDCCode": "63323-255-03",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-255-03)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-255-01) ",
      "NDC11Code": "63323-0255-03",
      "ProductNDC": "63323-255",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylprednisolone Sodium Succinate",
      "NonProprietaryName": "Methylprednisolone Sodium Succinate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20041130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040583",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20041130",
      "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 Methylprednisolone Sodium Succinate for Injection sterile powder 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, selected 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: Acute exacerbations of multiple sclerosis; 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": "Methylprednisolone Sodium Succinate for Injection, USP sterile powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20- dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β). The structural formula is represented below:. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone Sodium Succinate for Injection, USP is available in three strengths for intravenous or intramuscular administration. 40 mg (Single-Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried and 25 mg lactose hydrous; and benzyl alcohol. 125 mg (Single-Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried; and benzyl alcohol. 1 g (Multiple Dose Vial ) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; and 139.2 mg dibasic sodium phosphate dried; and benzyl alcohol. IMPORTANT- Use only Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting Methylprednisolone Sodium Succinate for Injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar; for the 1 g per 16 mL solution is 0.40 osmolar. (Isotonic saline = 0.28 osmolar)."
    },
    {
      "NDCCode": "63323-258-03",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-258-03)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-258-01) ",
      "NDC11Code": "63323-0258-03",
      "ProductNDC": "63323-258",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylprednisolone Sodium Succinate",
      "NonProprietaryName": "Methylprednisolone Sodium Succinate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20041130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040583",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
      "StrengthNumber": "125",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
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      "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 Methylprednisolone Sodium Succinate for Injection sterile powder 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, selected 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: Acute exacerbations of multiple sclerosis; 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": "Methylprednisolone Sodium Succinate for Injection, USP sterile powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20- dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β). The structural formula is represented below:. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone Sodium Succinate for Injection, USP is available in three strengths for intravenous or intramuscular administration. 40 mg (Single-Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried and 25 mg lactose hydrous; and benzyl alcohol. 125 mg (Single-Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried; and benzyl alcohol. 1 g (Multiple Dose Vial ) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; and 139.2 mg dibasic sodium phosphate dried; and benzyl alcohol. IMPORTANT- Use only Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting Methylprednisolone Sodium Succinate for Injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar; for the 1 g per 16 mL solution is 0.40 osmolar. (Isotonic saline = 0.28 osmolar)."
    },
    {
      "NDCCode": "63323-265-30",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-265-30)  / 16 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "63323-0265-30",
      "ProductNDC": "63323-265",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylprednisolone Sodium Succinate",
      "NonProprietaryName": "Methylprednisolone Sodium Succinate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20041130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040612",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/16mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-10",
      "PackageNdcExcludeFlag": "N",
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      "StartMarketingDatePackage": "20041130",
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      "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 Methylprednisolone Sodium Succinate for Injection sterile powder 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, selected 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: Acute exacerbations of multiple sclerosis; 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": "Methylprednisolone Sodium Succinate for Injection, USP sterile powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20- dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β). The structural formula is represented below:. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone Sodium Succinate for Injection, USP is available in three strengths for intravenous or intramuscular administration. 40 mg (Single-Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried and 25 mg lactose hydrous; and benzyl alcohol. 125 mg (Single-Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried; and benzyl alcohol. 1 g (Multiple Dose Vial ) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; and 139.2 mg dibasic sodium phosphate dried; and benzyl alcohol. IMPORTANT- Use only Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting Methylprednisolone Sodium Succinate for Injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar; for the 1 g per 16 mL solution is 0.40 osmolar. (Isotonic saline = 0.28 osmolar)."
    },
    {
      "NDCCode": "63323-877-15",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15)  / 6 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0877-15",
      "ProductNDC": "63323-877",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nebupent",
      "NonProprietaryName": "Pentamidine Isethionate",
      "DosageFormName": "INHALANT",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20110215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019887",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PENTAMIDINE ISETHIONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/6mL",
      "Pharm_Classes": "Antiprotozoal [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110215",
      "SamplePackage": "N",
      "IndicationAndUsage": "NebuPent is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria. i. a history of one or more episodes of PJP. ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3. These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposi’s sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive NebuPent via the Respirgard® II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p<0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at sometime during the trial. The analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. The results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of NebuPent prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. No dose-response was observed for reduction in overall mortality; however, mortality from PJP was low in all three dosage groups.",
      "Description": "NebuPent (pentamidine isethionate), an antifungal agent, is a nonpyrogenic lyophilized product. After reconstitution with Sterile Water for Injection, USP, NebuPent is administered by inhalation via the Respirgard® II nebulizer [Marquest, Englewood, CO] (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate, 4,4’-[1,5-pentane-diylbis(oxy)]bis-benzenecarboximidamid, is a white crystalline powder soluble in water and glycerin and insoluble in ether, acetone, and chloroform. C19H24N4O22C2H6O4S                            592.68. Each vial contains 300 mg pentamidine isethionate."
    },
    {
      "NDCCode": "14141-139-01",
      "PackageDescription": "1 TUBE in 1 BOX (14141-139-01)  / 30 g in 1 TUBE",
      "NDC11Code": "14141-0139-01",
      "ProductNDC": "14141-139",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Brownie 380-f",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220413",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "BEL STAR S A",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "40; 24",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16571-139-09",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16571-139-09) ",
      "NDC11Code": "16571-0139-09",
      "ProductNDC": "16571-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium, Film Coated",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231020",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209912",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231020",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets are indicated.  To reduce the risk of.   ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.   ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.   ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in.   ○ Adults with primary hyperlipidemia.   ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with.   ○ Primary dysbetalipoproteinemia.   ○ Hypertriglyceridemia.",
      "Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
    },
    {
      "NDCCode": "16571-139-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (16571-139-10) ",
      "NDC11Code": "16571-0139-10",
      "ProductNDC": "16571-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium, Film Coated",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231020",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209912",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231020",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets are indicated.  To reduce the risk of.   ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.   ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.   ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in.   ○ Adults with primary hyperlipidemia.   ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with.   ○ Primary dysbetalipoproteinemia.   ○ Hypertriglyceridemia.",
      "Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
    },
    {
      "NDCCode": "16571-139-50",
      "PackageDescription": "500 TABLET in 1 BOTTLE (16571-139-50) ",
      "NDC11Code": "16571-0139-50",
      "ProductNDC": "16571-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium, Film Coated",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231020",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209912",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231020",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atorvastatin calcium tablets are indicated.  To reduce the risk of.   ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.   ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.   ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in.   ○ Adults with primary hyperlipidemia.   ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with.   ○ Primary dysbetalipoproteinemia.   ○ Hypertriglyceridemia.",
      "Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
    },
    {
      "NDCCode": "16590-139-28",
      "PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (16590-139-28)",
      "NDC11Code": "16590-0139-28",
      "ProductNDC": "16590-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lexapro",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020814",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021323",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: : 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
      "Description": "Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Lexapro (escitalopram oxalate) is available as tablets or as an oral solution. Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor."
    },
    {
      "NDCCode": "16590-139-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-139-30)",
      "NDC11Code": "16590-0139-30",
      "ProductNDC": "16590-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lexapro",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020814",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021323",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: : 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
      "Description": "Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Lexapro (escitalopram oxalate) is available as tablets or as an oral solution. Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor."
    },
    {
      "NDCCode": "16590-139-45",
      "PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (16590-139-45)",
      "NDC11Code": "16590-0139-45",
      "ProductNDC": "16590-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lexapro",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020814",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021323",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: : 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
      "Description": "Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Lexapro (escitalopram oxalate) is available as tablets or as an oral solution. Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor."
    },
    {
      "NDCCode": "16590-139-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16590-139-60)",
      "NDC11Code": "16590-0139-60",
      "ProductNDC": "16590-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lexapro",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020814",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021323",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: : 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
      "Description": "Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Lexapro (escitalopram oxalate) is available as tablets or as an oral solution. Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor."
    },
    {
      "NDCCode": "16590-139-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16590-139-90)",
      "NDC11Code": "16590-0139-90",
      "ProductNDC": "16590-139",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lexapro",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020814",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021323",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: : 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) .",
      "Description": "Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Lexapro (escitalopram oxalate) is available as tablets or as an oral solution. Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor."
    }
  ]
}
                    

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