RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "70518-0212-0",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-0212-0) ",
      "NDC11Code": "70518-0212-00",
      "ProductNDC": "70518-0212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen And Codeine Phosphate",
      "NonProprietaryName": "Acetaminophen And Codeine Phosphate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088628",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
      "StrengthNumber": "300; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170209",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10267-0212-0",
      "PackageDescription": "30200 TABLET in 1 BOX (10267-0212-0)",
      "NDC11Code": "10267-0212-00",
      "ProductNDC": "10267-0212",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Caffeine",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20040501",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Contract Pharmcal Corp.",
      "SubstanceName": "CAFFEINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "51927-0212-0",
      "PackageDescription": "1 kg in 1 BOTTLE (51927-0212-0) ",
      "NDC11Code": "51927-0212-00",
      "ProductNDC": "51927-0212",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160415",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Professional Compounding Centers of America",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-13",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "15-APR-16"
    },
    {
      "NDCCode": "61990-0212-2",
      "PackageDescription": "10 VIAL in 1 CARTON (61990-0212-2)  > 5 mL in 1 VIAL (61990-0212-0) ",
      "NDC11Code": "61990-0212-02",
      "ProductNDC": "61990-0212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200812",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211081",
      "LabelerName": "Apollo Pharmaceuticals Inc.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200812",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine hydrochloride Injection, 10 mg/mL is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
      "Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist.  Phenylephrine hydrochloride Injection, 10 mg/mL is a sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride, and its structural formula is depicted below. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether.  Phenylephrine hydrochloride Injection, 10 mg/mL is sensitive to light. Each mL contains: phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5-5.5."
    },
    {
      "NDCCode": "62106-0212-0",
      "PackageDescription": "30 mL in 1 BOTTLE, GLASS (62106-0212-0) ",
      "NDC11Code": "62106-0212-00",
      "ProductNDC": "62106-0212",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hypothalamus",
      "NonProprietaryName": "Hypothalamus",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181218",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Seroyal USA",
      "SubstanceName": "ORYCTOLAGUS CUNICULUS HYPOTHALAMUS",
      "StrengthNumber": "4",
      "StrengthUnit": "[hp_C]/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20181218",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66406-0212-0",
      "PackageDescription": "9435 TABLET in 1 DRUM (66406-0212-0)",
      "NDC11Code": "66406-0212-00",
      "ProductNDC": "66406-0212",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Atazanavir And Cobicistat",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20150129",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Inc.",
      "SubstanceName": "ATAZANAVIR SULFATE; COBICISTAT",
      "StrengthNumber": "300; 150",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "66558-0212-0",
      "PackageDescription": "5 kg in 1 CONTAINER (66558-0212-0) ",
      "NDC11Code": "66558-0212-00",
      "ProductNDC": "66558-0212",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Ceftazidime, Avibactam Sodium",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230519",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Fresenius Kabi iPSUM S.r.l.",
      "SubstanceName": "AVIBACTAM SODIUM; CEFTAZIDIME",
      "StrengthNumber": ".2; .8",
      "StrengthUnit": "kg/kg; kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-07-01",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19-MAY-23"
    },
    {
      "NDCCode": "0409-0212-01",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-01)  / 10 mL in 1 VIAL, SINGLE-DOSE (0409-0212-10) ",
      "NDC11Code": "00409-0212-01",
      "ProductNDC": "0409-0212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203280",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.",
      "Description": "Milrinone Lactate Injection, is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-Dihydro-2-methyl-6-oxo[3,4'-bipyridine]-5-carbonitrile lactate and has the following structural formula. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as a sterile aqueous solution of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials: Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous in Water for Injection. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously."
    },
    {
      "NDCCode": "0409-0212-02",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-02)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-0212-11) ",
      "NDC11Code": "00409-0212-02",
      "ProductNDC": "0409-0212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203280",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.",
      "Description": "Milrinone Lactate Injection, is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-Dihydro-2-methyl-6-oxo[3,4'-bipyridine]-5-carbonitrile lactate and has the following structural formula. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as a sterile aqueous solution of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials: Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous in Water for Injection. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously."
    },
    {
      "NDCCode": "0409-0212-03",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0212-03)  / 50 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00409-0212-03",
      "ProductNDC": "0409-0212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203280",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.",
      "Description": "Milrinone Lactate Injection, is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-Dihydro-2-methyl-6-oxo[3,4'-bipyridine]-5-carbonitrile lactate and has the following structural formula. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as a sterile aqueous solution of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials: Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous in Water for Injection. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously."
    },
    {
      "NDCCode": "10544-212-06",
      "PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (10544-212-06)",
      "NDC11Code": "10544-0212-06",
      "ProductNDC": "10544-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone",
      "NonProprietaryName": "Dexamethasone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088238",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "DEXAMETHASONE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness.",
      "Description": "Dexamethasone Tablets 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg are for oral administration. Each tablet contains 0.5 mg, 0.75 mg, 1.5 mg, 4 mg or 6 mg of dexamethasone. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. Each tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid. In addition, the 0.5 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. The 0.75 mg tablet contains D&C Yellow #10 and FD&C Blue #1. The 1.5 mg tablet contains FD&C Red #40. The 6 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6."
    },
    {
      "NDCCode": "22840-0212-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0212-2) ",
      "NDC11Code": "22840-0212-02",
      "ProductNDC": "22840-0212",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Sweet Vernal Grass Pollen",
      "NonProprietaryName": "Anthoxanthum Odoratum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101842",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0212-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0212-4) ",
      "NDC11Code": "22840-0212-04",
      "ProductNDC": "22840-0212",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Sweet Vernal Grass Pollen",
      "NonProprietaryName": "Anthoxanthum Odoratum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101842",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0212-5",
      "PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0212-5) ",
      "NDC11Code": "22840-0212-05",
      "ProductNDC": "22840-0212",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Sweet Vernal Grass Pollen",
      "NonProprietaryName": "Anthoxanthum Odoratum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101842",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "33342-212-07",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-212-07) ",
      "NDC11Code": "33342-0212-07",
      "ProductNDC": "33342-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200824",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206156",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200824",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.",
      "Description": "Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride extended-release tablets, 0.375 mg. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 0.75 mg. Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 1.5 mg. Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 2.25 mg. Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 3 mg. Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 3.75 mg. Each extended-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 3.53 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 4.5 mg. Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride, USP. Inactive ingredients for all strengths of pramipexole dihydrochloride extended-release tablets consist of hypromellose, mannitol, pregelatinized starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate."
    },
    {
      "NDCCode": "33342-212-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-212-12)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "33342-0212-12",
      "ProductNDC": "33342-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200824",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206156",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200824",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.",
      "Description": "Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride extended-release tablets, 0.375 mg. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 0.75 mg. Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 1.5 mg. Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 2.25 mg. Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 3 mg. Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 3.75 mg. Each extended-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 3.53 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 4.5 mg. Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride, USP. Inactive ingredients for all strengths of pramipexole dihydrochloride extended-release tablets consist of hypromellose, mannitol, pregelatinized starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate."
    },
    {
      "NDCCode": "44567-212-01",
      "PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-212-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE",
      "NDC11Code": "44567-0212-01",
      "ProductNDC": "44567-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin And Sulbactam",
      "NonProprietaryName": "Ampicillin And Sulbactam",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20051125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065188",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
      "StrengthNumber": "10; 5",
      "StrengthUnit": "g/1; g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20151125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin and Sulbactam for Injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*),Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. NOTE: For information on use in pediatric patients see PRECAUTIONS, Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat 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.",
      "Description": "Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection, USP is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a vial containing a sterile preparation for parenteral use. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR USE, Directions for Proper Use of Pharmacy Bulk Package section). Each 15 g vial contains ampicillin 10 g and sulbactam 5 g (equivalent to 10.627 g ampicillin sodium and 5.470 g sulbactam sodium). Each 1.5 g of Ampicillin and Sulbactam for Injection, USP contains approximately 115 mg of sodium."
    },
    {
      "NDCCode": "46163-212-92",
      "PackageDescription": "5 BAG in 1 CARTON (46163-212-92)  / 2000 mL in 1 BAG",
      "NDC11Code": "46163-0212-92",
      "ProductNDC": "46163-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "20240829",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care de Mexico, S.A. de C.V.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240829",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "46163-212-94",
      "PackageDescription": "5 BAG in 1 CARTON (46163-212-94)  / 2500 mL in 1 BAG",
      "NDC11Code": "46163-0212-94",
      "ProductNDC": "46163-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "20240829",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care de Mexico, S.A. de C.V.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240829",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "46163-212-95",
      "PackageDescription": "5 BAG in 1 CARTON (46163-212-95)  / 2000 mL in 1 BAG",
      "NDC11Code": "46163-0212-95",
      "ProductNDC": "46163-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "20240829",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care de Mexico, S.A. de C.V.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240829",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-23",
      "PackageDescription": "6 BAG in 1 CARTON (49230-212-23)  / 2000 mL in 1 BAG",
      "NDC11Code": "49230-0212-23",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "18.4; 4.25; 5.08; 538; 448",
      "StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2 6H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-30",
      "PackageDescription": "4 BAG in 1 CARTON (49230-212-30)  / 3000 mL in 1 BAG",
      "NDC11Code": "49230-0212-30",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-32",
      "PackageDescription": "4 BAG in 1 CARTON (49230-212-32)  / 3000 mL in 1 BAG",
      "NDC11Code": "49230-0212-32",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-50",
      "PackageDescription": "2 BAG in 1 CARTON (49230-212-50)  / 5000 mL in 1 BAG",
      "NDC11Code": "49230-0212-50",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-52",
      "PackageDescription": "2 BAG in 1 CARTON (49230-212-52)  / 5000 mL in 1 BAG",
      "NDC11Code": "49230-0212-52",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-62",
      "PackageDescription": "2 BAG in 1 CARTON (49230-212-62)  / 6000 mL in 1 BAG",
      "NDC11Code": "49230-0212-62",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (standard and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C 6H 12O 6H 2O) a hexose sugar freely soluble in water. The structural formula is shown here:. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH)COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from flexible plastic, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-92",
      "PackageDescription": "5 BAG in 1 CARTON (49230-212-92)  / 2000 mL in 1 BAG",
      "NDC11Code": "49230-0212-92",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-94",
      "PackageDescription": "5 BAG in 1 CARTON (49230-212-94)  / 2500 mL in 1 BAG",
      "NDC11Code": "49230-0212-94",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49230-212-95",
      "PackageDescription": "4 BAG in 1 CARTON (49230-212-95)  / 3000 mL in 1 BAG",
      "NDC11Code": "49230-0212-95",
      "ProductNDC": "49230-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Delflex",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAPERITONEAL",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020171",
      "LabelerName": "Fresenius Medical Care Renal Therapies Group, LLC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "4.25; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920819",
      "SamplePackage": "N",
      "IndicationAndUsage": "DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.",
      "Description": "The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. The staysafe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2. Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6H2O) a hexose sugar freely soluble in water. The structural formula is shown here. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 22H 2O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 26H 2O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3CH(OH) COONa), a 60% aqueous solution miscible in water. Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers."
    },
    {
      "NDCCode": "49288-0212-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0212-1)",
      "NDC11Code": "49288-0212-01",
      "ProductNDC": "49288-0212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Grain Smut Mixture",
      "NonProprietaryName": "Grain Smut Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19970909",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI",
      "StrengthNumber": ".0125; .0125; .0125; .0125",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"70518-0212-0","ProprietaryName":"Acetaminophen And Codeine Phosphate","NonProprietaryName":"Acetaminophen And Codeine Phosphate"},{"NDCCode":"10267-0212-0","NonProprietaryName":"Caffeine"},{"NDCCode":"51927-0212-0","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"61990-0212-2","ProprietaryName":"Phenylephrine Hydrochloride","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"62106-0212-0","ProprietaryName":"Hypothalamus","NonProprietaryName":"Hypothalamus"},{"NDCCode":"66406-0212-0","NonProprietaryName":"Atazanavir And Cobicistat"},{"NDCCode":"66558-0212-0","NonProprietaryName":"Ceftazidime, Avibactam Sodium"},{"NDCCode":"0409-0212-01","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"0409-0212-02","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"0409-0212-03","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"10544-212-06","ProprietaryName":"Dexamethasone","NonProprietaryName":"Dexamethasone"},{"NDCCode":"22840-0212-2","ProprietaryName":"Standardized Sweet Vernal Grass Pollen","NonProprietaryName":"Anthoxanthum Odoratum"},{"NDCCode":"22840-0212-4","ProprietaryName":"Standardized Sweet Vernal Grass Pollen","NonProprietaryName":"Anthoxanthum Odoratum"},{"NDCCode":"22840-0212-5","ProprietaryName":"Standardized Sweet Vernal Grass Pollen","NonProprietaryName":"Anthoxanthum Odoratum"},{"NDCCode":"33342-212-07","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"33342-212-12","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"44567-212-01","ProprietaryName":"Ampicillin And Sulbactam","NonProprietaryName":"Ampicillin And Sulbactam"},{"NDCCode":"46163-212-92","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"46163-212-94","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"46163-212-95","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-23","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-30","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-32","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-50","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-52","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-62","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-92","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-94","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49230-212-95","ProprietaryName":"Delflex","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride"},{"NDCCode":"49288-0212-1","ProprietaryName":"Grain Smut Mixture","NonProprietaryName":"Grain Smut Mixture"}]}
                    

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Lactate</ProprietaryName><NonProprietaryName>Milrinone Lactate</NonProprietaryName></NDC><NDC><NDCCode>0409-0212-02</NDCCode><ProprietaryName>Milrinone Lactate</ProprietaryName><NonProprietaryName>Milrinone Lactate</NonProprietaryName></NDC><NDC><NDCCode>0409-0212-03</NDCCode><ProprietaryName>Milrinone Lactate</ProprietaryName><NonProprietaryName>Milrinone Lactate</NonProprietaryName></NDC><NDC><NDCCode>10544-212-06</NDCCode><ProprietaryName>Dexamethasone</ProprietaryName><NonProprietaryName>Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>22840-0212-2</NDCCode><ProprietaryName>Standardized Sweet Vernal Grass Pollen</ProprietaryName><NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName></NDC><NDC><NDCCode>22840-0212-4</NDCCode><ProprietaryName>Standardized Sweet Vernal Grass Pollen</ProprietaryName><NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName></NDC><NDC><NDCCode>22840-0212-5</NDCCode><ProprietaryName>Standardized Sweet Vernal Grass Pollen</ProprietaryName><NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName></NDC><NDC><NDCCode>33342-212-07</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33342-212-12</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>44567-212-01</NDCCode><ProprietaryName>Ampicillin And Sulbactam</ProprietaryName><NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName></NDC><NDC><NDCCode>46163-212-92</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>46163-212-94</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>46163-212-95</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-23</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-30</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-32</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-50</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-52</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-62</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-92</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-94</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49230-212-95</NDCCode><ProprietaryName>Delflex</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49288-0212-1</NDCCode><ProprietaryName>Grain Smut Mixture</ProprietaryName><NonProprietaryName>Grain Smut Mixture</NonProprietaryName></NDC></NDCList>