RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (11 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "63323-229-95",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-95)  / 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0229-95",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-02-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20001018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
      "Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
    },
    {
      "NDCCode": "41520-229-95",
      "PackageDescription": "1 BOTTLE in 1 CARTON (41520-229-95)  > 45 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "41520-0229-95",
      "ProductNDC": "41520-229",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Careone Allergy Relief",
      "NonProprietaryName": "Fexofenadine Hcl",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161014",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076447",
      "LabelerName": "American Sales Company",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161014",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "63323-010-95",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-95)  / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42) ",
      "NDC11Code": "63323-0010-95",
      "ProductNDC": "63323-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gentamicin",
      "NonProprietaryName": "Gentamicin Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20000810",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062366",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GENTAMICIN SULFATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20000810",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown gentamicin injection to be effective in bacterial neonatal sepsis; bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection and the important additional concepts contained in the BOXED WARNINGS. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents. consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for treatment of endocarditis caused by group D streptococci. Gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin injection may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.",
      "Description": "Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete. It has the following structural formula. Gentamicin injection is a sterile, nonpyrogenic aqueous solution for parenteral administration. Each mL contains: Gentamicin sulfate equivalent to 40 mg gentamicin, methylparaben 1.8 mg and propylparaben 0.2 mg as preservatives, sodium metabisulfite 3.2 mg and edetate disodium 0.1 mg, Water for Injection q.s. Sodium hydroxide and/or sulfuric acid may have been added for pH adjustment."
    },
    {
      "NDCCode": "63323-173-95",
      "PackageDescription": "25 VIAL in 1 TRAY (63323-173-95)  / 2 mL in 1 VIAL",
      "NDC11Code": "63323-0173-95",
      "ProductNDC": "63323-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gentamicin",
      "NonProprietaryName": "Gentamicin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20041129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062366",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GENTAMICIN SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20041129",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown Gentamicin Injection to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).  Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing.  The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the WARNINGS  box above.  If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin type drug before obtaining results of susceptibility testing.  If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin.  Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa.  It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci. Gentamicin Injection has also been shown to be effective in the treatment of serious staphylococcal infections.  While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use.  It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.",
      "Description": "Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from Micromonospora  purpurea, an actinomycete. It has the following structural formula. Gentamicin Injection is a sterile, nonpyrogenic, aqueous solution for parenteral administration and is available both with and without preservatives. Each mL of the preservative free product contains: Gentamicin sulfate, equivalent to gentamicin 10 mg; Water for Injection q.s.  Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment (3 to 5.5)."
    },
    {
      "NDCCode": "63323-286-95",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-286-95)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-93) ",
      "NDC11Code": "63323-0286-95",
      "ProductNDC": "63323-286",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naropin",
      "NonProprietaryName": "Ropivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20090804",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020533",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-08-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090804",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
      "Description": "NAROPIN® Injection is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. NAROPIN® Injection is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula:. C17H26N2OHClH2O                     M.W. 328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. NAROPIN (ropivacaine hydrochloride) injection is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of NAROPIN Injection solutions range from 1.002 to 1.005 at 25°C."
    },
    {
      "NDCCode": "63323-568-95",
      "PackageDescription": "10 SYRINGE in 1 CARTON (63323-568-95)  > 1 mL in 1 SYRINGE",
      "NDC11Code": "63323-0568-95",
      "ProductNDC": "63323-568",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Enoxaparin Sodium",
      "NonProprietaryName": "Enoxaparin Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20150315",
      "EndMarketingDate": "20211031",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020164",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ENOXAPARIN SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150315",
      "EndMarketingDatePackage": "20210930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-569-95",
      "PackageDescription": "10 SYRINGE in 1 CARTON (63323-569-95)  > 1 mL in 1 SYRINGE",
      "NDC11Code": "63323-0569-95",
      "ProductNDC": "63323-569",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Enoxaparin Sodium",
      "NonProprietaryName": "Enoxaparin Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20150315",
      "EndMarketingDate": "20200531",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA020164",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ENOXAPARIN SODIUM",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150315",
      "EndMarketingDatePackage": "20200531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-229-05",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-01) ",
      "NDC11Code": "63323-0229-05",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20001018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
      "Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic. They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6.0 and 7.0. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate. It acts as a heparin antagonist. It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
    },
    {
      "NDCCode": "63323-229-15",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-15)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-21) ",
      "NDC11Code": "63323-0229-15",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20001018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
      "Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
    },
    {
      "NDCCode": "63323-229-25",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-25)  > 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0229-25",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20001018",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-229-26",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-26)  / 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0229-26",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20001018",
      "EndMarketingDatePackage": "20241130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
      "Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
    },
    {
      "NDCCode": "63323-229-30",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-30)  / 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0229-30",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20001018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
      "Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic. They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6.0 and 7.0. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate. It acts as a heparin antagonist. It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
    },
    {
      "NDCCode": "63323-229-35",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-35)  / 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0229-35",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20001018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
      "Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
    },
    {
      "NDCCode": "63323-229-94",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-94)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-41) ",
      "NDC11Code": "63323-0229-94",
      "ProductNDC": "63323-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Protamine Sulfate",
      "NonProprietaryName": "Protamine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20001018",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089454",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "PROTAMINE SULFATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-02-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20001018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.",
      "Description": "Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously."
    },
    {
      "NDCCode": "10812-229-01",
      "PackageDescription": "1 TUBE in 1 BLISTER PACK (10812-229-01)  > 10.4 g in 1 TUBE",
      "NDC11Code": "10812-0229-01",
      "ProductNDC": "10812-229",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Healthy Skin 3 In 1 Concealer For Eyes",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf20 - Fair",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130524",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Neutrogena Corporation",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "95",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-21",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "82449-229-01",
      "PackageDescription": "1 VIAL in 1 CARTON (82449-229-01)  / 50 mL in 1 VIAL",
      "NDC11Code": "82449-0229-01",
      "ProductNDC": "82449-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hydrochloride",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION",
      "StartMarketingDate": "20230609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091503",
      "LabelerName": "Steriscience Specialties Private Limited",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230609",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [ see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [ see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].",
      "Description": "Bupivacaine hydrochloride injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use.[s ee Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride injection is a clear and colorless sterile isotonic solution. Each mL of multiple-dose vial contains 2.5 mg, 5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5 in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative."
    },
    {
      "NDCCode": "63323-597-10",
      "PackageDescription": "1 VIAL in 1 BOX (63323-597-10)  / 5.3 mL in 1 VIAL",
      "NDC11Code": "63323-0597-10",
      "ProductNDC": "63323-597",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Deferoxamine",
      "NonProprietaryName": "Deferoxamine Mesylate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20091215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078718",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEFEROXAMINE MESYLATE",
      "StrengthNumber": "95",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron Chelating Activity [MoA], Iron Chelator [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: : 1 As an adjunct to standard measures for the treatment of acute iron intoxication. (1.1) , 2 For the treatment of transfusional iron overload in patients with chronic anemia. (1.2) .",
      "Description": "Deferoxamine Mesylate for Injection, USP is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine Mesylate for Injection, USP is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 g of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N- [5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N- hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesul-fonate (salt), and its structural formula is:. Deferoxamine mesylate is a white to almost white powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol."
    },
    {
      "NDCCode": "63323-599-30",
      "PackageDescription": "1 VIAL in 1 BOX (63323-599-30)  / 21.1 mL in 1 VIAL",
      "NDC11Code": "63323-0599-30",
      "ProductNDC": "63323-599",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Deferoxamine",
      "NonProprietaryName": "Deferoxamine Mesylate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20091215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078718",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DEFEROXAMINE MESYLATE",
      "StrengthNumber": "95",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron Chelating Activity [MoA], Iron Chelator [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: : 1 As an adjunct to standard measures for the treatment of acute iron intoxication. (1.1) , 2 For the treatment of transfusional iron overload in patients with chronic anemia. (1.2) .",
      "Description": "Deferoxamine Mesylate for Injection, USP is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine Mesylate for Injection, USP is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 g of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N- [5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N- hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesul-fonate (salt), and its structural formula is:. Deferoxamine mesylate is a white to almost white powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol."
    },
    {
      "NDCCode": "63323-617-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-617-01) ",
      "NDC11Code": "63323-0617-10",
      "ProductNDC": "63323-617",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075936",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20020801",
      "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 structure:. C12H9N3O                                         M.W. 211.2. Milrinone is an off-white to tan crystalline compound.  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 sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, 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, USP, in Water for Injection, USP.  The pH is adjusted to between 3.2 and 4.0 with lactic acid 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": "63323-617-20",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-617-02) ",
      "NDC11Code": "63323-0617-20",
      "ProductNDC": "63323-617",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075936",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20020801",
      "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 structure:. C12H9N3O                                         M.W. 211.2. Milrinone is an off-white to tan crystalline compound.  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 sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, 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, USP, in Water for Injection, USP.  The pH is adjusted to between 3.2 and 4.0 with lactic acid 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": "63323-617-50",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50)  / 50 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "63323-0617-50",
      "ProductNDC": "63323-617",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075936",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20020801",
      "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 structure:. C12H9N3O                                         M.W. 211.2. Milrinone is an off-white to tan crystalline compound.  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 sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, 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, USP, in Water for Injection, USP.  The pH is adjusted to between 3.2 and 4.0 with lactic acid 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": "0173-0662-00",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0173-0662-00) ",
      "NDC11Code": "00173-0662-00",
      "ProductNDC": "0173-0662",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epivir",
      "ProprietaryNameSuffix": "Hbv",
      "NonProprietaryName": "Lamivudine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19981217",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021003",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "LAMIVUDINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19981217",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "EPIVIR-HBV is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)]. The following points should be considered when initiating therapy with EPIVIR-HBV: 1 Due to high rates of resistance development in treated patients, initiation of treatment with EPIVIR-HBV should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate., 2 EPIVIR-HBV has not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus., 3 EPIVIR-HBV has not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.",
      "Description": "EPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR-HBV tablets are for oral administration. Each tablet contains 100 mg of lamivudine and the inactive ingredients hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide. EPIVIR-HBV oral solution is for oral administration. One milliliter (1 mL) of EPIVIR-HBV oral solution contains 5 mg of lamivudine (5 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg)."
    },
    {
      "NDCCode": "0173-0663-00",
      "PackageDescription": "240 mL in 1 BOTTLE (0173-0663-00) ",
      "NDC11Code": "00173-0663-00",
      "ProductNDC": "0173-0663",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epivir",
      "ProprietaryNameSuffix": "Hbv",
      "NonProprietaryName": "Lamivudine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19981223",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021004",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "LAMIVUDINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19981223",
      "SamplePackage": "N",
      "IndicationAndUsage": "EPIVIR-HBV is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)]. The following points should be considered when initiating therapy with EPIVIR-HBV: 1 Due to high rates of resistance development in treated patients, initiation of treatment with EPIVIR-HBV should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate., 2 EPIVIR-HBV has not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus., 3 EPIVIR-HBV has not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.",
      "Description": "EPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR-HBV tablets are for oral administration. Each tablet contains 100 mg of lamivudine and the inactive ingredients hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide. EPIVIR-HBV oral solution is for oral administration. One milliliter (1 mL) of EPIVIR-HBV oral solution contains 5 mg of lamivudine (5 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg)."
    },
    {
      "NDCCode": "10135-605-71",
      "PackageDescription": "240 mL in 1 BOTTLE, PLASTIC (10135-605-71)",
      "NDC11Code": "10135-0605-71",
      "ProductNDC": "10135-605",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamivudine",
      "NonProprietaryName": "Lamivudine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203564",
      "LabelerName": "Marlex Pharmaceuticals Inc",
      "SubstanceName": "LAMIVUDINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Lamivudine Oral Solution, USP is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.",
      "Description": "Lamivudine USP (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4- amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)- (1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′- dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C. Lamivudine Oral Solution, USP is for oral administration. One milliliter (1 mL) of Lamivudine Oral Solution, USP contains 10 mg of lamivudine ( 10 mg/mL) in solution and the inactive ingredients alcohol (5% v/v), edetate disodium, artificial strawberry flavor, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), sucrose (200 mg) and purified water."
    },
    {
      "NDCCode": "10202-229-66",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (10202-229-66)  > 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "10202-0229-66",
      "ProductNDC": "10202-229",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fexofenadine Hydrochloride",
      "NonProprietaryName": "Fexofenadine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202039",
      "LabelerName": "7-eleven",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-06-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150115",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper resporatory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat."
    },
    {
      "NDCCode": "10544-229-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (10544-229-30)",
      "NDC11Code": "10544-0229-30",
      "ProductNDC": "10544-229",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120213",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021210",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": ".05",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.",
      "Description": "Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T 4 is identical to that produced in the human thyroid gland. Levothyroxine (T 4) sodium has an empirical formula of C 15H 10I 4N NaO 4  H 2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:."
    },
    {
      "NDCCode": "10596-001-01",
      "PackageDescription": "1 TUBE in 1 CARTON (10596-001-01)  / 5.2 g in 1 TUBE",
      "NDC11Code": "10596-0001-01",
      "ProductNDC": "10596-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Berry Balmy",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241112",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Kao USA Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "229.5",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241112",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun. ."
    },
    {
      "NDCCode": "10596-002-01",
      "PackageDescription": "1 TUBE in 1 CARTON (10596-002-01)  / 5.2 g in 1 TUBE",
      "NDC11Code": "10596-0002-01",
      "ProductNDC": "10596-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Vanilla Cloud",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241112",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Kao USA Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "229.5",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241112",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun. ."
    },
    {
      "NDCCode": "11054-005-06",
      "PackageDescription": "229 L in 1 CYLINDER (11054-005-06) ",
      "NDC11Code": "11054-0005-06",
      "ProductNDC": "11054-005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrogen",
      "ProprietaryNameSuffix": "Compressed, Nf",
      "NonProprietaryName": "Nitrogen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19971106",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205839",
      "LabelerName": "AIRGAS USA, LLC",
      "SubstanceName": "NITROGEN",
      "StrengthNumber": "992",
      "StrengthUnit": "mL/L",
      "Status": "Active",
      "LastUpdate": "2026-06-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19971106",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11410-229-01",
      "PackageDescription": "1 KIT in 1 BOX (11410-229-01)  *  60 mL in 1 TUBE (11410-457-15)  *  30 mL in 1 TUBE",
      "NDC11Code": "11410-0229-01",
      "ProductNDC": "11410-229",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Proactiv Clean Beginner Bundle",
      "NonProprietaryName": "Clean Kit",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240508",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "Alchemee, LLC",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240508",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the management of acne."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"63323-229-95","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"41520-229-95","ProprietaryName":"Careone Allergy Relief","NonProprietaryName":"Fexofenadine Hcl"},{"NDCCode":"63323-010-95","ProprietaryName":"Gentamicin","NonProprietaryName":"Gentamicin Sulfate"},{"NDCCode":"63323-173-95","ProprietaryName":"Gentamicin","NonProprietaryName":"Gentamicin"},{"NDCCode":"63323-286-95","ProprietaryName":"Naropin","NonProprietaryName":"Ropivacaine Hydrochloride"},{"NDCCode":"63323-568-95","ProprietaryName":"Enoxaparin Sodium","NonProprietaryName":"Enoxaparin Sodium"},{"NDCCode":"63323-569-95","ProprietaryName":"Enoxaparin Sodium","NonProprietaryName":"Enoxaparin Sodium"},{"NDCCode":"63323-229-05","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"63323-229-15","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"63323-229-25","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"63323-229-26","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"63323-229-30","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"63323-229-35","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"63323-229-94","ProprietaryName":"Protamine Sulfate","NonProprietaryName":"Protamine Sulfate"},{"NDCCode":"10812-229-01","ProprietaryName":"Neutrogena Healthy Skin 3 In 1 Concealer For Eyes","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"82449-229-01","ProprietaryName":"Bupivacaine Hydrochloride","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"63323-597-10","ProprietaryName":"Deferoxamine","NonProprietaryName":"Deferoxamine Mesylate"},{"NDCCode":"63323-599-30","ProprietaryName":"Deferoxamine","NonProprietaryName":"Deferoxamine Mesylate"},{"NDCCode":"63323-617-10","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"63323-617-20","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"63323-617-50","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"0173-0662-00","ProprietaryName":"Epivir","NonProprietaryName":"Lamivudine"},{"NDCCode":"0173-0663-00","ProprietaryName":"Epivir","NonProprietaryName":"Lamivudine"},{"NDCCode":"10135-605-71","ProprietaryName":"Lamivudine","NonProprietaryName":"Lamivudine"},{"NDCCode":"10202-229-66","ProprietaryName":"Fexofenadine Hydrochloride","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"10544-229-30","ProprietaryName":"Levothyroxine Sodium","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"10596-001-01","ProprietaryName":"Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Berry Balmy","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"10596-002-01","ProprietaryName":"Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Vanilla Cloud","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"11054-005-06","ProprietaryName":"Nitrogen","NonProprietaryName":"Nitrogen"},{"NDCCode":"11410-229-01","ProprietaryName":"Proactiv Clean Beginner Bundle","NonProprietaryName":"Clean Kit"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>63323-229-95</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-95)  / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>63323-0229-95</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
    <Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>41520-229-95</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (41520-229-95)  &gt; 45 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>41520-0229-95</NDC11Code>
    <ProductNDC>41520-229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Careone Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161014</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076447</ApplicationNumber>
    <LabelerName>American Sales Company</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63323-010-95</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-95)  / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42) </PackageDescription>
    <NDC11Code>63323-0010-95</NDC11Code>
    <ProductNDC>63323-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gentamicin</ProprietaryName>
    <NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20000810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062366</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GENTAMICIN SULFATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown gentamicin injection to be effective in bacterial neonatal sepsis; bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection and the important additional concepts contained in the BOXED WARNINGS. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents. consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for treatment of endocarditis caused by group D streptococci. Gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin injection may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.</IndicationAndUsage>
    <Description>Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete. It has the following structural formula. Gentamicin injection is a sterile, nonpyrogenic aqueous solution for parenteral administration. Each mL contains: Gentamicin sulfate equivalent to 40 mg gentamicin, methylparaben 1.8 mg and propylparaben 0.2 mg as preservatives, sodium metabisulfite 3.2 mg and edetate disodium 0.1 mg, Water for Injection q.s. Sodium hydroxide and/or sulfuric acid may have been added for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-173-95</NDCCode>
    <PackageDescription>25 VIAL in 1 TRAY (63323-173-95)  / 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>63323-0173-95</NDC11Code>
    <ProductNDC>63323-173</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gentamicin</ProprietaryName>
    <NonProprietaryName>Gentamicin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20041129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062366</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GENTAMICIN SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown Gentamicin Injection to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).  Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing.  The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the WARNINGS  box above.  If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin type drug before obtaining results of susceptibility testing.  If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin.  Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa.  It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci. Gentamicin Injection has also been shown to be effective in the treatment of serious staphylococcal infections.  While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use.  It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.</IndicationAndUsage>
    <Description>Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from Micromonospora  purpurea, an actinomycete. It has the following structural formula. Gentamicin Injection is a sterile, nonpyrogenic, aqueous solution for parenteral administration and is available both with and without preservatives. Each mL of the preservative free product contains: Gentamicin sulfate, equivalent to gentamicin 10 mg; Water for Injection q.s.  Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment (3 to 5.5).</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-286-95</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-286-95)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-93) </PackageDescription>
    <NDC11Code>63323-0286-95</NDC11Code>
    <ProductNDC>63323-286</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naropin</ProprietaryName>
    <NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20090804</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020533</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
    <Description>NAROPIN® Injection is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. NAROPIN® Injection is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula:. C17H26N2OHClH2O                     M.W. 328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. NAROPIN (ropivacaine hydrochloride) injection is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of NAROPIN Injection solutions range from 1.002 to 1.005 at 25°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-568-95</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (63323-568-95)  &gt; 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0568-95</NDC11Code>
    <ProductNDC>63323-568</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150315</StartMarketingDate>
    <EndMarketingDate>20211031</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150315</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-569-95</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (63323-569-95)  &gt; 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>63323-0569-95</NDC11Code>
    <ProductNDC>63323-569</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enoxaparin Sodium</ProprietaryName>
    <NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20150315</StartMarketingDate>
    <EndMarketingDate>20200531</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020164</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150315</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-229-05</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-01) </PackageDescription>
    <NDC11Code>63323-0229-05</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
    <Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic. They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6.0 and 7.0. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate. It acts as a heparin antagonist. It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-229-15</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-15)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-21) </PackageDescription>
    <NDC11Code>63323-0229-15</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
    <Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-229-25</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-25)  &gt; 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>63323-0229-25</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-229-26</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-26)  / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>63323-0229-26</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
    <Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-229-30</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-30)  / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>63323-0229-30</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
    <Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic. They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6.0 and 7.0. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate. It acts as a heparin antagonist. It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-229-35</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-35)  / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>63323-0229-35</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
    <Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-229-94</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-94)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-41) </PackageDescription>
    <NDC11Code>63323-0229-94</NDC11Code>
    <ProductNDC>63323-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Protamine Sulfate</ProprietaryName>
    <NonProprietaryName>Protamine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20001018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089454</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>PROTAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.</IndicationAndUsage>
    <Description>Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish. Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex. Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant. Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment. The preparation is preservative free. Protamine sulfate is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>10812-229-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BLISTER PACK (10812-229-01)  &gt; 10.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>10812-0229-01</NDC11Code>
    <ProductNDC>10812-229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Healthy Skin 3 In 1 Concealer For Eyes</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf20 - Fair</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130524</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Neutrogena Corporation</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>95</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-21</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>82449-229-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (82449-229-01)  / 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>82449-0229-01</NDC11Code>
    <ProductNDC>82449-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION</RouteName>
    <StartMarketingDate>20230609</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091503</ApplicationNumber>
    <LabelerName>Steriscience Specialties Private Limited</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230609</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [ see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [ see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].</IndicationAndUsage>
    <Description>Bupivacaine hydrochloride injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use.[s ee Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride injection is a clear and colorless sterile isotonic solution. Each mL of multiple-dose vial contains 2.5 mg, 5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5 in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-597-10</NDCCode>
    <PackageDescription>1 VIAL in 1 BOX (63323-597-10)  / 5.3 mL in 1 VIAL</PackageDescription>
    <NDC11Code>63323-0597-10</NDC11Code>
    <ProductNDC>63323-597</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Deferoxamine</ProprietaryName>
    <NonProprietaryName>Deferoxamine Mesylate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20091215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078718</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEFEROXAMINE MESYLATE</SubstanceName>
    <StrengthNumber>95</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: : 1 As an adjunct to standard measures for the treatment of acute iron intoxication. (1.1) , 2 For the treatment of transfusional iron overload in patients with chronic anemia. (1.2) .</IndicationAndUsage>
    <Description>Deferoxamine Mesylate for Injection, USP is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine Mesylate for Injection, USP is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 g of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N- [5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N- hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesul-fonate (salt), and its structural formula is:. Deferoxamine mesylate is a white to almost white powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-599-30</NDCCode>
    <PackageDescription>1 VIAL in 1 BOX (63323-599-30)  / 21.1 mL in 1 VIAL</PackageDescription>
    <NDC11Code>63323-0599-30</NDC11Code>
    <ProductNDC>63323-599</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Deferoxamine</ProprietaryName>
    <NonProprietaryName>Deferoxamine Mesylate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20091215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078718</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DEFEROXAMINE MESYLATE</SubstanceName>
    <StrengthNumber>95</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: : 1 As an adjunct to standard measures for the treatment of acute iron intoxication. (1.1) , 2 For the treatment of transfusional iron overload in patients with chronic anemia. (1.2) .</IndicationAndUsage>
    <Description>Deferoxamine Mesylate for Injection, USP is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine Mesylate for Injection, USP is supplied as vials containing 500 mg and 2 g of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 g of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N- [5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N- hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesul-fonate (salt), and its structural formula is:. Deferoxamine mesylate is a white to almost white powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-617-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-617-01) </PackageDescription>
    <NDC11Code>63323-0617-10</NDC11Code>
    <ProductNDC>63323-617</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Milrinone Lactate</ProprietaryName>
    <NonProprietaryName>Milrinone Lactate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075936</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MILRINONE LACTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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.</IndicationAndUsage>
    <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 structure:. C12H9N3O                                         M.W. 211.2. Milrinone is an off-white to tan crystalline compound.  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 sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, 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, USP, in Water for Injection, USP.  The pH is adjusted to between 3.2 and 4.0 with lactic acid 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-617-20</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-617-02) </PackageDescription>
    <NDC11Code>63323-0617-20</NDC11Code>
    <ProductNDC>63323-617</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Milrinone Lactate</ProprietaryName>
    <NonProprietaryName>Milrinone Lactate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075936</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MILRINONE LACTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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.</IndicationAndUsage>
    <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 structure:. C12H9N3O                                         M.W. 211.2. Milrinone is an off-white to tan crystalline compound.  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 sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, 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, USP, in Water for Injection, USP.  The pH is adjusted to between 3.2 and 4.0 with lactic acid 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>63323-617-50</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50)  / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>63323-0617-50</NDC11Code>
    <ProductNDC>63323-617</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Milrinone Lactate</ProprietaryName>
    <NonProprietaryName>Milrinone Lactate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075936</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MILRINONE LACTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <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.</IndicationAndUsage>
    <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 structure:. C12H9N3O                                         M.W. 211.2. Milrinone is an off-white to tan crystalline compound.  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 sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, 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, USP, in Water for Injection, USP.  The pH is adjusted to between 3.2 and 4.0 with lactic acid 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.</Description>
  </NDC>
  <NDC>
    <NDCCode>0173-0662-00</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0173-0662-00) </PackageDescription>
    <NDC11Code>00173-0662-00</NDC11Code>
    <ProductNDC>0173-0662</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epivir</ProprietaryName>
    <ProprietaryNameSuffix>Hbv</ProprietaryNameSuffix>
    <NonProprietaryName>Lamivudine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19981217</StartMarketingDate>
    <EndMarketingDate>20250131</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021003</ApplicationNumber>
    <LabelerName>GlaxoSmithKline LLC</LabelerName>
    <SubstanceName>LAMIVUDINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19981217</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EPIVIR-HBV is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)]. The following points should be considered when initiating therapy with EPIVIR-HBV: 1 Due to high rates of resistance development in treated patients, initiation of treatment with EPIVIR-HBV should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate., 2 EPIVIR-HBV has not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus., 3 EPIVIR-HBV has not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.</IndicationAndUsage>
    <Description>EPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR-HBV tablets are for oral administration. Each tablet contains 100 mg of lamivudine and the inactive ingredients hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide. EPIVIR-HBV oral solution is for oral administration. One milliliter (1 mL) of EPIVIR-HBV oral solution contains 5 mg of lamivudine (5 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>0173-0663-00</NDCCode>
    <PackageDescription>240 mL in 1 BOTTLE (0173-0663-00) </PackageDescription>
    <NDC11Code>00173-0663-00</NDC11Code>
    <ProductNDC>0173-0663</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epivir</ProprietaryName>
    <ProprietaryNameSuffix>Hbv</ProprietaryNameSuffix>
    <NonProprietaryName>Lamivudine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19981223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021004</ApplicationNumber>
    <LabelerName>GlaxoSmithKline LLC</LabelerName>
    <SubstanceName>LAMIVUDINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19981223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EPIVIR-HBV is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)]. The following points should be considered when initiating therapy with EPIVIR-HBV: 1 Due to high rates of resistance development in treated patients, initiation of treatment with EPIVIR-HBV should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate., 2 EPIVIR-HBV has not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus., 3 EPIVIR-HBV has not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.</IndicationAndUsage>
    <Description>EPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR-HBV tablets are for oral administration. Each tablet contains 100 mg of lamivudine and the inactive ingredients hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide. EPIVIR-HBV oral solution is for oral administration. One milliliter (1 mL) of EPIVIR-HBV oral solution contains 5 mg of lamivudine (5 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>10135-605-71</NDCCode>
    <PackageDescription>240 mL in 1 BOTTLE, PLASTIC (10135-605-71)</PackageDescription>
    <NDC11Code>10135-0605-71</NDC11Code>
    <ProductNDC>10135-605</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamivudine</ProprietaryName>
    <NonProprietaryName>Lamivudine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203564</ApplicationNumber>
    <LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
    <SubstanceName>LAMIVUDINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Lamivudine Oral Solution, USP is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.</IndicationAndUsage>
    <Description>Lamivudine USP (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4- amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)- (1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′- dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C. Lamivudine Oral Solution, USP is for oral administration. One milliliter (1 mL) of Lamivudine Oral Solution, USP contains 10 mg of lamivudine ( 10 mg/mL) in solution and the inactive ingredients alcohol (5% v/v), edetate disodium, artificial strawberry flavor, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), sucrose (200 mg) and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>10202-229-66</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (10202-229-66)  &gt; 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>10202-0229-66</NDC11Code>
    <ProductNDC>10202-229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202039</ApplicationNumber>
    <LabelerName>7-eleven</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-06-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper resporatory allergies: 1 runny nose , 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10544-229-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (10544-229-30)</PackageDescription>
    <NDC11Code>10544-0229-30</NDC11Code>
    <ProductNDC>10544-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levothyroxine Sodium</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120213</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021210</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.</IndicationAndUsage>
    <Description>Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T 4 is identical to that produced in the human thyroid gland. Levothyroxine (T 4) sodium has an empirical formula of C 15H 10I 4N NaO 4  H 2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:.</Description>
  </NDC>
  <NDC>
    <NDCCode>10596-001-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10596-001-01)  / 5.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>10596-0001-01</NDC11Code>
    <ProductNDC>10596-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Berry Balmy</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Kao USA Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>229.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10596-002-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10596-002-01)  / 5.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>10596-0002-01</NDC11Code>
    <ProductNDC>10596-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Vanilla Cloud</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Kao USA Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>229.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11054-005-06</NDCCode>
    <PackageDescription>229 L in 1 CYLINDER (11054-005-06) </PackageDescription>
    <NDC11Code>11054-0005-06</NDC11Code>
    <ProductNDC>11054-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrogen</ProprietaryName>
    <ProprietaryNameSuffix>Compressed, Nf</ProprietaryNameSuffix>
    <NonProprietaryName>Nitrogen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19971106</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205839</ApplicationNumber>
    <LabelerName>AIRGAS USA, LLC</LabelerName>
    <SubstanceName>NITROGEN</SubstanceName>
    <StrengthNumber>992</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11410-229-01</NDCCode>
    <PackageDescription>1 KIT in 1 BOX (11410-229-01)  *  60 mL in 1 TUBE (11410-457-15)  *  30 mL in 1 TUBE</PackageDescription>
    <NDC11Code>11410-0229-01</NDC11Code>
    <ProductNDC>11410-229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Proactiv Clean Beginner Bundle</ProprietaryName>
    <NonProprietaryName>Clean Kit</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240508</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Alchemee, LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240508</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the management of acne.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>63323-229-95</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>41520-229-95</NDCCode><ProprietaryName>Careone Allergy Relief</ProprietaryName><NonProprietaryName>Fexofenadine Hcl</NonProprietaryName></NDC><NDC><NDCCode>63323-010-95</NDCCode><ProprietaryName>Gentamicin</ProprietaryName><NonProprietaryName>Gentamicin Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-173-95</NDCCode><ProprietaryName>Gentamicin</ProprietaryName><NonProprietaryName>Gentamicin</NonProprietaryName></NDC><NDC><NDCCode>63323-286-95</NDCCode><ProprietaryName>Naropin</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63323-568-95</NDCCode><ProprietaryName>Enoxaparin Sodium</ProprietaryName><NonProprietaryName>Enoxaparin Sodium</NonProprietaryName></NDC><NDC><NDCCode>63323-569-95</NDCCode><ProprietaryName>Enoxaparin Sodium</ProprietaryName><NonProprietaryName>Enoxaparin Sodium</NonProprietaryName></NDC><NDC><NDCCode>63323-229-05</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-229-15</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-229-25</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-229-26</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-229-30</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-229-35</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>63323-229-94</NDCCode><ProprietaryName>Protamine Sulfate</ProprietaryName><NonProprietaryName>Protamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>10812-229-01</NDCCode><ProprietaryName>Neutrogena Healthy Skin 3 In 1 Concealer For Eyes</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>82449-229-01</NDCCode><ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63323-597-10</NDCCode><ProprietaryName>Deferoxamine</ProprietaryName><NonProprietaryName>Deferoxamine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>63323-599-30</NDCCode><ProprietaryName>Deferoxamine</ProprietaryName><NonProprietaryName>Deferoxamine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>63323-617-10</NDCCode><ProprietaryName>Milrinone Lactate</ProprietaryName><NonProprietaryName>Milrinone Lactate</NonProprietaryName></NDC><NDC><NDCCode>63323-617-20</NDCCode><ProprietaryName>Milrinone Lactate</ProprietaryName><NonProprietaryName>Milrinone Lactate</NonProprietaryName></NDC><NDC><NDCCode>63323-617-50</NDCCode><ProprietaryName>Milrinone Lactate</ProprietaryName><NonProprietaryName>Milrinone Lactate</NonProprietaryName></NDC><NDC><NDCCode>0173-0662-00</NDCCode><ProprietaryName>Epivir</ProprietaryName><NonProprietaryName>Lamivudine</NonProprietaryName></NDC><NDC><NDCCode>0173-0663-00</NDCCode><ProprietaryName>Epivir</ProprietaryName><NonProprietaryName>Lamivudine</NonProprietaryName></NDC><NDC><NDCCode>10135-605-71</NDCCode><ProprietaryName>Lamivudine</ProprietaryName><NonProprietaryName>Lamivudine</NonProprietaryName></NDC><NDC><NDCCode>10202-229-66</NDCCode><ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName><NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10544-229-30</NDCCode><ProprietaryName>Levothyroxine Sodium</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>10596-001-01</NDCCode><ProprietaryName>Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Berry Balmy</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10596-002-01</NDCCode><ProprietaryName>Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Vanilla Cloud</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>11054-005-06</NDCCode><ProprietaryName>Nitrogen</ProprietaryName><NonProprietaryName>Nitrogen</NonProprietaryName></NDC><NDC><NDCCode>11410-229-01</NDCCode><ProprietaryName>Proactiv Clean Beginner Bundle</ProprietaryName><NonProprietaryName>Clean Kit</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
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    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
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}
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