RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (38 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "57469-062-25",
      "PackageDescription": "25 PATCH in 1 POUCH (57469-062-25)  > 1.3 g in 1 PATCH",
      "NDC11Code": "57469-0062-25",
      "ProductNDC": "57469-062",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Disney Planes Fire And Rescue Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bolero Home Decor, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-23"
    },
    {
      "NDCCode": "57469-057-25",
      "PackageDescription": "25 PATCH in 1 POUCH (57469-057-25)  > 1.3 g in 1 PATCH",
      "NDC11Code": "57469-0057-25",
      "ProductNDC": "57469-057",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Disney Princess Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bolero Home Decor, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57469-058-25",
      "PackageDescription": "25 PATCH in 1 POUCH (57469-058-25)  > 1.3 g in 1 PATCH",
      "NDC11Code": "57469-0058-25",
      "ProductNDC": "57469-058",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Disney Minnie Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bolero Home Decor, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57469-059-25",
      "PackageDescription": "25 PATCH in 1 POUCH (57469-059-25)  > 1.3 g in 1 PATCH",
      "NDC11Code": "57469-0059-25",
      "ProductNDC": "57469-059",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Disney Fairies Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bolero Home Decor, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57469-060-25",
      "PackageDescription": "25 PATCH in 1 POUCH (57469-060-25)  > 1.3 g in 1 PATCH",
      "NDC11Code": "57469-0060-25",
      "ProductNDC": "57469-060",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Disney Frozen Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bolero Home Decor, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57469-061-25",
      "PackageDescription": "25 PATCH in 1 POUCH (57469-061-25)  > 1.3 g in 1 PATCH",
      "NDC11Code": "57469-0061-25",
      "ProductNDC": "57469-061",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Marvel Ultimate Spider-man Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bolero Home Decor, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "57469-063-25",
      "PackageDescription": "25 PATCH in 1 POUCH (57469-063-25)  > 1.3 g in 1 PATCH",
      "NDC11Code": "57469-0063-25",
      "ProductNDC": "57469-063",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Disney Pixar Cars Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bolero Home Decor, Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "10738-062-20",
      "PackageDescription": "1 TUBE in 1 CARTON (10738-062-20)  / 62 g in 1 TUBE (10738-062-25) ",
      "NDC11Code": "10738-0062-20",
      "ProductNDC": "10738-062",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triderma Psoriasis Control Face And Body Cream",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191230",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Genuine Virgin Aloe Corporation",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "3",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses relieves and helps prevent recurrence of: itching irritation redness flaking  scaling due to psoriasis and seborrheic dermatitis."
    },
    {
      "NDCCode": "42765-062-25",
      "PackageDescription": "25 kg in 1 DRUM (42765-062-25) ",
      "NDC11Code": "42765-0062-25",
      "ProductNDC": "42765-062",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dexlansoprazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230701",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Metrochem API Private Limited",
      "SubstanceName": "DEXLANSOPRAZOLE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/25kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-02-01",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-JUL-23"
    },
    {
      "NDCCode": "63934-062-01",
      "PackageDescription": "25 kg in 1 DRUM (63934-062-01)",
      "NDC11Code": "63934-0062-01",
      "ProductNDC": "63934-062",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Benzethonium Chloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170822",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Kumar Organic Products Limited",
      "SubstanceName": "4-BUTYLRESORCINOL",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "70069-062-25",
      "PackageDescription": "25 VIAL in 1 CARTON (70069-062-25)  / 20 mL in 1 VIAL (70069-062-01) ",
      "NDC11Code": "70069-0062-25",
      "ProductNDC": "70069-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ropivacaine Hydrochloride",
      "NonProprietaryName": "Ropivacaine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20180615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207636",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ropivacaine hydrochloride injection 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": "Ropivacaine hydrochloride injection, USP 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. Ropivacaine hydrochloride injection, USP 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. Ropivacaine hydrochloride injection, USP 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 mg, 5 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 ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
    },
    {
      "NDCCode": "72572-062-25",
      "PackageDescription": "25 VIAL in 1 BOX (72572-062-25)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72572-062-01) ",
      "NDC11Code": "72572-0062-25",
      "ProductNDC": "72572-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ceftriaxone",
      "NonProprietaryName": "Ceftriaxone",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20200301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065342",
      "LabelerName": "Civica, Inc.",
      "SubstanceName": "CEFTRIAXONE SODIUM",
      "StrengthNumber": "2",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-02-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for 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. Ceftriaxone for Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms. LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta‑lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of Ceftriaxone for Injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose of Ceftriaxone for Injection, USP and the comparator. The potentially lower clinical cure rate of Ceftriaxone for Injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii1, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis1 or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase‑producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for Injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for Injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis1 and Escherichia coli.1. 1Efficacy for this organism in this organ system was studied in fewer than ten infections.",
      "Description": "Ceftriaxone for Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.59 and the following structural formula. Ceftriaxone for Injection, USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity."
    },
    {
      "NDCCode": "73025-062-25",
      "PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (73025-062-25) ",
      "NDC11Code": "73025-0062-25",
      "ProductNDC": "73025-062",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Spatherapy Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Shalom International Corp",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".62",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200601",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73569-062-04",
      "PackageDescription": "25 g in 1 BOTTLE (73569-062-04) ",
      "NDC11Code": "73569-0062-04",
      "ProductNDC": "73569-062",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Hexarelin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20241209",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Peptites Biotech",
      "SubstanceName": "EXAMORELIN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "09-DEC-24"
    },
    {
      "NDCCode": "73687-062-25",
      "PackageDescription": "15 AMPULE in 1 CARTON (73687-062-25)  / .3 mL in 1 AMPULE (73687-062-80) ",
      "NDC11Code": "73687-0062-25",
      "ProductNDC": "73687-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Upneeq",
      "NonProprietaryName": "Oxymetazoline Hydrochloride Ophthalmic",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20200821",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212520",
      "LabelerName": "RVL Pharmaceuticals, Inc.",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200821",
      "SamplePackage": "Y",
      "IndicationAndUsage": "UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults.",
      "Description": "UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% contains oxymetazoline hydrochloride, an alpha adrenoceptor agonist. UPNEEQ is an aseptically prepared, sterile, non-preserved ophthalmic solution. The chemical name is 6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4- dimethylphenol monohydrochloride, and the molecular mass is 296.84. Oxymetazoline HCl is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water. The molecular formula of oxymetazoline HCl is C16H24N2O∙HCl, and its structural formula is. Each mL of UPNEEQ (oxymetazoline hydrochloride ophthalmic solution) 0.1% contains 1 mg of oxymetazoline hydrochloride, equivalent to 0.9 mg (0.09%) of oxymetazoline free base. The ophthalmic solution contains the following inactive ingredients: calcium chloride, hydrochloric acid (used to adjust pH to 5.8 to 6.8), hypromellose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, and water for injection."
    },
    {
      "NDCCode": "75839-062-25",
      "PackageDescription": "25 g in 1 BOTTLE (75839-062-25)",
      "NDC11Code": "75839-0062-25",
      "ProductNDC": "75839-062",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Trilostane",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130411",
      "MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
      "LabelerName": "Attix Pharmaceuticals",
      "SubstanceName": "TRILOSTANE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "83324-062-25",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (83324-062-25)  / 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "83324-0062-25",
      "ProductNDC": "83324-062",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Flu Hbp",
      "NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260217",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Chain Drug Marketing Association, Inc.",
      "SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
      "StrengthNumber": "325; 2; 10",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260217",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: minor aches and painssore throatsneezingheadacherunny nosecough. temporarily reduces fever."
    },
    {
      "NDCCode": "11489-062-01",
      "PackageDescription": "1 JAR in 1 CARTON (11489-062-01)  > 50 mL in 1 JAR",
      "NDC11Code": "11489-0062-01",
      "ProductNDC": "11489-062",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "No7 Time Resisting Day Sunscreen Spf 12",
      "NonProprietaryName": "Octinoxate And Avobenzone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091208",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "BCM Ltd",
      "SubstanceName": "OCTINOXATE; AVOBENZONE",
      "StrengthNumber": "2.5; 1.25",
      "StrengthUnit": "mL/50mL; mL/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "13107-062-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (13107-062-01)",
      "NDC11Code": "13107-0062-01",
      "ProductNDC": "13107-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate",
      "NonProprietaryName": "Metoprolol Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100917",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077739",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "Description": "The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
    },
    {
      "NDCCode": "13107-062-99",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (13107-062-99)",
      "NDC11Code": "13107-0062-99",
      "ProductNDC": "13107-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate",
      "NonProprietaryName": "Metoprolol Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100917",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077739",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "Description": "The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
    },
    {
      "NDCCode": "21922-062-04",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-062-04)  / 15 g in 1 TUBE",
      "NDC11Code": "21922-0062-04",
      "ProductNDC": "21922-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208848",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240316",
      "SamplePackage": "N",
      "IndicationAndUsage": "Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water."
    },
    {
      "NDCCode": "21922-062-05",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-062-05)  / 30 g in 1 TUBE",
      "NDC11Code": "21922-0062-05",
      "ProductNDC": "21922-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208848",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240316",
      "SamplePackage": "N",
      "IndicationAndUsage": "Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water."
    },
    {
      "NDCCode": "21922-062-15",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-062-15)  / 80 g in 1 TUBE",
      "NDC11Code": "21922-0062-15",
      "ProductNDC": "21922-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208848",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240316",
      "SamplePackage": "N",
      "IndicationAndUsage": "Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water."
    },
    {
      "NDCCode": "21922-062-30",
      "PackageDescription": "454 g in 1 JAR (21922-062-30) ",
      "NDC11Code": "21922-0062-30",
      "ProductNDC": "21922-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208848",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240316",
      "SamplePackage": "N",
      "IndicationAndUsage": "Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water."
    },
    {
      "NDCCode": "35356-062-05",
      "PackageDescription": "5 PATCH in 1 CARTON (35356-062-05)  > 72 h in 1 PATCH",
      "NDC11Code": "35356-0062-05",
      "ProductNDC": "35356-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fentanyl",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20130109",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076258",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "12",
      "StrengthUnit": "ug/h",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.",
      "Description": "Fentanyl transdermal system is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4. System Components and Structure. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 6.25 cm2). The composition per unit area of all system sizes is identical. Fentanyl transdermal system is a transparent rectangular patch with rounded corners comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyolefin film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
    },
    {
      "NDCCode": "47335-062-79",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (47335-062-79)  / 10 CAPSULE in 1 BLISTER PACK (47335-062-66) ",
      "NDC11Code": "47335-0062-79",
      "ProductNDC": "47335-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dofetilide",
      "NonProprietaryName": "Dofetilide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181011",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210466",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "DOFETILIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181011",
      "SamplePackage": "N",
      "IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence). Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter. Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
      "Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide, USP is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: silicified microcrystalline cellulose, corn starch and magnesium stearate. The components of the hard gelatin capsule shell include gelatin, FD&C Yellow 6 and titanium dioxide. Black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. Dofetilide capsule is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
    },
    {
      "NDCCode": "47335-062-86",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (47335-062-86) ",
      "NDC11Code": "47335-0062-86",
      "ProductNDC": "47335-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dofetilide",
      "NonProprietaryName": "Dofetilide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181011",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210466",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "DOFETILIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181011",
      "SamplePackage": "N",
      "IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence). Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter. Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
      "Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide, USP is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: silicified microcrystalline cellulose, corn starch and magnesium stearate. The components of the hard gelatin capsule shell include gelatin, FD&C Yellow 6 and titanium dioxide. Black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. Dofetilide capsule is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
    },
    {
      "NDCCode": "49738-062-08",
      "PackageDescription": "8 BLISTER PACK in 1 CARTON (49738-062-08)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "49738-0062-08",
      "ProductNDC": "49738-062",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Motion Sickness Relief",
      "ProprietaryNameSuffix": "Less Drowsy",
      "NonProprietaryName": "Meclizine Hcl",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140228",
      "EndMarketingDate": "20181231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part336",
      "LabelerName": "SMART SENSE (Kmart)",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140228",
      "EndMarketingDatePackage": "20181231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50242-062-01",
      "PackageDescription": "30 TABLET in 1 BOTTLE (50242-062-01) ",
      "NDC11Code": "50242-0062-01",
      "ProductNDC": "50242-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tarceva",
      "NonProprietaryName": "Erlotinib Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021743",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "ERLOTINIB HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20050430",
      "SamplePackage": "N",
      "IndicationAndUsage": "TARCEVA is a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).",
      "Description": "TARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. TARCEVA tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: lactose monohydrate, hypromellose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate and titanium dioxide. The tablets also contain trace amounts of color additives, including FD&C Yellow #6 (25 mg only) for product identification."
    },
    {
      "NDCCode": "50268-062-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50268-062-15)  / 1 TABLET in 1 BLISTER PACK (50268-062-11) ",
      "NDC11Code": "50268-0062-15",
      "ProductNDC": "50268-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075382",
      "LabelerName": "AvPAK",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140718",
      "SamplePackage": "N",
      "IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
      "Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9- dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
    }
  ]
}
                    

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  <NDC>
    <NDCCode>57469-062-25</NDCCode>
    <PackageDescription>25 PATCH in 1 POUCH (57469-062-25)  &gt; 1.3 g in 1 PATCH</PackageDescription>
    <NDC11Code>57469-0062-25</NDC11Code>
    <ProductNDC>57469-062</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disney Planes Fire And Rescue Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
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    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140508</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Bolero Home Decor, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>57469-057-25</NDCCode>
    <PackageDescription>25 PATCH in 1 POUCH (57469-057-25)  &gt; 1.3 g in 1 PATCH</PackageDescription>
    <NDC11Code>57469-0057-25</NDC11Code>
    <ProductNDC>57469-057</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disney Princess Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Bolero Home Decor, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
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    <StrengthUnit>g/100g</StrengthUnit>
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    <LastUpdate>2016-12-02</LastUpdate>
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  <NDC>
    <NDCCode>57469-058-25</NDCCode>
    <PackageDescription>25 PATCH in 1 POUCH (57469-058-25)  &gt; 1.3 g in 1 PATCH</PackageDescription>
    <NDC11Code>57469-0058-25</NDC11Code>
    <ProductNDC>57469-058</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disney Minnie Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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    <LabelerName>Bolero Home Decor, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
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  <NDC>
    <NDCCode>57469-059-25</NDCCode>
    <PackageDescription>25 PATCH in 1 POUCH (57469-059-25)  &gt; 1.3 g in 1 PATCH</PackageDescription>
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    <ProductNDC>57469-059</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disney Fairies Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Bolero Home Decor, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
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  <NDC>
    <NDCCode>57469-060-25</NDCCode>
    <PackageDescription>25 PATCH in 1 POUCH (57469-060-25)  &gt; 1.3 g in 1 PATCH</PackageDescription>
    <NDC11Code>57469-0060-25</NDC11Code>
    <ProductNDC>57469-060</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disney Frozen Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140508</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Bolero Home Decor, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>57469-061-25</NDCCode>
    <PackageDescription>25 PATCH in 1 POUCH (57469-061-25)  &gt; 1.3 g in 1 PATCH</PackageDescription>
    <NDC11Code>57469-0061-25</NDC11Code>
    <ProductNDC>57469-061</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Marvel Ultimate Spider-man Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Bolero Home Decor, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>57469-063-25</NDCCode>
    <PackageDescription>25 PATCH in 1 POUCH (57469-063-25)  &gt; 1.3 g in 1 PATCH</PackageDescription>
    <NDC11Code>57469-0063-25</NDC11Code>
    <ProductNDC>57469-063</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Disney Pixar Cars Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Bolero Home Decor, Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10738-062-20</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10738-062-20)  / 62 g in 1 TUBE (10738-062-25) </PackageDescription>
    <NDC11Code>10738-0062-20</NDC11Code>
    <ProductNDC>10738-062</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triderma Psoriasis Control Face And Body Cream</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191230</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Genuine Virgin Aloe Corporation</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <IndicationAndUsage>Uses relieves and helps prevent recurrence of: itching irritation redness flaking  scaling due to psoriasis and seborrheic dermatitis.</IndicationAndUsage>
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    <NDCCode>42765-062-25</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (42765-062-25) </PackageDescription>
    <NDC11Code>42765-0062-25</NDC11Code>
    <ProductNDC>42765-062</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dexlansoprazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230701</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Metrochem API Private Limited</LabelerName>
    <SubstanceName>DEXLANSOPRAZOLE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/25kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-02-01</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>63934-062-01</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (63934-062-01)</PackageDescription>
    <NDC11Code>63934-0062-01</NDC11Code>
    <ProductNDC>63934-062</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170822</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Kumar Organic Products Limited</LabelerName>
    <SubstanceName>4-BUTYLRESORCINOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70069-062-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (70069-062-25)  / 20 mL in 1 VIAL (70069-062-01) </PackageDescription>
    <NDC11Code>70069-0062-25</NDC11Code>
    <ProductNDC>70069-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20180615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207636</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropivacaine hydrochloride injection 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>Ropivacaine hydrochloride injection, USP 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. Ropivacaine hydrochloride injection, USP 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. Ropivacaine hydrochloride injection, USP 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 mg, 5 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 ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
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    <NDCCode>72572-062-25</NDCCode>
    <PackageDescription>25 VIAL in 1 BOX (72572-062-25)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72572-062-01) </PackageDescription>
    <NDC11Code>72572-0062-25</NDC11Code>
    <ProductNDC>72572-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ceftriaxone</ProprietaryName>
    <NonProprietaryName>Ceftriaxone</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20200301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065342</ApplicationNumber>
    <LabelerName>Civica, Inc.</LabelerName>
    <SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for 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. Ceftriaxone for Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms. LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta‑lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of Ceftriaxone for Injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose of Ceftriaxone for Injection, USP and the comparator. The potentially lower clinical cure rate of Ceftriaxone for Injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii1, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis1 or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase‑producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for Injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for Injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis1 and Escherichia coli.1. 1Efficacy for this organism in this organ system was studied in fewer than ten infections.</IndicationAndUsage>
    <Description>Ceftriaxone for Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.59 and the following structural formula. Ceftriaxone for Injection, USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.</Description>
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    <NDCCode>73025-062-25</NDCCode>
    <PackageDescription>250 mL in 1 BOTTLE, PLASTIC (73025-062-25) </PackageDescription>
    <NDC11Code>73025-0062-25</NDC11Code>
    <ProductNDC>73025-062</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Spatherapy Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Shalom International Corp</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.62</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73569-062-04</NDCCode>
    <PackageDescription>25 g in 1 BOTTLE (73569-062-04) </PackageDescription>
    <NDC11Code>73569-0062-04</NDC11Code>
    <ProductNDC>73569-062</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Hexarelin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20241209</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Peptites Biotech</LabelerName>
    <SubstanceName>EXAMORELIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-DEC-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>73687-062-25</NDCCode>
    <PackageDescription>15 AMPULE in 1 CARTON (73687-062-25)  / .3 mL in 1 AMPULE (73687-062-80) </PackageDescription>
    <NDC11Code>73687-0062-25</NDC11Code>
    <ProductNDC>73687-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Upneeq</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride Ophthalmic</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20200821</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212520</ApplicationNumber>
    <LabelerName>RVL Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200821</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults.</IndicationAndUsage>
    <Description>UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% contains oxymetazoline hydrochloride, an alpha adrenoceptor agonist. UPNEEQ is an aseptically prepared, sterile, non-preserved ophthalmic solution. The chemical name is 6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4- dimethylphenol monohydrochloride, and the molecular mass is 296.84. Oxymetazoline HCl is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water. The molecular formula of oxymetazoline HCl is C16H24N2O∙HCl, and its structural formula is. Each mL of UPNEEQ (oxymetazoline hydrochloride ophthalmic solution) 0.1% contains 1 mg of oxymetazoline hydrochloride, equivalent to 0.9 mg (0.09%) of oxymetazoline free base. The ophthalmic solution contains the following inactive ingredients: calcium chloride, hydrochloric acid (used to adjust pH to 5.8 to 6.8), hypromellose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>75839-062-25</NDCCode>
    <PackageDescription>25 g in 1 BOTTLE (75839-062-25)</PackageDescription>
    <NDC11Code>75839-0062-25</NDC11Code>
    <ProductNDC>75839-062</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Trilostane</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130411</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
    <LabelerName>Attix Pharmaceuticals</LabelerName>
    <SubstanceName>TRILOSTANE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>83324-062-25</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (83324-062-25)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>83324-0062-25</NDC11Code>
    <ProductNDC>83324-062</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Flu Hbp</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260217</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Chain Drug Marketing Association, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>325; 2; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these common cold and flu symptoms: minor aches and painssore throatsneezingheadacherunny nosecough. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11489-062-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (11489-062-01)  &gt; 50 mL in 1 JAR</PackageDescription>
    <NDC11Code>11489-0062-01</NDC11Code>
    <ProductNDC>11489-062</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>No7 Time Resisting Day Sunscreen Spf 12</ProprietaryName>
    <NonProprietaryName>Octinoxate And Avobenzone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091208</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>BCM Ltd</LabelerName>
    <SubstanceName>OCTINOXATE; AVOBENZONE</SubstanceName>
    <StrengthNumber>2.5; 1.25</StrengthNumber>
    <StrengthUnit>mL/50mL; mL/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13107-062-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (13107-062-01)</PackageDescription>
    <NDC11Code>13107-0062-01</NDC11Code>
    <ProductNDC>13107-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Tartrate</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077739</ApplicationNumber>
    <LabelerName>Aurolife Pharma LLC</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <Description>The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&amp;C Red #30 Aluminium Lake and 100 mg tablet contains FD&amp;C Blue #2 Aluminium Lake as coloring agents.</Description>
  </NDC>
  <NDC>
    <NDCCode>13107-062-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (13107-062-99)</PackageDescription>
    <NDC11Code>13107-0062-99</NDC11Code>
    <ProductNDC>13107-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Tartrate</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077739</ApplicationNumber>
    <LabelerName>Aurolife Pharma LLC</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <Description>The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&amp;C Red #30 Aluminium Lake and 100 mg tablet contains FD&amp;C Blue #2 Aluminium Lake as coloring agents.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-062-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-062-04)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0062-04</NDC11Code>
    <ProductNDC>21922-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208848</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-062-05</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-062-05)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0062-05</NDC11Code>
    <ProductNDC>21922-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208848</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-062-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-062-15)  / 80 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0062-15</NDC11Code>
    <ProductNDC>21922-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208848</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-062-30</NDCCode>
    <PackageDescription>454 g in 1 JAR (21922-062-30) </PackageDescription>
    <NDC11Code>21922-0062-30</NDC11Code>
    <ProductNDC>21922-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208848</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-062-05</NDCCode>
    <PackageDescription>5 PATCH in 1 CARTON (35356-062-05)  &gt; 72 h in 1 PATCH</PackageDescription>
    <NDC11Code>35356-0062-05</NDC11Code>
    <ProductNDC>35356-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fentanyl</ProprietaryName>
    <NonProprietaryName>Fentanyl</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20130109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076258</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>FENTANYL</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>ug/h</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.</IndicationAndUsage>
    <Description>Fentanyl transdermal system is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4. System Components and Structure. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 6.25 cm2). The composition per unit area of all system sizes is identical. Fentanyl transdermal system is a transparent rectangular patch with rounded corners comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyolefin film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
  </NDC>
  <NDC>
    <NDCCode>47335-062-79</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (47335-062-79)  / 10 CAPSULE in 1 BLISTER PACK (47335-062-66) </PackageDescription>
    <NDC11Code>47335-0062-79</NDC11Code>
    <ProductNDC>47335-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dofetilide</ProprietaryName>
    <NonProprietaryName>Dofetilide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181011</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210466</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>DOFETILIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181011</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence). Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter. Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
    <Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide, USP is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: silicified microcrystalline cellulose, corn starch and magnesium stearate. The components of the hard gelatin capsule shell include gelatin, FD&amp;C Yellow 6 and titanium dioxide. Black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. Dofetilide capsule is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
  </NDC>
  <NDC>
    <NDCCode>47335-062-86</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (47335-062-86) </PackageDescription>
    <NDC11Code>47335-0062-86</NDC11Code>
    <ProductNDC>47335-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dofetilide</ProprietaryName>
    <NonProprietaryName>Dofetilide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181011</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210466</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>DOFETILIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181011</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence). Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter. Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
    <Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide, USP is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: silicified microcrystalline cellulose, corn starch and magnesium stearate. The components of the hard gelatin capsule shell include gelatin, FD&amp;C Yellow 6 and titanium dioxide. Black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. Dofetilide capsule is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
  </NDC>
  <NDC>
    <NDCCode>49738-062-08</NDCCode>
    <PackageDescription>8 BLISTER PACK in 1 CARTON (49738-062-08)  &gt; 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>49738-0062-08</NDC11Code>
    <ProductNDC>49738-062</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Motion Sickness Relief</ProprietaryName>
    <ProprietaryNameSuffix>Less Drowsy</ProprietaryNameSuffix>
    <NonProprietaryName>Meclizine Hcl</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140228</StartMarketingDate>
    <EndMarketingDate>20181231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part336</ApplicationNumber>
    <LabelerName>SMART SENSE (Kmart)</LabelerName>
    <SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140228</StartMarketingDatePackage>
    <EndMarketingDatePackage>20181231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50242-062-01</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (50242-062-01) </PackageDescription>
    <NDC11Code>50242-0062-01</NDC11Code>
    <ProductNDC>50242-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tarceva</ProprietaryName>
    <NonProprietaryName>Erlotinib Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050430</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021743</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <SubstanceName>ERLOTINIB HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TARCEVA is a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).</IndicationAndUsage>
    <Description>TARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. TARCEVA tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: lactose monohydrate, hypromellose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate and titanium dioxide. The tablets also contain trace amounts of color additives, including FD&amp;C Yellow #6 (25 mg only) for product identification.</Description>
  </NDC>
  <NDC>
    <NDCCode>50268-062-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50268-062-15)  / 1 TABLET in 1 BLISTER PACK (50268-062-11) </PackageDescription>
    <NDC11Code>50268-0062-15</NDC11Code>
    <ProductNDC>50268-062</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140718</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075382</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
    <Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9- dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>57469-062-25</NDCCode><ProprietaryName>Disney Planes Fire And Rescue Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>57469-057-25</NDCCode><ProprietaryName>Disney Princess Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>57469-058-25</NDCCode><ProprietaryName>Disney Minnie Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>57469-059-25</NDCCode><ProprietaryName>Disney Fairies Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>57469-060-25</NDCCode><ProprietaryName>Disney Frozen Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>57469-061-25</NDCCode><ProprietaryName>Marvel Ultimate Spider-man Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>57469-063-25</NDCCode><ProprietaryName>Disney Pixar Cars Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>10738-062-20</NDCCode><ProprietaryName>Triderma Psoriasis Control Face And Body Cream</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>42765-062-25</NDCCode><NonProprietaryName>Dexlansoprazole</NonProprietaryName></NDC><NDC><NDCCode>63934-062-01</NDCCode><NonProprietaryName>Benzethonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>70069-062-25</NDCCode><ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72572-062-25</NDCCode><ProprietaryName>Ceftriaxone</ProprietaryName><NonProprietaryName>Ceftriaxone</NonProprietaryName></NDC><NDC><NDCCode>73025-062-25</NDCCode><ProprietaryName>Spatherapy Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>73569-062-04</NDCCode><NonProprietaryName>Hexarelin</NonProprietaryName></NDC><NDC><NDCCode>73687-062-25</NDCCode><ProprietaryName>Upneeq</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride Ophthalmic</NonProprietaryName></NDC><NDC><NDCCode>75839-062-25</NDCCode><NonProprietaryName>Trilostane</NonProprietaryName></NDC><NDC><NDCCode>83324-062-25</NDCCode><ProprietaryName>Flu Hbp</ProprietaryName><NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr</NonProprietaryName></NDC><NDC><NDCCode>11489-062-01</NDCCode><ProprietaryName>No7 Time Resisting Day Sunscreen Spf 12</ProprietaryName><NonProprietaryName>Octinoxate And Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>13107-062-01</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>13107-062-99</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>21922-062-04</NDCCode><ProprietaryName>Triamcinolone Acetonide</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>21922-062-05</NDCCode><ProprietaryName>Triamcinolone Acetonide</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>21922-062-15</NDCCode><ProprietaryName>Triamcinolone Acetonide</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>21922-062-30</NDCCode><ProprietaryName>Triamcinolone Acetonide</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>35356-062-05</NDCCode><ProprietaryName>Fentanyl</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>47335-062-79</NDCCode><ProprietaryName>Dofetilide</ProprietaryName><NonProprietaryName>Dofetilide</NonProprietaryName></NDC><NDC><NDCCode>47335-062-86</NDCCode><ProprietaryName>Dofetilide</ProprietaryName><NonProprietaryName>Dofetilide</NonProprietaryName></NDC><NDC><NDCCode>49738-062-08</NDCCode><ProprietaryName>Motion Sickness Relief</ProprietaryName><NonProprietaryName>Meclizine Hcl</NonProprietaryName></NDC><NDC><NDCCode>50242-062-01</NDCCode><ProprietaryName>Tarceva</ProprietaryName><NonProprietaryName>Erlotinib Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50268-062-15</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</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",
      "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."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
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      "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",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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