RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (33 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0280-0083-01",
      "PackageDescription": "18 PACKET in 1 CARTON (0280-0083-01)  / 2 TABLET, EFFERVESCENT in 1 PACKET",
      "NDC11Code": "00280-0083-01",
      "ProductNDC": "0280-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alka-seltzer Heartburn Relief Lemon Lime",
      "NonProprietaryName": "Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "Bayer Healthcare LLC",
      "SubstanceName": "SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE",
      "StrengthNumber": "1650; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220216",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses for the relief of : 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
    },
    {
      "NDCCode": "0280-0083-02",
      "PackageDescription": "12 PACKET in 1 CARTON (0280-0083-02)  / 2 TABLET, EFFERVESCENT in 1 PACKET",
      "NDC11Code": "00280-0083-02",
      "ProductNDC": "0280-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alka-seltzer Heartburn Relief Lemon Lime",
      "NonProprietaryName": "Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "Bayer Healthcare LLC",
      "SubstanceName": "SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE",
      "StrengthNumber": "1650; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses for the relief of : 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
    },
    {
      "NDCCode": "0280-0083-03",
      "PackageDescription": "36 PACKET in 1 CARTON (0280-0083-03)  / 2 TABLET, EFFERVESCENT in 1 PACKET",
      "NDC11Code": "00280-0083-03",
      "ProductNDC": "0280-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alka-seltzer Heartburn Relief Lemon Lime",
      "NonProprietaryName": "Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M001",
      "LabelerName": "Bayer Healthcare LLC",
      "SubstanceName": "SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE",
      "StrengthNumber": "1650; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses for the relief of : 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
    },
    {
      "NDCCode": "0360-0083-01",
      "PackageDescription": "1 g in 1 BOTTLE, PLASTIC (0360-0083-01) ",
      "NDC11Code": "00360-0083-01",
      "ProductNDC": "0360-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calcarea Fluorica",
      "NonProprietaryName": "Calc Fluor",
      "DosageFormName": "TABLET",
      "RouteName": "SUBLINGUAL",
      "StartMarketingDate": "19970217",
      "EndMarketingDate": "20200101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "STANDARD HOMEOPATHIC COMPANY",
      "SubstanceName": "CALCIUM FLUORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_X]/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19970217",
      "EndMarketingDatePackage": "20200101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0378-0083-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0083-01) ",
      "NDC11Code": "00378-0083-01",
      "ProductNDC": "0378-0083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Captopril And Hydrochlorothiazide",
      "NonProprietaryName": "Captopril And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19971229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074896",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "CAPTOPRIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "19971229",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11014-0083-1",
      "PackageDescription": "1 BAG in 1 CONTAINER (11014-0083-1)  > 1000000 CAPSULE, EXTENDED RELEASE in 1 BAG",
      "NDC11Code": "11014-0083-01",
      "ProductNDC": "11014-0083",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "StartMarketingDate": "20120103",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Catalent Pharma Solutions, LLC",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "03-JAN-12"
    },
    {
      "NDCCode": "11489-083-01",
      "PackageDescription": "1 JAR in 1 CARTON (11489-083-01)  > 50 g in 1 JAR",
      "NDC11Code": "11489-0083-01",
      "ProductNDC": "11489-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Botanics Protecting Day Age Defense Sunscreen Broad Spectrum Spf 15",
      "NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130114",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "BCM Ltd",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "1.5; 1.5; 2.5",
      "StrengthUnit": "g/50g; g/50g; g/50g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses."
    },
    {
      "NDCCode": "12090-0083-1",
      "PackageDescription": "1 TUBE in 1 CARTON (12090-0083-1)  > 250 mL in 1 TUBE",
      "NDC11Code": "12090-0083-01",
      "ProductNDC": "12090-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lantiseptic Protective",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160330",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Santus LLC",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "430",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-31",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "12634-083-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (12634-083-01)",
      "NDC11Code": "12634-0083-01",
      "ProductNDC": "12634-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090278",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1) , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (  1.2)  .",
      "Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate  tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-­Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
    },
    {
      "NDCCode": "12828-0083-1",
      "PackageDescription": "10 kg in 1 DRUM (12828-0083-1) ",
      "NDC11Code": "12828-0083-01",
      "ProductNDC": "12828-0083",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Epinephrine Bitartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140603",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Cambrex Profarmaco Milano Srl",
      "SubstanceName": "EPINEPHRINE BITARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-05-22",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "03-JUN-14"
    },
    {
      "NDCCode": "13107-083-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13107-083-01) ",
      "NDC11Code": "13107-0083-01",
      "ProductNDC": "13107-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lorazepam",
      "NonProprietaryName": "Lorazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203572",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "LORAZEPAM",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
      "Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
    },
    {
      "NDCCode": "13668-083-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13668-083-01) ",
      "NDC11Code": "13668-0083-01",
      "ProductNDC": "13668-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090722",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20110620",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "15631-0083-1",
      "PackageDescription": "200 PELLET in 1 PACKAGE (15631-0083-1) ",
      "NDC11Code": "15631-0083-01",
      "ProductNDC": "15631-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blatta Orientalis",
      "NonProprietaryName": "Blatta Orientalis",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150912",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "BLATTA ORIENTALIS",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "16714-083-01",
      "PackageDescription": "30 TABLET in 1 BOTTLE (16714-083-01)",
      "NDC11Code": "16714-0083-01",
      "ProductNDC": "16714-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Hydrochloride",
      "NonProprietaryName": "Hydroxyzine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040840",
      "LabelerName": "Northstar RxLLC",
      "SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "17337-0083-1",
      "PackageDescription": "1 BAG in 1 DRUM (17337-0083-1)  > 1 BAG in 1 BAG > 20 kg in 1 BAG",
      "NDC11Code": "17337-0083-01",
      "ProductNDC": "17337-0083",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Isotretinoin Micronized",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170901",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Olon S.p.A.",
      "SubstanceName": "ISOTRETINOIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2017-12-20",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "17856-0083-1",
      "PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-1)  / 5 mL in 1 CUP, UNIT-DOSE (17856-0083-4) ",
      "NDC11Code": "17856-0083-01",
      "ProductNDC": "17856-0083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020903",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074738",
      "LabelerName": "ATLANTIC BIOLOGICALS CORP.",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/5mL",
      "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": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240416",
      "SamplePackage": "N",
      "IndicationAndUsage": "Herpes Zoster Infections:Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir is indicated for the treatment of chickenpox (varicella).",
      "Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir suspension is formulated for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension USP contains 200 mg of acyclovir and the inactive ingredients carboxymethylcellulose sodium, flavor, glycerin, methylparaben (0.1%), microcrystalline cellulose, propylparaben (0.02%), purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3, and a molecular weight of 225.20. 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 9-[(2-Hydroxyethoxy)methyl]guanine; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitroand in vivoinhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in three ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities:The quantitative relationship between the in vitrosusceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50of 1.35 mcg/mL. Drug Resistance:Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
    },
    {
      "NDCCode": "21565-0083-1",
      "PackageDescription": "1 kg in 1 DRUM (21565-0083-1)",
      "NDC11Code": "21565-0083-01",
      "ProductNDC": "21565-0083",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Mebrofenin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20020701",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Sigma-Aldrich Corporation",
      "SubstanceName": "MEBROFENIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "27808-083-01",
      "PackageDescription": "1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-083-01)  > 100 mL in 1 BOTTLE, UNIT-DOSE",
      "NDC11Code": "27808-0083-01",
      "ProductNDC": "27808-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "ProprietaryNameSuffix": "Solution",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203519",
      "LabelerName": "Tris Pharma Inc",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "37662-0083-1",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0083-1) ",
      "NDC11Code": "37662-0083-01",
      "ProductNDC": "37662-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calcarea Fluorica",
      "NonProprietaryName": "Calcarea Fluorica",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220518",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CALCIUM FLUORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_Q]/1",
      "Status": "Active",
      "LastUpdate": "2022-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220518",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "41190-083-01",
      "PackageDescription": "1 TUBE in 1 CARTON (41190-083-01)  > 15 g in 1 TUBE",
      "NDC11Code": "41190-0083-01",
      "ProductNDC": "41190-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shoprite",
      "NonProprietaryName": "Terbinafine Hydrochloride",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20070702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077511",
      "LabelerName": "WAKEFERN FOOD CORPORATION",
      "SubstanceName": "TERBINAFINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "cures most athlete's foot (tinea pedis). cures most jock itch (tinea cruris) and ringworm (tinea corporis). relieves itching, burning, cracking and scaling which accompany these conditions."
    },
    {
      "NDCCode": "41366-083-01",
      "PackageDescription": "45 mL in 1 BOTTLE (41366-083-01) ",
      "NDC11Code": "41366-0083-01",
      "ProductNDC": "41366-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cherry Blossom Pear Hand Sanitizer",
      "NonProprietaryName": "Cherry Blossom Pear Hand Sanitizer",
      "DosageFormName": "LIQUID",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20250610",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Zhejiang Meimi Technology Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that may cause disease."
    },
    {
      "NDCCode": "42224-0083-1",
      "PackageDescription": "10 kg in 1 DRUM (42224-0083-1)",
      "NDC11Code": "42224-0083-01",
      "ProductNDC": "42224-0083",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cyclandelate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20141104",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Ancheng Pharma Limited",
      "SubstanceName": "CYCLANDELATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "42227-083-01",
      "PackageDescription": "1 KIT in 1 CARTON (42227-083-01)  *  5 mL in 1 VIAL, SINGLE-USE (42227-081-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) ",
      "NDC11Code": "42227-0083-01",
      "ProductNDC": "42227-083",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Cinryze",
      "NonProprietaryName": "Human C1-esterase Inhibitor",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20210115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125267",
      "LabelerName": "Takeda Pharmaceuticals America, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210115",
      "SamplePackage": "N",
      "IndicationAndUsage": "CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE).",
      "Description": "CINRYZE (C1 esterase inhibitor [human]) (Freeze-Dried Powder for Reconstitution) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. CINRYZE potency is expressed by its C1 esterase inhibitor activity measured with a validated chromogenic assay. The potency of C1 esterase inhibitor is expressed in International Units (IU), which is related to the current WHO standard for C1 esterase inhibitor products. One International Unit (IU) corresponds to the amount of C1 esterase inhibitor present in 1 mL of normal plasma. The specific activity of CINRYZE is 4.0 to 9.0 U/mg protein. The purity is ≥90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 IU of functionally active C1 esterase inhibitor, pH 6.6 to 7.4, and an osmolality between 200 to 400 mosmol/kg. CINRYZE, when reconstituted with 5 mL of Sterile Water for Injection, USP contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine. The following manufacturing steps are designed to reduce the risk of viral transmission: 1 Screening donors at U.S. licensed blood collection centers to rule out infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus, or Hepatitis C Virus., 2 Testing plasma pools by in-process NAT for parvovirus B19 via minipool testing and the limit of B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL., 3 Use of two independent viral reduction steps in the manufacture of CINRYZE: pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers) and nano filtration through two sequential 15 nm filters."
    },
    {
      "NDCCode": "42731-083-01",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (42731-083-01) ",
      "NDC11Code": "42731-0083-01",
      "ProductNDC": "42731-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triple Flu Defense",
      "NonProprietaryName": "Aconitum Napellus, Anas Barbariae, Hepatis Et Cordis Extractum, Antimonium Crudum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Influenzinum, Ipecacuanha, Kali Bichromicum, Nux Vomica, Phosphorus, Phytolacca Decandra",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251125",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Nenningers Naturals, LLC",
      "SubstanceName": "ACONITUM NAPELLUS WHOLE; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLE; INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLE; IPECAC; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT",
      "StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
      "StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Reduce duration and severity of flu-like symptoms.*. *This product has not been tested or the uses evaluated by the FDA."
    },
    {
      "NDCCode": "42806-083-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (42806-083-01) ",
      "NDC11Code": "42806-0083-01",
      "ProductNDC": "42806-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Buspirone Hydrochloride",
      "NonProprietaryName": "Buspirone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190417",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208972",
      "LabelerName": "Epic Pharma, LLC",
      "SubstanceName": "BUSPIRONE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2019-04-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190417",
      "SamplePackage": "N",
      "IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
      "Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
    },
    {
      "NDCCode": "43742-0083-1",
      "PackageDescription": "960 mL in 1 BOTTLE (43742-0083-1)",
      "NDC11Code": "43742-0083-01",
      "ProductNDC": "43742-0083",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Coxsackie A2, A7, B1, B3, B4",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20120921",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Deseret Biologicals, Inc.",
      "SubstanceName": "HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B3",
      "StrengthNumber": "500; 500; 500; 500; 500",
      "StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
      "Status": "Unfinished",
      "LastUpdate": "2017-12-20",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "43846-0083-1",
      "PackageDescription": "57 g in 1 TUBE (43846-0083-1) ",
      "NDC11Code": "43846-0083-01",
      "ProductNDC": "43846-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Muscle Rescue",
      "NonProprietaryName": "Arnica Montana, Rhus Tox, Phytolacca Decandra, Pulsatilla (vulgaris), Ruta Graveolens",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240611",
      "EndMarketingDate": "20300605",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Peaceful Mountain, Inc.",
      "SubstanceName": "ARNICA MONTANA WHOLE; TOXICODENDRON PUBESCENS LEAF; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS WHOLE; RUTA GRAVEOLENS FLOWERING TOP",
      "StrengthNumber": "3; 4; 12; 12; 12",
      "StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
      "Status": "Active",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240611",
      "EndMarketingDatePackage": "20300605",
      "SamplePackage": "N",
      "IndicationAndUsage": "May temporarily relieve minor symptoms of muscle aches, pains from overexertion, and injury.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
    },
    {
      "NDCCode": "43857-0083-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43857-0083-1) ",
      "NDC11Code": "43857-0083-01",
      "ProductNDC": "43857-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bronchiforce",
      "NonProprietaryName": "Althaea Officinalis, Lobelia Inflata, Rheum (officinale), Verbascum Thapsus, Belladonna, Cuprum Aceticum, Drosera (rotundifolia), Ipecacuanha, Spongia Tosta, Sticta Pulmonaria",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130213",
      "EndMarketingDate": "20241112",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "BioActive Nutritional, Inc.",
      "SubstanceName": "ALTHAEA OFFICINALIS ROOT; ATROPA BELLADONNA WHOLE; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; LOBELIA INFLATA; RHEUM OFFICINALE ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS",
      "StrengthNumber": "3; 12; 12; 12; 12; 12; 3; 3; 12; 3",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140209",
      "EndMarketingDatePackage": "20241112",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of tickling, short dry cough that is worse at night, barking cough with expectoration, cough very deep, and hoarseness after midnight."
    },
    {
      "NDCCode": "44717-083-01",
      "PackageDescription": "30 mL in 1 BOTTLE (44717-083-01) ",
      "NDC11Code": "44717-0083-01",
      "ProductNDC": "44717-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Illuminizing Blendrops Broad Spectrum Spf 40",
      "NonProprietaryName": "Homosalate, Octisalate, Zinc Oxide",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240202",
      "EndMarketingDate": "20270228",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Wasatch Product Development, LLC",
      "SubstanceName": "OCTISALATE; HOMOSALATE; ZINC OXIDE",
      "StrengthNumber": "5; 6; 12",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240202",
      "EndMarketingDatePackage": "20270228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
    },
    {
      "NDCCode": "44911-0083-1",
      "PackageDescription": "60 mL in 1 BOTTLE, DROPPER (44911-0083-1)",
      "NDC11Code": "44911-0083-01",
      "ProductNDC": "44911-0083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Infectistat",
      "NonProprietaryName": "Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra, Symphytum Officinale, Lung (suis), Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia, Causticum, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Natrum Sulphuricum, Phosphorus, Pulsatilla, Rhus Toxicodendron, Silicea, Sulphur, Pyrogenium",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130501",
      "EndMarketingDate": "20201103",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Energique, Inc.",
      "SubstanceName": "BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; SUS SCROFA LUNG; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF",
      "StrengthNumber": "3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-04",
      "ProductNdcExcludeFlag": "N"
    }
  ]
}
                    

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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calcarea Fluorica</ProprietaryName>
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    <LabelerName>STANDARD HOMEOPATHIC COMPANY</LabelerName>
    <SubstanceName>CALCIUM FLUORIDE</SubstanceName>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <ApplicationNumber>ANDA074896</ApplicationNumber>
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    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
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    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
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    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
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    <DEASchedule>CII</DEASchedule>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Botanics Protecting Day Age Defense Sunscreen Broad Spectrum Spf 15</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
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    <IndicationAndUsage>Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lantiseptic Protective</ProprietaryName>
    <NonProprietaryName>Petrolatum</NonProprietaryName>
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    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Santus LLC</LabelerName>
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    <LastUpdate>2020-01-31</LastUpdate>
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    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <LabelerName>Cambrex Profarmaco Milano Srl</LabelerName>
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    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203572</ApplicationNumber>
    <LabelerName>Aurolife Pharma LLC</LabelerName>
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    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
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    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
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    <ProductNDC>13668-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090722</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>15631-0083-1</NDCCode>
    <PackageDescription>200 PELLET in 1 PACKAGE (15631-0083-1) </PackageDescription>
    <NDC11Code>15631-0083-01</NDC11Code>
    <ProductNDC>15631-0083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Blatta Orientalis</ProprietaryName>
    <NonProprietaryName>Blatta Orientalis</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150912</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>BLATTA ORIENTALIS</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-083-01</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (16714-083-01)</PackageDescription>
    <NDC11Code>16714-0083-01</NDC11Code>
    <ProductNDC>16714-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040840</ApplicationNumber>
    <LabelerName>Northstar RxLLC</LabelerName>
    <SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>17337-0083-1</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (17337-0083-1)  &gt; 1 BAG in 1 BAG &gt; 20 kg in 1 BAG</PackageDescription>
    <NDC11Code>17337-0083-01</NDC11Code>
    <ProductNDC>17337-0083</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Isotretinoin Micronized</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Olon S.p.A.</LabelerName>
    <SubstanceName>ISOTRETINOIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>17856-0083-1</NDCCode>
    <PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-1)  / 5 mL in 1 CUP, UNIT-DOSE (17856-0083-4) </PackageDescription>
    <NDC11Code>17856-0083-01</NDC11Code>
    <ProductNDC>17856-0083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020903</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074738</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</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>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections:Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir suspension is formulated for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension USP contains 200 mg of acyclovir and the inactive ingredients carboxymethylcellulose sodium, flavor, glycerin, methylparaben (0.1%), microcrystalline cellulose, propylparaben (0.02%), purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3, and a molecular weight of 225.20. 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 9-[(2-Hydroxyethoxy)methyl]guanine; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitroand in vivoinhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in three ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities:The quantitative relationship between the in vitrosusceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50of 1.35 mcg/mL. Drug Resistance:Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
  </NDC>
  <NDC>
    <NDCCode>21565-0083-1</NDCCode>
    <PackageDescription>1 kg in 1 DRUM (21565-0083-1)</PackageDescription>
    <NDC11Code>21565-0083-01</NDC11Code>
    <ProductNDC>21565-0083</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Mebrofenin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20020701</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Sigma-Aldrich Corporation</LabelerName>
    <SubstanceName>MEBROFENIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>27808-083-01</NDCCode>
    <PackageDescription>1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-083-01)  &gt; 100 mL in 1 BOTTLE, UNIT-DOSE</PackageDescription>
    <NDC11Code>27808-0083-01</NDC11Code>
    <ProductNDC>27808-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <ProprietaryNameSuffix>Solution</ProprietaryNameSuffix>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203519</ApplicationNumber>
    <LabelerName>Tris Pharma Inc</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>37662-0083-1</NDCCode>
    <PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0083-1) </PackageDescription>
    <NDC11Code>37662-0083-01</NDC11Code>
    <ProductNDC>37662-0083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calcarea Fluorica</ProprietaryName>
    <NonProprietaryName>Calcarea Fluorica</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220518</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>CALCIUM FLUORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_Q]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>41190-083-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (41190-083-01)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>41190-0083-01</NDC11Code>
    <ProductNDC>41190-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shoprite</ProprietaryName>
    <NonProprietaryName>Terbinafine Hydrochloride</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20070702</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077511</ApplicationNumber>
    <LabelerName>WAKEFERN FOOD CORPORATION</LabelerName>
    <SubstanceName>TERBINAFINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>cures most athlete's foot (tinea pedis). cures most jock itch (tinea cruris) and ringworm (tinea corporis). relieves itching, burning, cracking and scaling which accompany these conditions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41366-083-01</NDCCode>
    <PackageDescription>45 mL in 1 BOTTLE (41366-083-01) </PackageDescription>
    <NDC11Code>41366-0083-01</NDC11Code>
    <ProductNDC>41366-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cherry Blossom Pear Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Cherry Blossom Pear Hand Sanitizer</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20250610</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Zhejiang Meimi Technology Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that may cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42224-0083-1</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42224-0083-1)</PackageDescription>
    <NDC11Code>42224-0083-01</NDC11Code>
    <ProductNDC>42224-0083</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cyclandelate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20141104</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Ancheng Pharma Limited</LabelerName>
    <SubstanceName>CYCLANDELATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42227-083-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (42227-083-01)  *  5 mL in 1 VIAL, SINGLE-USE (42227-081-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50) </PackageDescription>
    <NDC11Code>42227-0083-01</NDC11Code>
    <ProductNDC>42227-083</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Cinryze</ProprietaryName>
    <NonProprietaryName>Human C1-esterase Inhibitor</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210115</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125267</ApplicationNumber>
    <LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE).</IndicationAndUsage>
    <Description>CINRYZE (C1 esterase inhibitor [human]) (Freeze-Dried Powder for Reconstitution) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. CINRYZE potency is expressed by its C1 esterase inhibitor activity measured with a validated chromogenic assay. The potency of C1 esterase inhibitor is expressed in International Units (IU), which is related to the current WHO standard for C1 esterase inhibitor products. One International Unit (IU) corresponds to the amount of C1 esterase inhibitor present in 1 mL of normal plasma. The specific activity of CINRYZE is 4.0 to 9.0 U/mg protein. The purity is ≥90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 IU of functionally active C1 esterase inhibitor, pH 6.6 to 7.4, and an osmolality between 200 to 400 mosmol/kg. CINRYZE, when reconstituted with 5 mL of Sterile Water for Injection, USP contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine. The following manufacturing steps are designed to reduce the risk of viral transmission: 1 Screening donors at U.S. licensed blood collection centers to rule out infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus, or Hepatitis C Virus., 2 Testing plasma pools by in-process NAT for parvovirus B19 via minipool testing and the limit of B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL., 3 Use of two independent viral reduction steps in the manufacture of CINRYZE: pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers) and nano filtration through two sequential 15 nm filters.</Description>
  </NDC>
  <NDC>
    <NDCCode>42731-083-01</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (42731-083-01) </PackageDescription>
    <NDC11Code>42731-0083-01</NDC11Code>
    <ProductNDC>42731-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triple Flu Defense</ProprietaryName>
    <NonProprietaryName>Aconitum Napellus, Anas Barbariae, Hepatis Et Cordis Extractum, Antimonium Crudum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Influenzinum, Ipecacuanha, Kali Bichromicum, Nux Vomica, Phosphorus, Phytolacca Decandra</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251125</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nenningers Naturals, LLC</LabelerName>
    <SubstanceName>ACONITUM NAPELLUS WHOLE; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLE; INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLE; IPECAC; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT</SubstanceName>
    <StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Reduce duration and severity of flu-like symptoms.*. *This product has not been tested or the uses evaluated by the FDA.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42806-083-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (42806-083-01) </PackageDescription>
    <NDC11Code>42806-0083-01</NDC11Code>
    <ProductNDC>42806-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208972</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2019-04-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
    <Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro [4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets and 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43742-0083-1</NDCCode>
    <PackageDescription>960 mL in 1 BOTTLE (43742-0083-1)</PackageDescription>
    <NDC11Code>43742-0083-01</NDC11Code>
    <ProductNDC>43742-0083</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Coxsackie A2, A7, B1, B3, B4</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20120921</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Deseret Biologicals, Inc.</LabelerName>
    <SubstanceName>HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B3</SubstanceName>
    <StrengthNumber>500; 500; 500; 500; 500</StrengthNumber>
    <StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43846-0083-1</NDCCode>
    <PackageDescription>57 g in 1 TUBE (43846-0083-1) </PackageDescription>
    <NDC11Code>43846-0083-01</NDC11Code>
    <ProductNDC>43846-0083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Muscle Rescue</ProprietaryName>
    <NonProprietaryName>Arnica Montana, Rhus Tox, Phytolacca Decandra, Pulsatilla (vulgaris), Ruta Graveolens</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240611</StartMarketingDate>
    <EndMarketingDate>20300605</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Peaceful Mountain, Inc.</LabelerName>
    <SubstanceName>ARNICA MONTANA WHOLE; TOXICODENDRON PUBESCENS LEAF; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS WHOLE; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
    <StrengthNumber>3; 4; 12; 12; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240611</StartMarketingDatePackage>
    <EndMarketingDatePackage>20300605</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>May temporarily relieve minor symptoms of muscle aches, pains from overexertion, and injury.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43857-0083-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (43857-0083-1) </PackageDescription>
    <NDC11Code>43857-0083-01</NDC11Code>
    <ProductNDC>43857-0083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bronchiforce</ProprietaryName>
    <NonProprietaryName>Althaea Officinalis, Lobelia Inflata, Rheum (officinale), Verbascum Thapsus, Belladonna, Cuprum Aceticum, Drosera (rotundifolia), Ipecacuanha, Spongia Tosta, Sticta Pulmonaria</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130213</StartMarketingDate>
    <EndMarketingDate>20241112</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>BioActive Nutritional, Inc.</LabelerName>
    <SubstanceName>ALTHAEA OFFICINALIS ROOT; ATROPA BELLADONNA WHOLE; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; LOBELIA INFLATA; RHEUM OFFICINALE ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS</SubstanceName>
    <StrengthNumber>3; 12; 12; 12; 12; 12; 3; 3; 12; 3</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140209</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241112</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of tickling, short dry cough that is worse at night, barking cough with expectoration, cough very deep, and hoarseness after midnight.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>44717-083-01</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (44717-083-01) </PackageDescription>
    <NDC11Code>44717-0083-01</NDC11Code>
    <ProductNDC>44717-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Illuminizing Blendrops Broad Spectrum Spf 40</ProprietaryName>
    <NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240202</StartMarketingDate>
    <EndMarketingDate>20270228</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Wasatch Product Development, LLC</LabelerName>
    <SubstanceName>OCTISALATE; HOMOSALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>5; 6; 12</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240202</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>44911-0083-1</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, DROPPER (44911-0083-1)</PackageDescription>
    <NDC11Code>44911-0083-01</NDC11Code>
    <ProductNDC>44911-0083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infectistat</ProprietaryName>
    <NonProprietaryName>Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra, Symphytum Officinale, Lung (suis), Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia, Causticum, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Natrum Sulphuricum, Phosphorus, Pulsatilla, Rhus Toxicodendron, Silicea, Sulphur, Pyrogenium</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130501</StartMarketingDate>
    <EndMarketingDate>20201103</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Energique, Inc.</LabelerName>
    <SubstanceName>BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; SUS SCROFA LUNG; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF</SubstanceName>
    <StrengthNumber>3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0280-0083-01</NDCCode><ProprietaryName>Alka-seltzer Heartburn Relief Lemon Lime</ProprietaryName><NonProprietaryName>Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)</NonProprietaryName></NDC><NDC><NDCCode>0280-0083-02</NDCCode><ProprietaryName>Alka-seltzer Heartburn Relief Lemon Lime</ProprietaryName><NonProprietaryName>Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)</NonProprietaryName></NDC><NDC><NDCCode>0280-0083-03</NDCCode><ProprietaryName>Alka-seltzer Heartburn Relief Lemon Lime</ProprietaryName><NonProprietaryName>Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)</NonProprietaryName></NDC><NDC><NDCCode>0360-0083-01</NDCCode><ProprietaryName>Calcarea Fluorica</ProprietaryName><NonProprietaryName>Calc Fluor</NonProprietaryName></NDC><NDC><NDCCode>0378-0083-01</NDCCode><ProprietaryName>Captopril And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Captopril And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>11014-0083-1</NDCCode><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11489-083-01</NDCCode><ProprietaryName>Botanics Protecting Day Age Defense Sunscreen Broad Spectrum Spf 15</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>12090-0083-1</NDCCode><ProprietaryName>Lantiseptic Protective</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>12634-083-01</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>12828-0083-1</NDCCode><NonProprietaryName>Epinephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>13107-083-01</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>13668-083-01</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>15631-0083-1</NDCCode><ProprietaryName>Blatta Orientalis</ProprietaryName><NonProprietaryName>Blatta Orientalis</NonProprietaryName></NDC><NDC><NDCCode>16714-083-01</NDCCode><ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName><NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>17337-0083-1</NDCCode><NonProprietaryName>Isotretinoin Micronized</NonProprietaryName></NDC><NDC><NDCCode>17856-0083-1</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>21565-0083-1</NDCCode><NonProprietaryName>Mebrofenin</NonProprietaryName></NDC><NDC><NDCCode>27808-083-01</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>37662-0083-1</NDCCode><ProprietaryName>Calcarea Fluorica</ProprietaryName><NonProprietaryName>Calcarea Fluorica</NonProprietaryName></NDC><NDC><NDCCode>41190-083-01</NDCCode><ProprietaryName>Shoprite</ProprietaryName><NonProprietaryName>Terbinafine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>41366-083-01</NDCCode><ProprietaryName>Cherry Blossom Pear Hand Sanitizer</ProprietaryName><NonProprietaryName>Cherry Blossom Pear Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>42224-0083-1</NDCCode><NonProprietaryName>Cyclandelate</NonProprietaryName></NDC><NDC><NDCCode>42227-083-01</NDCCode><ProprietaryName>Cinryze</ProprietaryName><NonProprietaryName>Human C1-esterase Inhibitor</NonProprietaryName></NDC><NDC><NDCCode>42731-083-01</NDCCode><ProprietaryName>Triple Flu Defense</ProprietaryName><NonProprietaryName>Aconitum Napellus, Anas Barbariae, Hepatis Et Cordis Extractum, Antimonium Crudum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Influenzinum, Ipecacuanha, Kali Bichromicum, Nux Vomica, Phosphorus, Phytolacca Decandra</NonProprietaryName></NDC><NDC><NDCCode>42806-083-01</NDCCode><ProprietaryName>Buspirone Hydrochloride</ProprietaryName><NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43742-0083-1</NDCCode><NonProprietaryName>Coxsackie A2, A7, B1, B3, B4</NonProprietaryName></NDC><NDC><NDCCode>43846-0083-1</NDCCode><ProprietaryName>Muscle Rescue</ProprietaryName><NonProprietaryName>Arnica Montana, Rhus Tox, Phytolacca Decandra, Pulsatilla (vulgaris), Ruta Graveolens</NonProprietaryName></NDC><NDC><NDCCode>43857-0083-1</NDCCode><ProprietaryName>Bronchiforce</ProprietaryName><NonProprietaryName>Althaea Officinalis, Lobelia Inflata, Rheum (officinale), Verbascum Thapsus, Belladonna, Cuprum Aceticum, Drosera (rotundifolia), Ipecacuanha, Spongia Tosta, Sticta Pulmonaria</NonProprietaryName></NDC><NDC><NDCCode>44717-083-01</NDCCode><ProprietaryName>Illuminizing Blendrops Broad Spectrum Spf 40</ProprietaryName><NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>44911-0083-1</NDCCode><ProprietaryName>Infectistat</ProprietaryName><NonProprietaryName>Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra, Symphytum Officinale, Lung (suis), Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia, Causticum, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Natrum Sulphuricum, Phosphorus, Pulsatilla, Rhus Toxicodendron, Silicea, Sulphur, Pyrogenium</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",
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      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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