RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "54575-181-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-181-10)",
      "NDC11Code": "54575-0181-10",
      "ProductNDC": "54575-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Tenuis Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-181-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-181-02)",
      "NDC11Code": "54575-0181-02",
      "ProductNDC": "54575-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Tenuis Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-181-30",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (54575-181-30)",
      "NDC11Code": "54575-0181-30",
      "ProductNDC": "54575-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Tenuis Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-181-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (54575-181-50)",
      "NDC11Code": "54575-0181-50",
      "ProductNDC": "54575-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Tenuis Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "43598-181-11",
      "PackageDescription": "10 mL in 1 VIAL, SINGLE-DOSE (43598-181-11) ",
      "NDC11Code": "43598-0181-11",
      "ProductNDC": "43598-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rezipres",
      "NonProprietaryName": "Ephedrine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231221",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA213536",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "EPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "47",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20231221",
      "SamplePackage": "N",
      "IndicationAndUsage": "REZIPRES® is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.",
      "Description": "REZIPRES® is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. The chemical name of ephedrine hydrochloride is (1R,2S)-(-)-2-methylamino-1-phenyl-1-propanol hydrochloride, and the molecular weight is 201.7 g/mol. Its structural formula is depicted below. Ephedrine hydrochloride is freely soluble in water, soluble in ethanol and stable in aqueous solution. REZIPRES® 47 mg/mL. REZIPRES® 47 mg/mL is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. Each mL contains ephedrine hydrochloride 47 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5. REZIPRES® 47 mg/5 mL (9.4 mg/mL). REZIPRES® 9.4 mg/mL is a clear, colorless, sterile solution for intravenous injection. It can either be used as provided or diluted at 4.7 mg/mL, before intravenous administration. Each mL contains ephedrine hydrochloride 9.4 mg (equivalent to 7.7 mg ephedrine base) and sodium chloride 6.0 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5. REZIPRES® 23.5 mg/5 mL (4.7 mg/mL). REZIPRES® 4.7 mg/mL is a clear, colorless, sterile solution for intravenous injection. It must not be diluted prior to use. Each mL contains ephedrine hydrochloride 4.7 mg (equivalent to 3.8 mg ephedrine base) and sodium chloride 7.5 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5. REZIPRES® 47 mg/10 mL (4.7 mg/mL). REZIPRES® 4.7 mg/mL is a clear, colorless, sterile solution for intravenous injection. It must not be diluted prior to use. Each mL contains ephedrine hydrochloride 4.7 mg (equivalent to 3.8 mg ephedrine base) and sodium chloride 7.5 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5."
    },
    {
      "NDCCode": "49281-181-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-181-25)  > .25 mL in 1 SYRINGE, GLASS (49281-181-00) ",
      "NDC11Code": "49281-0181-25",
      "ProductNDC": "49281-181",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190930",
      "EndMarketingDate": "20201231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190930",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51316-181-10",
      "PackageDescription": "2 BOTTLE, SPRAY in 1 CARTON (51316-181-10)  / 144 SPRAY, METERED in 1 BOTTLE, SPRAY",
      "NDC11Code": "51316-0181-10",
      "ProductNDC": "51316-181",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Nasal",
      "NonProprietaryName": "Fluticasone Propionate",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20240530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207957",
      "LabelerName": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
      "SubstanceName": "FLUTICASONE PROPIONATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes."
    },
    {
      "NDCCode": "52817-181-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (52817-181-10) ",
      "NDC11Code": "52817-0181-10",
      "ProductNDC": "52817-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070923",
      "LabelerName": "TruPharma, LLC",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in four dosage strengths: 0.05 mg, 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake, and the 0.05 mg contains D&C yellow #10 aluminum lake. Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. C 9H 9Cl 2N 3 HCl                  Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
    },
    {
      "NDCCode": "55111-181-79",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (55111-181-79)  > 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "55111-0181-79",
      "ProductNDC": "55111-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076920",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2018-12-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090115",
      "SamplePackage": "N",
      "Description": "Levetiracetam USP is an antiepileptic drug available as beige colored tablets in 250 mg, 500 mg and 750 mg strengths for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder. It is very soluble in water, freely soluble in methanol, chloroform and ethanol. Soluble in acetonitrile and practically insoluble in n-hexane. Levetiracetam tablets USP contain the labeled amount of levetiracetam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, povidone, talc, sodium starch glycolate and coloring agent contains hypromellose 3cp, hypromellose 6cp, iron oxide yellow, iron oxide red, polyethylene glycol 400, polysorbate 80 and titanium dioxide."
    },
    {
      "NDCCode": "55150-181-09",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09)  > 9 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "55150-0181-09",
      "ProductNDC": "55150-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amiodarone Hydrochloride",
      "NonProprietaryName": "Amiodarone Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20171025",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204550",
      "LabelerName": "AuroMedics Pharma LLC",
      "SubstanceName": "AMIODARONE HYDROCHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/9mL",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2021-12-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171025",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)]. Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.",
      "Description": "Amiodarone hydrochloride injection, USP contains amiodarone hydrochloride (C25H29I2NO3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone hydrochloride USP is a white or almost white, fine crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone hydrochloride injection, USP is a sterile clear, pale yellow solution visually free from particulates. Each milliliter of the amiodarone formulation contains 50 mg of amiodarone hydrochloride USP, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone hydrochloride injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)]."
    },
    {
      "NDCCode": "55570-181-10",
      "PackageDescription": "25 kg in 1 BOX (55570-181-10) ",
      "NDC11Code": "55570-0181-10",
      "ProductNDC": "55570-181",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Calcium Succinate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20010111",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Jost Chemical Co.",
      "SubstanceName": "CALCIUM SUCCINATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-05-08",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-01"
    },
    {
      "NDCCode": "59735-181-10",
      "PackageDescription": "1 TUBE in 1 CARTON (59735-181-10)  / 30 mL in 1 TUBE (59735-181-09) ",
      "NDC11Code": "59735-0181-10",
      "ProductNDC": "59735-181",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Your Name Mineral Sheertint Broad Spectrum Spf 20-fair Glow",
      "NonProprietaryName": "Your Name Mineral Sheer Tint",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Mana Product, Inc",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "5; 5",
      "StrengthUnit": "g/30mL; g/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20110201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
    },
    {
      "NDCCode": "60927-115-10",
      "PackageDescription": "1 TUBE in 1 CARTON (60927-115-10)  > 181 g in 1 TUBE",
      "NDC11Code": "60927-0115-10",
      "ProductNDC": "60927-115",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Smarth",
      "ProprietaryNameSuffix": "Extra Strength Baking Soda",
      "NonProprietaryName": "Sodium Monofluorophosphate",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20131201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Carib Sales, LLC",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": "7.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "64220-181-02",
      "PackageDescription": "10 kg in 1 CANISTER (64220-181-02) ",
      "NDC11Code": "64220-0181-02",
      "ProductNDC": "64220-181",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nevirapine Hemihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20141111",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
      "SubstanceName": "NEVIRAPINE HEMIHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-02-03",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "11-NOV-14"
    },
    {
      "NDCCode": "64220-181-05",
      "PackageDescription": "10 kg in 1 DRUM (64220-181-05) ",
      "NDC11Code": "64220-0181-05",
      "ProductNDC": "64220-181",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nevirapine Hemihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20141111",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
      "SubstanceName": "NEVIRAPINE HEMIHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-02-03",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "11-NOV-14"
    },
    {
      "NDCCode": "65145-181-10",
      "PackageDescription": "10 POUCH in 1 CASE (65145-181-10)  / 1 BAG in 1 POUCH (65145-181-01)  / 300 mL in 1 BAG",
      "NDC11Code": "65145-0181-10",
      "ProductNDC": "65145-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Linezolid",
      "NonProprietaryName": "Linezolid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20251223",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219558",
      "LabelerName": "Caplin Steriles Limited",
      "SubstanceName": "LINEZOLID",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/300mL",
      "Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251223",
      "SamplePackage": "N",
      "IndicationAndUsage": "Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of linezolid injection formulation given for longer than 28 days have not been evaluated in controlled clinical trials.",
      "Description": "Linezolid Injection, contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below: Linezolid Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid monohydrate 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag)."
    },
    {
      "NDCCode": "67253-181-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (67253-181-10) ",
      "NDC11Code": "67253-0181-10",
      "ProductNDC": "67253-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin",
      "NonProprietaryName": "Ampicillin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19880225",
      "EndMarketingDate": "20200930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062882",
      "LabelerName": "Par Pharmaceutical",
      "SubstanceName": "AMPICILLIN TRIHYDRATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19880225",
      "EndMarketingDatePackage": "20200430",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67457-181-20",
      "PackageDescription": "10 VIAL in 1 CARTON (67457-181-20)  / 20 mL in 1 VIAL (67457-181-00) ",
      "NDC11Code": "67457-0181-20",
      "ProductNDC": "67457-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketamine Hydrochloride",
      "NonProprietaryName": "Ketamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20130604",
      "EndMarketingDate": "20231031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076092",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "KETAMINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130604",
      "EndMarketingDatePackage": "20231031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67777-181-10",
      "PackageDescription": "720 BOX in 1 CASE (67777-181-10)  / 144 TUBE in 1 BOX (67777-181-09)  / 24 g in 1 TUBE (67777-181-08) ",
      "NDC11Code": "67777-0181-10",
      "ProductNDC": "67777-181",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sodium Monofluorophosphate",
      "NonProprietaryName": "White Toothpaste",
      "DosageFormName": "PASTE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20240716",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Dynarex Corporation",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": "760",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2024-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240716",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps protect against cavities."
    },
    {
      "NDCCode": "68135-181-93",
      "PackageDescription": "1 KIT in 1 CARTON (68135-181-93)  *  10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92)  / .6 mL in 1 VIAL, SINGLE-DOSE *  10 INJECTION, SOLUTION in 1 CARTON (68135-158-17) ",
      "NDC11Code": "68135-0181-93",
      "ProductNDC": "68135-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voxzogo 1.2mg",
      "NonProprietaryName": "Vosoritide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20211119",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA214938",
      "LabelerName": "BioMarin Pharmaceutical Inc.",
      "Status": "Active",
      "LastUpdate": "2025-11-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211119",
      "SamplePackage": "N",
      "IndicationAndUsage": "VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
      "Description": "VOXZOGO contains vosoritide, a human C type natriuretic peptide (CNP) analog. Vosoritide is a 39 amino acid peptide. Its amino acid sequence includes the 37 C terminal amino acids of the human CNP53 sequence plus Pro Gly on the N terminus to convey resistance to neutral endopeptidase (NEP) degradation. Vosoritide is manufactured from Escherichia coli using recombinant DNA technology. Vosoritide has a chemical formula of C176H290N56O51S3 with a molecular weight of 4.1 kDa. Vosoritide has the structural formula shown in Figure 1. Figure 1. VOXZOGO (vosoritide) for injection, is a sterile, preservative-free white-to-yellow lyophilized powder, for subcutaneous administration after reconstitution with Sterile Water for Injection, USP. VOXZOGO is provided as a single-dose vial containing 0.4 mg, 0.56 mg, or 1.2 mg of vosoritide per vial. A pre-filled syringe containing Sterile Water for Injection, USP for use as a diluent is also provided. The contents of each single dose vial are summarized by strength in Table 4. The product contains no preservative."
    },
    {
      "NDCCode": "68382-181-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (68382-181-10) ",
      "NDC11Code": "68382-0181-10",
      "ProductNDC": "68382-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Buspirone Hydrochloride",
      "NonProprietaryName": "Buspirone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140503",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078888",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "BUSPIRONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140503",
      "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 have 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.      Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 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.      Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4.      Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
      "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, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its   molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either 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)."
    },
    {
      "NDCCode": "68647-181-10",
      "PackageDescription": "50000 mL in 1 BOTTLE, GLASS (68647-181-10)",
      "NDC11Code": "68647-0181-10",
      "ProductNDC": "68647-181",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sweat-less",
      "NonProprietaryName": "Nat Mur , Lupulus, Castoreum , Argentum Nit , Syphilinum",
      "DosageFormName": "TINCTURE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Feelgood Health",
      "SubstanceName": "SODIUM CHLORIDE; HOPS; BOWFIN; SILVER NITRATE; CALIFORNIA SHEEPHEAD",
      "StrengthNumber": "6; 30; 30; 6; 30",
      "StrengthUnit": "[hp_X]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Indications: Homeopathic remedy for the relief of excessive sweating."
    },
    {
      "NDCCode": "69079-181-10",
      "PackageDescription": "10 kg in 1 BAG (69079-181-10) ",
      "NDC11Code": "69079-0181-10",
      "ProductNDC": "69079-181",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150421",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Titan Kogyo, Ltd.",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-22",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "21-APR-15"
    },
    {
      "NDCCode": "69584-181-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (69584-181-10) ",
      "NDC11Code": "69584-0181-10",
      "ProductNDC": "69584-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dipyridamole",
      "NonProprietaryName": "Dipyridamole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210415",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040542",
      "LabelerName": "Oxford Pharmaceuticals, LLC",
      "SubstanceName": "DIPYRIDAMOLE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210415",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.",
      "Description": "Dipyridamole USP is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8­ Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:. Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole tablets for oral administration contain:. Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg: Carnauba wax, D&C yellow no. 10, FD&C yellow no. 6, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, propylene glycol, propylparaben, silicon dioxide, sodium citrate, sodium starch glycolate, stearic acid, talc, titanium dioxide, and xanthan gum."
    },
    {
      "NDCCode": "70511-181-84",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70511-181-84)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70511-181-10) ",
      "NDC11Code": "70511-0181-84",
      "ProductNDC": "70511-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Daptomycin",
      "NonProprietaryName": "Daptomycin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA217630",
      "LabelerName": "MAIA Pharmaceuticals, Inc.",
      "SubstanceName": "DAPTOMYCIN",
      "StrengthNumber": "350",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20250401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of:  Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,  Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2)  Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3). Limitations of Use:  Daptomycin for Injection is not indicated for the treatment of pneumonia. (1.4)  Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. (1.4)  Daptomycin for Injection is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs. (1.4). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.5).",
      "Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L- aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L- alanine ε1-lactone. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. The chemical structure is. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown lyophilized powder containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with Sterile Water for Injection [see Dosage and Administration (2.7)]. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. : 1 Daptomycin for Injection 350 mg per vial, contains 350 mg daptomycin and 210 mg arginine hydrochloride. Hydrochloric acid and/or sodium hydroxide is used to adjust the pH. , 2 Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, and 300 mg arginine hydrochloride. Hydrochloric acid and/or sodium hydroxide is used to adjust the pH."
    },
    {
      "NDCCode": "72578-181-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (72578-181-10) ",
      "NDC11Code": "72578-0181-10",
      "ProductNDC": "72578-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin",
      "NonProprietaryName": "Doxepin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202761",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14).",
      "Description": "Doxepin is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, USP equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white or almost white crystalline powder, that is readily soluble in water, in alcohol and in methylene chloride. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet contains the following inactive ingredients: FD&C Blue No.1 aluminium lake, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. In addition 6 mg tablet also contains D&C Yellow No. 10 aluminium lake."
    },
    {
      "NDCCode": "72578-181-77",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (72578-181-77)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "72578-0181-77",
      "ProductNDC": "72578-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin",
      "NonProprietaryName": "Doxepin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202761",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14).",
      "Description": "Doxepin is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, USP equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white or almost white crystalline powder, that is readily soluble in water, in alcohol and in methylene chloride. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet contains the following inactive ingredients: FD&C Blue No.1 aluminium lake, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. In addition 6 mg tablet also contains D&C Yellow No. 10 aluminium lake."
    },
    {
      "NDCCode": "75109-005-10",
      "PackageDescription": "40 POUCH in 1 CANISTER (75109-005-10)  > 181.44 mL in 1 POUCH",
      "NDC11Code": "75109-0005-10",
      "ProductNDC": "75109-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wet Wipe",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200321",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Kangna (Zhejiang) Medical Supplies Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200321",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Apply topically to the skin to help prevent cross contamination. Recommended for repeated use. Dries in seconds."
    },
    {
      "NDCCode": "75109-503-10",
      "PackageDescription": "40 POUCH in 1 CANISTER (75109-503-10)  > 181.44 mL in 1 POUCH",
      "NDC11Code": "75109-0503-10",
      "ProductNDC": "75109-503",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Wipes",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200620",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Kangna (Zhejiang) Medical Supplies Co., Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200621",
      "SamplePackage": "N",
      "IndicationAndUsage": "●For hand sanitizing to decrease bacteria on the skin. ●Apply topically to the skin to help prevent cross contamination. ●Not recommended for repeated use. ●Dries in seconds."
    },
    {
      "NDCCode": "77042-181-10",
      "PackageDescription": "18927.06 L in 1 CONTAINER (77042-181-10)",
      "NDC11Code": "77042-0181-10",
      "ProductNDC": "77042-181",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20200515",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Guide Energy Solutions LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20211231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54575-181-10","ProprietaryName":"Alternaria Tenuis Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"54575-181-02","ProprietaryName":"Alternaria Tenuis Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"54575-181-30","ProprietaryName":"Alternaria Tenuis Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"54575-181-50","ProprietaryName":"Alternaria Tenuis Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"43598-181-11","ProprietaryName":"Rezipres","NonProprietaryName":"Ephedrine Hydrochloride"},{"NDCCode":"49281-181-25","ProprietaryName":"Fluzone Quadrivalent Southern Hemisphere","NonProprietaryName":"Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)"},{"NDCCode":"51316-181-10","ProprietaryName":"Allergy Nasal","NonProprietaryName":"Fluticasone Propionate"},{"NDCCode":"52817-181-10","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"55111-181-79","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"55150-181-09","ProprietaryName":"Amiodarone Hydrochloride","NonProprietaryName":"Amiodarone Hydrochloride"},{"NDCCode":"55570-181-10","NonProprietaryName":"Calcium Succinate"},{"NDCCode":"59735-181-10","ProprietaryName":"Your Name Mineral Sheertint Broad Spectrum Spf 20-fair Glow","NonProprietaryName":"Your Name Mineral Sheer Tint"},{"NDCCode":"60927-115-10","ProprietaryName":"Smarth","NonProprietaryName":"Sodium Monofluorophosphate"},{"NDCCode":"64220-181-02","NonProprietaryName":"Nevirapine Hemihydrate"},{"NDCCode":"64220-181-05","NonProprietaryName":"Nevirapine Hemihydrate"},{"NDCCode":"65145-181-10","ProprietaryName":"Linezolid","NonProprietaryName":"Linezolid"},{"NDCCode":"67253-181-10","ProprietaryName":"Ampicillin","NonProprietaryName":"Ampicillin"},{"NDCCode":"67457-181-20","ProprietaryName":"Ketamine Hydrochloride","NonProprietaryName":"Ketamine Hydrochloride"},{"NDCCode":"67777-181-10","ProprietaryName":"Sodium Monofluorophosphate","NonProprietaryName":"White Toothpaste"},{"NDCCode":"68135-181-93","ProprietaryName":"Voxzogo 1.2mg","NonProprietaryName":"Vosoritide"},{"NDCCode":"68382-181-10","ProprietaryName":"Buspirone Hydrochloride","NonProprietaryName":"Buspirone Hydrochloride"},{"NDCCode":"68647-181-10","ProprietaryName":"Sweat-less","NonProprietaryName":"Nat Mur , Lupulus, Castoreum , Argentum Nit , Syphilinum"},{"NDCCode":"69079-181-10","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"69584-181-10","ProprietaryName":"Dipyridamole","NonProprietaryName":"Dipyridamole"},{"NDCCode":"70511-181-84","ProprietaryName":"Daptomycin","NonProprietaryName":"Daptomycin"},{"NDCCode":"72578-181-10","ProprietaryName":"Doxepin","NonProprietaryName":"Doxepin"},{"NDCCode":"72578-181-77","ProprietaryName":"Doxepin","NonProprietaryName":"Doxepin"},{"NDCCode":"75109-005-10","ProprietaryName":"Wet Wipe","NonProprietaryName":"Alcohol"},{"NDCCode":"75109-503-10","ProprietaryName":"Alcohol Wipes","NonProprietaryName":"Alcohol"},{"NDCCode":"77042-181-10","NonProprietaryName":"Alcohol"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>54575-181-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-181-10)</PackageDescription>
    <NDC11Code>54575-0181-10</NDC11Code>
    <ProductNDC>54575-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alternaria Tenuis Alternata</ProprietaryName>
    <NonProprietaryName>Alternaria Alternata</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-181-02</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-181-02)</PackageDescription>
    <NDC11Code>54575-0181-02</NDC11Code>
    <ProductNDC>54575-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alternaria Tenuis Alternata</ProprietaryName>
    <NonProprietaryName>Alternaria Alternata</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-181-30</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (54575-181-30)</PackageDescription>
    <NDC11Code>54575-0181-30</NDC11Code>
    <ProductNDC>54575-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alternaria Tenuis Alternata</ProprietaryName>
    <NonProprietaryName>Alternaria Alternata</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-181-50</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (54575-181-50)</PackageDescription>
    <NDC11Code>54575-0181-50</NDC11Code>
    <ProductNDC>54575-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alternaria Tenuis Alternata</ProprietaryName>
    <NonProprietaryName>Alternaria Alternata</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-181-11</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, SINGLE-DOSE (43598-181-11) </PackageDescription>
    <NDC11Code>43598-0181-11</NDC11Code>
    <ProductNDC>43598-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rezipres</ProprietaryName>
    <NonProprietaryName>Ephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231221</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA213536</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
    <SubstanceName>EPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>47</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REZIPRES® is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
    <Description>REZIPRES® is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. The chemical name of ephedrine hydrochloride is (1R,2S)-(-)-2-methylamino-1-phenyl-1-propanol hydrochloride, and the molecular weight is 201.7 g/mol. Its structural formula is depicted below. Ephedrine hydrochloride is freely soluble in water, soluble in ethanol and stable in aqueous solution. REZIPRES® 47 mg/mL. REZIPRES® 47 mg/mL is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. Each mL contains ephedrine hydrochloride 47 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5. REZIPRES® 47 mg/5 mL (9.4 mg/mL). REZIPRES® 9.4 mg/mL is a clear, colorless, sterile solution for intravenous injection. It can either be used as provided or diluted at 4.7 mg/mL, before intravenous administration. Each mL contains ephedrine hydrochloride 9.4 mg (equivalent to 7.7 mg ephedrine base) and sodium chloride 6.0 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5. REZIPRES® 23.5 mg/5 mL (4.7 mg/mL). REZIPRES® 4.7 mg/mL is a clear, colorless, sterile solution for intravenous injection. It must not be diluted prior to use. Each mL contains ephedrine hydrochloride 4.7 mg (equivalent to 3.8 mg ephedrine base) and sodium chloride 7.5 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5. REZIPRES® 47 mg/10 mL (4.7 mg/mL). REZIPRES® 4.7 mg/mL is a clear, colorless, sterile solution for intravenous injection. It must not be diluted prior to use. Each mL contains ephedrine hydrochloride 4.7 mg (equivalent to 3.8 mg ephedrine base) and sodium chloride 7.5 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-181-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-181-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-181-00) </PackageDescription>
    <NDC11Code>49281-0181-25</NDC11Code>
    <ProductNDC>49281-181</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20190930</StartMarketingDate>
    <EndMarketingDate>20201231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
    <StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51316-181-10</NDCCode>
    <PackageDescription>2 BOTTLE, SPRAY in 1 CARTON (51316-181-10)  / 144 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>51316-0181-10</NDC11Code>
    <ProductNDC>51316-181</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Nasal</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20240530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207957</ApplicationNumber>
    <LabelerName>CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 sneezing, 4 itchy nose, 5 itchy, watery eyes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52817-181-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (52817-181-10) </PackageDescription>
    <NDC11Code>52817-0181-10</NDC11Code>
    <ProductNDC>52817-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070923</ApplicationNumber>
    <LabelerName>TruPharma, LLC</LabelerName>
    <SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
    <Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in four dosage strengths: 0.05 mg, 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&amp;C yellow #10 aluminum lake, the 0.3 mg contains D&amp;C yellow #10 aluminum lake and FD&amp;C blue #1 aluminum lake, and the 0.05 mg contains D&amp;C yellow #10 aluminum lake. Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. C 9H 9Cl 2N 3 HCl                  Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-181-79</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (55111-181-79)  &gt; 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55111-0181-79</NDC11Code>
    <ProductNDC>55111-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076920</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Levetiracetam USP is an antiepileptic drug available as beige colored tablets in 250 mg, 500 mg and 750 mg strengths for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder. It is very soluble in water, freely soluble in methanol, chloroform and ethanol. Soluble in acetonitrile and practically insoluble in n-hexane. Levetiracetam tablets USP contain the labeled amount of levetiracetam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, povidone, talc, sodium starch glycolate and coloring agent contains hypromellose 3cp, hypromellose 6cp, iron oxide yellow, iron oxide red, polyethylene glycol 400, polysorbate 80 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-181-09</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09)  &gt; 9 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55150-0181-09</NDC11Code>
    <ProductNDC>55150-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20171025</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204550</ApplicationNumber>
    <LabelerName>AuroMedics Pharma LLC</LabelerName>
    <SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/9mL</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)]. Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.</IndicationAndUsage>
    <Description>Amiodarone hydrochloride injection, USP contains amiodarone hydrochloride (C25H29I2NO3HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone hydrochloride has the following structural formula. Amiodarone hydrochloride USP is a white or almost white, fine crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone hydrochloride injection, USP is a sterile clear, pale yellow solution visually free from particulates. Each milliliter of the amiodarone formulation contains 50 mg of amiodarone hydrochloride USP, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone hydrochloride injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>55570-181-10</NDCCode>
    <PackageDescription>25 kg in 1 BOX (55570-181-10) </PackageDescription>
    <NDC11Code>55570-0181-10</NDC11Code>
    <ProductNDC>55570-181</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Calcium Succinate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20010111</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Jost Chemical Co.</LabelerName>
    <SubstanceName>CALCIUM SUCCINATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-05-08</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-01</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>59735-181-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (59735-181-10)  / 30 mL in 1 TUBE (59735-181-09) </PackageDescription>
    <NDC11Code>59735-0181-10</NDC11Code>
    <ProductNDC>59735-181</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Your Name Mineral Sheertint Broad Spectrum Spf 20-fair Glow</ProprietaryName>
    <NonProprietaryName>Your Name Mineral Sheer Tint</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Mana Product, Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>g/30mL; g/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60927-115-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (60927-115-10)  &gt; 181 g in 1 TUBE</PackageDescription>
    <NDC11Code>60927-0115-10</NDC11Code>
    <ProductNDC>60927-115</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Smarth</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength Baking Soda</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20131201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Carib Sales, LLC</LabelerName>
    <SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
    <StrengthNumber>7.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64220-181-02</NDCCode>
    <PackageDescription>10 kg in 1 CANISTER (64220-181-02) </PackageDescription>
    <NDC11Code>64220-0181-02</NDC11Code>
    <ProductNDC>64220-181</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nevirapine Hemihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20141111</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>NEVIRAPINE HEMIHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-02-03</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-NOV-14</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>64220-181-05</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (64220-181-05) </PackageDescription>
    <NDC11Code>64220-0181-05</NDC11Code>
    <ProductNDC>64220-181</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nevirapine Hemihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20141111</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>NEVIRAPINE HEMIHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-02-03</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-NOV-14</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65145-181-10</NDCCode>
    <PackageDescription>10 POUCH in 1 CASE (65145-181-10)  / 1 BAG in 1 POUCH (65145-181-01)  / 300 mL in 1 BAG</PackageDescription>
    <NDC11Code>65145-0181-10</NDC11Code>
    <ProductNDC>65145-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Linezolid</ProprietaryName>
    <NonProprietaryName>Linezolid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219558</ApplicationNumber>
    <LabelerName>Caplin Steriles Limited</LabelerName>
    <SubstanceName>LINEZOLID</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/300mL</StrengthUnit>
    <Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6): 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of linezolid injection formulation given for longer than 28 days have not been evaluated in controlled clinical trials.</IndicationAndUsage>
    <Description>Linezolid Injection, contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below: Linezolid Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid monohydrate 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag).</Description>
  </NDC>
  <NDC>
    <NDCCode>67253-181-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (67253-181-10) </PackageDescription>
    <NDC11Code>67253-0181-10</NDC11Code>
    <ProductNDC>67253-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin</ProprietaryName>
    <NonProprietaryName>Ampicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19880225</StartMarketingDate>
    <EndMarketingDate>20200930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062882</ApplicationNumber>
    <LabelerName>Par Pharmaceutical</LabelerName>
    <SubstanceName>AMPICILLIN TRIHYDRATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19880225</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-181-20</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (67457-181-20)  / 20 mL in 1 VIAL (67457-181-00) </PackageDescription>
    <NDC11Code>67457-0181-20</NDC11Code>
    <ProductNDC>67457-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130604</StartMarketingDate>
    <EndMarketingDate>20231031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076092</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130604</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67777-181-10</NDCCode>
    <PackageDescription>720 BOX in 1 CASE (67777-181-10)  / 144 TUBE in 1 BOX (67777-181-09)  / 24 g in 1 TUBE (67777-181-08) </PackageDescription>
    <NDC11Code>67777-0181-10</NDC11Code>
    <ProductNDC>67777-181</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sodium Monofluorophosphate</ProprietaryName>
    <NonProprietaryName>White Toothpaste</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20240716</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Dynarex Corporation</LabelerName>
    <SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
    <StrengthNumber>760</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240716</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68135-181-93</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (68135-181-93)  *  10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92)  / .6 mL in 1 VIAL, SINGLE-DOSE *  10 INJECTION, SOLUTION in 1 CARTON (68135-158-17) </PackageDescription>
    <NDC11Code>68135-0181-93</NDC11Code>
    <ProductNDC>68135-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voxzogo 1.2mg</ProprietaryName>
    <NonProprietaryName>Vosoritide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20211119</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214938</ApplicationNumber>
    <LabelerName>BioMarin Pharmaceutical Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
    <Description>VOXZOGO contains vosoritide, a human C type natriuretic peptide (CNP) analog. Vosoritide is a 39 amino acid peptide. Its amino acid sequence includes the 37 C terminal amino acids of the human CNP53 sequence plus Pro Gly on the N terminus to convey resistance to neutral endopeptidase (NEP) degradation. Vosoritide is manufactured from Escherichia coli using recombinant DNA technology. Vosoritide has a chemical formula of C176H290N56O51S3 with a molecular weight of 4.1 kDa. Vosoritide has the structural formula shown in Figure 1. Figure 1. VOXZOGO (vosoritide) for injection, is a sterile, preservative-free white-to-yellow lyophilized powder, for subcutaneous administration after reconstitution with Sterile Water for Injection, USP. VOXZOGO is provided as a single-dose vial containing 0.4 mg, 0.56 mg, or 1.2 mg of vosoritide per vial. A pre-filled syringe containing Sterile Water for Injection, USP for use as a diluent is also provided. The contents of each single dose vial are summarized by strength in Table 4. The product contains no preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-181-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (68382-181-10) </PackageDescription>
    <NDC11Code>68382-0181-10</NDC11Code>
    <ProductNDC>68382-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140503</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078888</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140503</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 have 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.      Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 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.      Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4.      Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.</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, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its   molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either 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).</Description>
  </NDC>
  <NDC>
    <NDCCode>68647-181-10</NDCCode>
    <PackageDescription>50000 mL in 1 BOTTLE, GLASS (68647-181-10)</PackageDescription>
    <NDC11Code>68647-0181-10</NDC11Code>
    <ProductNDC>68647-181</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sweat-less</ProprietaryName>
    <NonProprietaryName>Nat Mur , Lupulus, Castoreum , Argentum Nit , Syphilinum</NonProprietaryName>
    <DosageFormName>TINCTURE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Feelgood Health</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; HOPS; BOWFIN; SILVER NITRATE; CALIFORNIA SHEEPHEAD</SubstanceName>
    <StrengthNumber>6; 30; 30; 6; 30</StrengthNumber>
    <StrengthUnit>[hp_X]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Indications: Homeopathic remedy for the relief of excessive sweating.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69079-181-10</NDCCode>
    <PackageDescription>10 kg in 1 BAG (69079-181-10) </PackageDescription>
    <NDC11Code>69079-0181-10</NDC11Code>
    <ProductNDC>69079-181</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150421</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Titan Kogyo, Ltd.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-22</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-APR-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>69584-181-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (69584-181-10) </PackageDescription>
    <NDC11Code>69584-0181-10</NDC11Code>
    <ProductNDC>69584-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dipyridamole</ProprietaryName>
    <NonProprietaryName>Dipyridamole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040542</ApplicationNumber>
    <LabelerName>Oxford Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>DIPYRIDAMOLE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.</IndicationAndUsage>
    <Description>Dipyridamole USP is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8­ Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:. Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole tablets for oral administration contain:. Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg: Carnauba wax, D&amp;C yellow no. 10, FD&amp;C yellow no. 6, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, propylene glycol, propylparaben, silicon dioxide, sodium citrate, sodium starch glycolate, stearic acid, talc, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>70511-181-84</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70511-181-84)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70511-181-10) </PackageDescription>
    <NDC11Code>70511-0181-84</NDC11Code>
    <ProductNDC>70511-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin</ProprietaryName>
    <NonProprietaryName>Daptomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA217630</ApplicationNumber>
    <LabelerName>MAIA Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of:  Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,  Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2)  Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3). Limitations of Use:  Daptomycin for Injection is not indicated for the treatment of pneumonia. (1.4)  Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. (1.4)  Daptomycin for Injection is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs. (1.4). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.5).</IndicationAndUsage>
    <Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L- aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L- alanine ε1-lactone. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. The chemical structure is. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown lyophilized powder containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with Sterile Water for Injection [see Dosage and Administration (2.7)]. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. : 1 Daptomycin for Injection 350 mg per vial, contains 350 mg daptomycin and 210 mg arginine hydrochloride. Hydrochloric acid and/or sodium hydroxide is used to adjust the pH. , 2 Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, and 300 mg arginine hydrochloride. Hydrochloric acid and/or sodium hydroxide is used to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>72578-181-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (72578-181-10) </PackageDescription>
    <NDC11Code>72578-0181-10</NDC11Code>
    <ProductNDC>72578-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin</ProprietaryName>
    <NonProprietaryName>Doxepin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202761</ApplicationNumber>
    <LabelerName>Viona Pharmaceuticals Inc</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14).</IndicationAndUsage>
    <Description>Doxepin is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, USP equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white or almost white crystalline powder, that is readily soluble in water, in alcohol and in methylene chloride. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet contains the following inactive ingredients: FD&amp;C Blue No.1 aluminium lake, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. In addition 6 mg tablet also contains D&amp;C Yellow No. 10 aluminium lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>72578-181-77</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (72578-181-77)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>72578-0181-77</NDC11Code>
    <ProductNDC>72578-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin</ProprietaryName>
    <NonProprietaryName>Doxepin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202761</ApplicationNumber>
    <LabelerName>Viona Pharmaceuticals Inc</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14).</IndicationAndUsage>
    <Description>Doxepin is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, USP equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white or almost white crystalline powder, that is readily soluble in water, in alcohol and in methylene chloride. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet contains the following inactive ingredients: FD&amp;C Blue No.1 aluminium lake, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. In addition 6 mg tablet also contains D&amp;C Yellow No. 10 aluminium lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>75109-005-10</NDCCode>
    <PackageDescription>40 POUCH in 1 CANISTER (75109-005-10)  &gt; 181.44 mL in 1 POUCH</PackageDescription>
    <NDC11Code>75109-0005-10</NDC11Code>
    <ProductNDC>75109-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wet Wipe</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200321</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Kangna (Zhejiang) Medical Supplies Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200321</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Apply topically to the skin to help prevent cross contamination. Recommended for repeated use. Dries in seconds.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75109-503-10</NDCCode>
    <PackageDescription>40 POUCH in 1 CANISTER (75109-503-10)  &gt; 181.44 mL in 1 POUCH</PackageDescription>
    <NDC11Code>75109-0503-10</NDC11Code>
    <ProductNDC>75109-503</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Wipes</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200620</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Kangna (Zhejiang) Medical Supplies Co., Ltd.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>●For hand sanitizing to decrease bacteria on the skin. ●Apply topically to the skin to help prevent cross contamination. ●Not recommended for repeated use. ●Dries in seconds.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>77042-181-10</NDCCode>
    <PackageDescription>18927.06 L in 1 CONTAINER (77042-181-10)</PackageDescription>
    <NDC11Code>77042-0181-10</NDC11Code>
    <ProductNDC>77042-181</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>20200515</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Guide Energy Solutions LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>
                    

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Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
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      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
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}
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