RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "41250-196-46",
      "PackageDescription": "130 g in 1 CAN (41250-196-46) ",
      "NDC11Code": "41250-0196-46",
      "ProductNDC": "41250-196",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Miconazole Nitrate",
      "NonProprietaryName": "Athletes Foot Powder Spray Talc Free",
      "DosageFormName": "AEROSOL, POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180404",
      "EndMarketingDate": "20260831",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Meijer Distribution Inc",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "2.6",
      "StrengthUnit": "g/130g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180404",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris). relieves symptoms of athlete's foot, including itching, burning and cracking."
    },
    {
      "NDCCode": "55319-196-46",
      "PackageDescription": "130 g in 1 CAN (55319-196-46) ",
      "NDC11Code": "55319-0196-46",
      "ProductNDC": "55319-196",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tolnafate",
      "NonProprietaryName": "Tolnaftate Powder Spray",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Family Dollar Services Inc.",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "g/130g",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20180901",
      "SamplePackage": "N",
      "IndicationAndUsage": "cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking."
    },
    {
      "NDCCode": "41250-563-46",
      "PackageDescription": "130 g in 1 CAN (41250-563-46) ",
      "NDC11Code": "41250-0563-46",
      "ProductNDC": "41250-563",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tolnaftate",
      "NonProprietaryName": "Tolnaftate Jock Itch Powder Spray - Talc Free",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200919",
      "EndMarketingDate": "20260630",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Meijer Distribution Inc",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "g/130g",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200919",
      "EndMarketingDatePackage": "20260630",
      "SamplePackage": "N",
      "IndicationAndUsage": "cures most jock itch (tinea cruris). relieves itching, burning a d chafing associated with jock itch."
    },
    {
      "NDCCode": "41250-954-46",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (41250-954-46)  > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "41250-0954-46",
      "ProductNDC": "41250-954",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief D",
      "NonProprietaryName": "Loratadine, Pseudoephedrine Sulfate",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076050",
      "LabelerName": "Meijer Distribution Inc",
      "SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20180615",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itchy, watery eyes. runny nose. itching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "21695-196-01",
      "PackageDescription": "60 POWDER in 1 INHALER (21695-196-01)",
      "NDC11Code": "21695-0196-01",
      "ProductNDC": "21695-196",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Advair",
      "ProprietaryNameSuffix": "Diskus",
      "NonProprietaryName": "Fluticasone Propionate And Salmeterol",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL; RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20010205",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021077",
      "LabelerName": "Rebel Distributors Corp.",
      "SubstanceName": "SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE",
      "StrengthNumber": "50; 250",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: 1 Treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).",
      "Description": "ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate, and it has the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are specially designed plastic devices containing a double-foil blister strip of a powder formulation of fluticasone propionate and salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 100, 250, or 500 mcg of microfine fluticasone propionate and 72.5 mcg of microfine salmeterol xinafoate salt, equivalent to 50 mcg of salmeterol base, in 12.5 mg of formulation containing lactose (which contains milk proteins). Each blister contains 1 complete dose of both medications. After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, 250/50, and 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range, 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) patients with asthma inhaling maximally through the DISKUS device show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric patients with asthma inhaling maximally through the DISKUS device show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old patient set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old patient set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile."
    },
    {
      "NDCCode": "41250-163-08",
      "PackageDescription": "221 mL in 1 BOTTLE, PUMP (41250-163-08)",
      "NDC11Code": "41250-0163-08",
      "ProductNDC": "41250-163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming",
      "ProprietaryNameSuffix": "Pear",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "MEIJER DISTRIBUTION INC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "HELPS REDUCE BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "41250-177-08",
      "PackageDescription": "221 mL in 1 BOTTLE, PUMP (41250-177-08)",
      "NDC11Code": "41250-0177-08",
      "ProductNDC": "41250-177",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming",
      "ProprietaryNameSuffix": "Original",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "MEIJER DISTRIBUTION INC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "HELPS REDUCES BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "41250-177-32",
      "PackageDescription": "936 mL in 1 BOTTLE, PUMP (41250-177-32)",
      "NDC11Code": "41250-0177-32",
      "ProductNDC": "41250-177",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming",
      "ProprietaryNameSuffix": "Original",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "MEIJER DISTRIBUTION INC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "HELPS REDUCES BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "41250-186-08",
      "PackageDescription": "221 mL in 1 BOTTLE, PUMP (41250-186-08)",
      "NDC11Code": "41250-0186-08",
      "ProductNDC": "41250-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming",
      "ProprietaryNameSuffix": "Cranberry",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "MEIJER DISTRIBUTION INC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "HELPS REDUCE BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "41250-808-96",
      "PackageDescription": "221.8 mL in 1 BOTTLE, PUMP (41250-808-96)",
      "NDC11Code": "41250-0808-96",
      "ProductNDC": "41250-808",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foaming Hand Wash",
      "NonProprietaryName": "Triclosan 0.46%",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Meijer Distribution",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "41250-962-45",
      "PackageDescription": "946 mL in 1 PACKAGE (41250-962-45)",
      "NDC11Code": "41250-0962-45",
      "ProductNDC": "41250-962",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foaming Hand Wash",
      "NonProprietaryName": "Triclosan 0.46%",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Meijer Distribution",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "41250-962-96",
      "PackageDescription": "221 mL in 1 BOTTLE, PUMP (41250-962-96)",
      "NDC11Code": "41250-0962-96",
      "ProductNDC": "41250-962",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foaming Hand Wash",
      "NonProprietaryName": "Triclosan 0.46%",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Meijer Distribution",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": ".46",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "0019-5505-06",
      "PackageDescription": "25 BOTTLE, GLASS in 1 CASE (0019-5505-06)  > 50 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "00019-5505-06",
      "ProductNDC": "0019-5505",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hexabrix",
      "NonProprietaryName": "Ioxaglate Meglumine And Ioxaglate Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "19850726",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018905",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM",
      "StrengthNumber": "393; 196",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "0019-5505-08",
      "PackageDescription": "12 BOTTLE, GLASS in 1 CASE (0019-5505-08)  > 100 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "00019-5505-08",
      "ProductNDC": "0019-5505",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hexabrix",
      "NonProprietaryName": "Ioxaglate Meglumine And Ioxaglate Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "19850726",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018905",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM",
      "StrengthNumber": "393; 196",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "0019-5505-21",
      "PackageDescription": "12 BOTTLE, GLASS in 1 CASE (0019-5505-21)  > 200 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "00019-5505-21",
      "ProductNDC": "0019-5505",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hexabrix",
      "NonProprietaryName": "Ioxaglate Meglumine And Ioxaglate Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "19850726",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018905",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM",
      "StrengthNumber": "393; 196",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "0019-5505-51",
      "PackageDescription": "10 BOTTLE, GLASS in 1 CASE (0019-5505-51)  > 20 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "00019-5505-51",
      "ProductNDC": "0019-5505",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hexabrix",
      "NonProprietaryName": "Ioxaglate Meglumine And Ioxaglate Sodium",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "19850726",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018905",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM",
      "StrengthNumber": "393; 196",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "0404-9986-20",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9986-20)  / 1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00404-9986-20",
      "ProductNDC": "0404-9986",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20221014",
      "EndMarketingDate": "20240430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040730",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20221014",
      "EndMarketingDatePackage": "20240430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.",
      "Description": "Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride USP, 20 mg. Preservatives: Methylparaben NF, 0.65 mg; Propylparaben NF, 0.35 mg. Inactives: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid USP to adjust pH (3.4 to 4.4) and Water for Injection. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64."
    },
    {
      "NDCCode": "0404-9994-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9994-01)  / 1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00404-9994-01",
      "ProductNDC": "0404-9994",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20230717",
      "EndMarketingDate": "20260131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213667",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230717",
      "EndMarketingDatePackage": "20260131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.",
      "Description": "Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride USP, 20 mg. Preservative Free Formulation. Inactives: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid USP to adjust pH (3.4 to 4.4) and Water for Injection. Hydralazine Hydrochloride USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64."
    },
    {
      "NDCCode": "0409-3294-25",
      "PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-25)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-15) ",
      "NDC11Code": "00409-3294-25",
      "ProductNDC": "0409-3294",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Acetate",
      "NonProprietaryName": "Potassium Acetate",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20131223",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018896",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "POTASSIUM ACETATE",
      "StrengthNumber": "196.3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20131223",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.",
      "Description": "Potassium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of potassium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 196 mg of potassium acetate which provides 2 mEq each of potassium (K+) and acetate (CH3COO¯). The solution may contain acetic acid for pH adjustment. The pH is 6.2 (range: 5.5 to 8.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity is 1.089. The Pharmacy Bulk Package is a sterile dosage which contains multiple single doses for use only in a pharmacy bulk admixture program. The solution is intended as an alternative to potassium chloride to provide potassium ion (K+) for addition to large volume infusion fluids for intravenous use. Potassium Acetate, USP is chemically designated CH3COOK, and is comprised of colorless crystals or a white crystalline powder that is very soluble in water. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures. The Pharmacy Bulk Package contains no bacteriostat, antimicrobial agent, or added buffer. Multiple single doses may be dispensed during continual aliquoting operations."
    },
    {
      "NDCCode": "0409-3294-51",
      "PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-51)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-61) ",
      "NDC11Code": "00409-3294-51",
      "ProductNDC": "0409-3294",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Acetate",
      "NonProprietaryName": "Potassium Acetate",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20050705",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018896",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "POTASSIUM ACETATE",
      "StrengthNumber": "196.3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20050705",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.",
      "Description": "Potassium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of potassium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 196 mg of potassium acetate which provides 2 mEq each of potassium (K+) and acetate (CH3COO-). The solution may contain acetic acid for pH adjustment. The pH is 6.2 (range: 5.5 to 8.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity is 1.089. The Pharmacy Bulk Package is a sterile dosage which contains multiple single doses for use only in a pharmacy bulk admixture program. The solution is intended as an alternative to potassium chloride to provide potassium ion (K+) for addition to large volume infusion fluids for intravenous use. Potassium Acetate, USP is chemically designated CH3COOK, and is comprised of colorless crystals or a white crystalline powder that is very soluble in water. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures. The Pharmacy Bulk Package contains no bacteriostat, antimicrobial agent, or added buffer. Multiple single doses may be dispensed during continual aliquoting operations."
    },
    {
      "NDCCode": "0517-0901-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25)  > 1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-0901-25",
      "ProductNDC": "0517-0901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19970630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040136",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-05-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19970630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.",
      "Description": "HydrALAZINE Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Each milliliter of the sterile, nonpyrogenic colorless solution contains Hydralazine Hydrochloride, 20 mg, Methylparaben, 0.65 mg, Propylparaben, 0.35 mg, Propylene Glycol, 103.6 mg, and Water for Injection q.s. The pH of the solution is 3.4 to 4.4. pH may be adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Hydralazine Hydrochloride is 1-Hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula C8H8N4HCl. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64."
    },
    {
      "NDCCode": "0517-2053-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2053-25)  > 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00517-2053-25",
      "ProductNDC": "0517-2053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Acetate",
      "NonProprietaryName": "Potassium Acetate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19900930",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "American Regent, Inc.",
      "SubstanceName": "POTASSIUM ACETATE",
      "StrengthNumber": "196",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-20",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0527-1329-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0527-1329-01) ",
      "NDC11Code": "00527-1329-01",
      "ProductNDC": "0527-1329",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bethanechol Chloride",
      "NonProprietaryName": "Bethanechol Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040677",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "BETHANECHOL CHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20080327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
      "Description": "Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow No. 10 aluminum lake."
    },
    {
      "NDCCode": "0527-1332-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0527-1332-01) ",
      "NDC11Code": "00527-1332-01",
      "ProductNDC": "0527-1332",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bethanechol Chloride",
      "NonProprietaryName": "Bethanechol Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040677",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "BETHANECHOL CHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20080327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
      "Description": "Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow No. 10 aluminum lake."
    },
    {
      "NDCCode": "0527-1340-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0527-1340-01) ",
      "NDC11Code": "00527-1340-01",
      "ProductNDC": "0527-1340",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bethanechol Chloride",
      "NonProprietaryName": "Bethanechol Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040677",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "BETHANECHOL CHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20080327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
      "Description": "Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow No. 10 aluminum lake."
    },
    {
      "NDCCode": "0527-1356-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0527-1356-01) ",
      "NDC11Code": "00527-1356-01",
      "ProductNDC": "0527-1356",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bethanechol Chloride",
      "NonProprietaryName": "Bethanechol Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040677",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "BETHANECHOL CHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20080327",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
      "Description": "Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow No. 10 aluminum lake."
    },
    {
      "NDCCode": "0615-7973-05",
      "PackageDescription": "15 TABLET in 1 BLISTER PACK (0615-7973-05) ",
      "NDC11Code": "00615-7973-05",
      "ProductNDC": "0615-7973",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040901",
      "LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221110",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGE:  Essential hypertension, alone or as an adjunct.",
      "Description": "DESCRIPTION:  HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275ºC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6."
    },
    {
      "NDCCode": "0615-7973-39",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-7973-39) ",
      "NDC11Code": "00615-7973-39",
      "ProductNDC": "0615-7973",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040901",
      "LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100101",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGE:  Essential hypertension, alone or as an adjunct.",
      "Description": "DESCRIPTION:  HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275ºC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6."
    },
    {
      "NDCCode": "0641-6231-25",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25)  / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01) ",
      "NDC11Code": "00641-6231-25",
      "ProductNDC": "0641-6231",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydralazine Hydrochloride",
      "NonProprietaryName": "Hydralazine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20201218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213667",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.",
      "Description": "Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride USP, 20 mg. Preservative Free Formulation. Inactives: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid USP to adjust pH (3.4 to  4.4) and Water for Injection. Hydralazine Hydrochloride USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula: C8H8N4HCl. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64."
    },
    {
      "NDCCode": "0703-3671-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-01)  / 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00703-3671-01",
      "ProductNDC": "0703-3671",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methotrexate",
      "NonProprietaryName": "Methotrexate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
      "StartMarketingDate": "20120731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040843",
      "LabelerName": "Teva Parenteral Medicines, Inc.",
      "SubstanceName": "METHOTREXATE SODIUM",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180608",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).",
      "Description": "Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5            M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"41250-196-46","ProprietaryName":"Miconazole Nitrate","NonProprietaryName":"Athletes Foot Powder Spray Talc Free"},{"NDCCode":"55319-196-46","ProprietaryName":"Tolnafate","NonProprietaryName":"Tolnaftate Powder Spray"},{"NDCCode":"41250-563-46","ProprietaryName":"Tolnaftate","NonProprietaryName":"Tolnaftate Jock Itch Powder Spray - Talc Free"},{"NDCCode":"41250-954-46","ProprietaryName":"Allergy Relief D","NonProprietaryName":"Loratadine, Pseudoephedrine Sulfate"},{"NDCCode":"21695-196-01","ProprietaryName":"Advair","NonProprietaryName":"Fluticasone Propionate And Salmeterol"},{"NDCCode":"41250-163-08","ProprietaryName":"Antibacterial Foaming","NonProprietaryName":"Triclosan"},{"NDCCode":"41250-177-08","ProprietaryName":"Antibacterial Foaming","NonProprietaryName":"Triclosan"},{"NDCCode":"41250-177-32","ProprietaryName":"Antibacterial Foaming","NonProprietaryName":"Triclosan"},{"NDCCode":"41250-186-08","ProprietaryName":"Antibacterial Foaming","NonProprietaryName":"Triclosan"},{"NDCCode":"41250-808-96","ProprietaryName":"Foaming Hand Wash","NonProprietaryName":"Triclosan 0.46%"},{"NDCCode":"41250-962-45","ProprietaryName":"Foaming Hand Wash","NonProprietaryName":"Triclosan 0.46%"},{"NDCCode":"41250-962-96","ProprietaryName":"Foaming Hand Wash","NonProprietaryName":"Triclosan 0.46%"},{"NDCCode":"0019-5505-06","ProprietaryName":"Hexabrix","NonProprietaryName":"Ioxaglate Meglumine And Ioxaglate Sodium"},{"NDCCode":"0019-5505-08","ProprietaryName":"Hexabrix","NonProprietaryName":"Ioxaglate Meglumine And Ioxaglate Sodium"},{"NDCCode":"0019-5505-21","ProprietaryName":"Hexabrix","NonProprietaryName":"Ioxaglate Meglumine And Ioxaglate Sodium"},{"NDCCode":"0019-5505-51","ProprietaryName":"Hexabrix","NonProprietaryName":"Ioxaglate Meglumine And Ioxaglate Sodium"},{"NDCCode":"0404-9986-20","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"0404-9994-01","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"0409-3294-25","ProprietaryName":"Potassium Acetate","NonProprietaryName":"Potassium Acetate"},{"NDCCode":"0409-3294-51","ProprietaryName":"Potassium Acetate","NonProprietaryName":"Potassium Acetate"},{"NDCCode":"0517-0901-25","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"0517-2053-25","ProprietaryName":"Potassium Acetate","NonProprietaryName":"Potassium Acetate"},{"NDCCode":"0527-1329-01","ProprietaryName":"Bethanechol Chloride","NonProprietaryName":"Bethanechol Chloride"},{"NDCCode":"0527-1332-01","ProprietaryName":"Bethanechol Chloride","NonProprietaryName":"Bethanechol Chloride"},{"NDCCode":"0527-1340-01","ProprietaryName":"Bethanechol Chloride","NonProprietaryName":"Bethanechol Chloride"},{"NDCCode":"0527-1356-01","ProprietaryName":"Bethanechol Chloride","NonProprietaryName":"Bethanechol Chloride"},{"NDCCode":"0615-7973-05","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"0615-7973-39","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"0641-6231-25","ProprietaryName":"Hydralazine Hydrochloride","NonProprietaryName":"Hydralazine Hydrochloride"},{"NDCCode":"0703-3671-01","ProprietaryName":"Methotrexate","NonProprietaryName":"Methotrexate"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>41250-196-46</NDCCode>
    <PackageDescription>130 g in 1 CAN (41250-196-46) </PackageDescription>
    <NDC11Code>41250-0196-46</NDC11Code>
    <ProductNDC>41250-196</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Miconazole Nitrate</ProprietaryName>
    <NonProprietaryName>Athletes Foot Powder Spray Talc Free</NonProprietaryName>
    <DosageFormName>AEROSOL, POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180404</StartMarketingDate>
    <EndMarketingDate>20260831</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Meijer Distribution Inc</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>2.6</StrengthNumber>
    <StrengthUnit>g/130g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180404</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris). relieves symptoms of athlete's foot, including itching, burning and cracking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55319-196-46</NDCCode>
    <PackageDescription>130 g in 1 CAN (55319-196-46) </PackageDescription>
    <NDC11Code>55319-0196-46</NDC11Code>
    <ProductNDC>55319-196</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tolnafate</ProprietaryName>
    <NonProprietaryName>Tolnaftate Powder Spray</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Family Dollar Services Inc.</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>g/130g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-563-46</NDCCode>
    <PackageDescription>130 g in 1 CAN (41250-563-46) </PackageDescription>
    <NDC11Code>41250-0563-46</NDC11Code>
    <ProductNDC>41250-563</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tolnaftate</ProprietaryName>
    <NonProprietaryName>Tolnaftate Jock Itch Powder Spray - Talc Free</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200919</StartMarketingDate>
    <EndMarketingDate>20260630</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Meijer Distribution Inc</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>g/130g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200919</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>cures most jock itch (tinea cruris). relieves itching, burning a d chafing associated with jock itch.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-954-46</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (41250-954-46)  &gt; 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>41250-0954-46</NDC11Code>
    <ProductNDC>41250-954</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief D</ProprietaryName>
    <NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076050</ApplicationNumber>
    <LabelerName>Meijer Distribution Inc</LabelerName>
    <SubstanceName>LORATADINE; PSEUDOEPHEDRINE SULFATE</SubstanceName>
    <StrengthNumber>5; 120</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itchy, watery eyes. runny nose. itching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21695-196-01</NDCCode>
    <PackageDescription>60 POWDER in 1 INHALER (21695-196-01)</PackageDescription>
    <NDC11Code>21695-0196-01</NDC11Code>
    <ProductNDC>21695-196</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Advair</ProprietaryName>
    <ProprietaryNameSuffix>Diskus</ProprietaryNameSuffix>
    <NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20010205</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021077</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50; 250</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: 1 Treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
    <Description>ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of ADVAIR DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of ADVAIR DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The chemical name of salmeterol xinafoate is 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate, and it has the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are specially designed plastic devices containing a double-foil blister strip of a powder formulation of fluticasone propionate and salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 100, 250, or 500 mcg of microfine fluticasone propionate and 72.5 mcg of microfine salmeterol xinafoate salt, equivalent to 50 mcg of salmeterol base, in 12.5 mg of formulation containing lactose (which contains milk proteins). Each blister contains 1 complete dose of both medications. After a blister containing medication is opened by activating the device, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ADVAIR DISKUS delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from ADVAIR DISKUS 100/50, 250/50, and 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS® inhalation device was 82.4 L/min (range, 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) patients with asthma inhaling maximally through the DISKUS device show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric patients with asthma inhaling maximally through the DISKUS device show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old patient set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old patient set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>41250-163-08</NDCCode>
    <PackageDescription>221 mL in 1 BOTTLE, PUMP (41250-163-08)</PackageDescription>
    <NDC11Code>41250-0163-08</NDC11Code>
    <ProductNDC>41250-163</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Foaming</ProprietaryName>
    <ProprietaryNameSuffix>Pear</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>MEIJER DISTRIBUTION INC</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>HELPS REDUCE BACTERIA ON THE SKIN.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-177-08</NDCCode>
    <PackageDescription>221 mL in 1 BOTTLE, PUMP (41250-177-08)</PackageDescription>
    <NDC11Code>41250-0177-08</NDC11Code>
    <ProductNDC>41250-177</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Foaming</ProprietaryName>
    <ProprietaryNameSuffix>Original</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>MEIJER DISTRIBUTION INC</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>HELPS REDUCES BACTERIA ON THE SKIN.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-177-32</NDCCode>
    <PackageDescription>936 mL in 1 BOTTLE, PUMP (41250-177-32)</PackageDescription>
    <NDC11Code>41250-0177-32</NDC11Code>
    <ProductNDC>41250-177</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Foaming</ProprietaryName>
    <ProprietaryNameSuffix>Original</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>MEIJER DISTRIBUTION INC</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>HELPS REDUCES BACTERIA ON THE SKIN.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-186-08</NDCCode>
    <PackageDescription>221 mL in 1 BOTTLE, PUMP (41250-186-08)</PackageDescription>
    <NDC11Code>41250-0186-08</NDC11Code>
    <ProductNDC>41250-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Foaming</ProprietaryName>
    <ProprietaryNameSuffix>Cranberry</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>MEIJER DISTRIBUTION INC</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>HELPS REDUCE BACTERIA ON THE SKIN.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-808-96</NDCCode>
    <PackageDescription>221.8 mL in 1 BOTTLE, PUMP (41250-808-96)</PackageDescription>
    <NDC11Code>41250-0808-96</NDC11Code>
    <ProductNDC>41250-808</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Foaming Hand Wash</ProprietaryName>
    <NonProprietaryName>Triclosan 0.46%</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Meijer Distribution</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-962-45</NDCCode>
    <PackageDescription>946 mL in 1 PACKAGE (41250-962-45)</PackageDescription>
    <NDC11Code>41250-0962-45</NDC11Code>
    <ProductNDC>41250-962</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Foaming Hand Wash</ProprietaryName>
    <NonProprietaryName>Triclosan 0.46%</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Meijer Distribution</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41250-962-96</NDCCode>
    <PackageDescription>221 mL in 1 BOTTLE, PUMP (41250-962-96)</PackageDescription>
    <NDC11Code>41250-0962-96</NDC11Code>
    <ProductNDC>41250-962</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Foaming Hand Wash</ProprietaryName>
    <NonProprietaryName>Triclosan 0.46%</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Meijer Distribution</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.46</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0019-5505-06</NDCCode>
    <PackageDescription>25 BOTTLE, GLASS in 1 CASE (0019-5505-06)  &gt; 50 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00019-5505-06</NDC11Code>
    <ProductNDC>0019-5505</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hexabrix</ProprietaryName>
    <NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>19850726</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018905</ApplicationNumber>
    <LabelerName>Mallinckrodt Inc.</LabelerName>
    <SubstanceName>IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM</SubstanceName>
    <StrengthNumber>393; 196</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0019-5505-08</NDCCode>
    <PackageDescription>12 BOTTLE, GLASS in 1 CASE (0019-5505-08)  &gt; 100 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00019-5505-08</NDC11Code>
    <ProductNDC>0019-5505</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hexabrix</ProprietaryName>
    <NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>19850726</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018905</ApplicationNumber>
    <LabelerName>Mallinckrodt Inc.</LabelerName>
    <SubstanceName>IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM</SubstanceName>
    <StrengthNumber>393; 196</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0019-5505-21</NDCCode>
    <PackageDescription>12 BOTTLE, GLASS in 1 CASE (0019-5505-21)  &gt; 200 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00019-5505-21</NDC11Code>
    <ProductNDC>0019-5505</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hexabrix</ProprietaryName>
    <NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>19850726</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018905</ApplicationNumber>
    <LabelerName>Mallinckrodt Inc.</LabelerName>
    <SubstanceName>IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM</SubstanceName>
    <StrengthNumber>393; 196</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0019-5505-51</NDCCode>
    <PackageDescription>10 BOTTLE, GLASS in 1 CASE (0019-5505-51)  &gt; 20 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00019-5505-51</NDC11Code>
    <ProductNDC>0019-5505</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hexabrix</ProprietaryName>
    <NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVASCULAR</RouteName>
    <StartMarketingDate>19850726</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018905</ApplicationNumber>
    <LabelerName>Mallinckrodt Inc.</LabelerName>
    <SubstanceName>IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM</SubstanceName>
    <StrengthNumber>393; 196</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0404-9986-20</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9986-20)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00404-9986-20</NDC11Code>
    <ProductNDC>0404-9986</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221014</StartMarketingDate>
    <EndMarketingDate>20240430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040730</ApplicationNumber>
    <LabelerName>Henry Schein, Inc.</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221014</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.</IndicationAndUsage>
    <Description>Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride USP, 20 mg. Preservatives: Methylparaben NF, 0.65 mg; Propylparaben NF, 0.35 mg. Inactives: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid USP to adjust pH (3.4 to 4.4) and Water for Injection. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64.</Description>
  </NDC>
  <NDC>
    <NDCCode>0404-9994-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9994-01)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00404-9994-01</NDC11Code>
    <ProductNDC>0404-9994</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20230717</StartMarketingDate>
    <EndMarketingDate>20260131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213667</ApplicationNumber>
    <LabelerName>Henry Schein, Inc.</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230717</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.</IndicationAndUsage>
    <Description>Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride USP, 20 mg. Preservative Free Formulation. Inactives: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid USP to adjust pH (3.4 to 4.4) and Water for Injection. Hydralazine Hydrochloride USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-3294-25</NDCCode>
    <PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-25)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-15) </PackageDescription>
    <NDC11Code>00409-3294-25</NDC11Code>
    <ProductNDC>0409-3294</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Acetate</ProprietaryName>
    <NonProprietaryName>Potassium Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20131223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018896</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>POTASSIUM ACETATE</SubstanceName>
    <StrengthNumber>196.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.</IndicationAndUsage>
    <Description>Potassium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of potassium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 196 mg of potassium acetate which provides 2 mEq each of potassium (K+) and acetate (CH3COO¯). The solution may contain acetic acid for pH adjustment. The pH is 6.2 (range: 5.5 to 8.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity is 1.089. The Pharmacy Bulk Package is a sterile dosage which contains multiple single doses for use only in a pharmacy bulk admixture program. The solution is intended as an alternative to potassium chloride to provide potassium ion (K+) for addition to large volume infusion fluids for intravenous use. Potassium Acetate, USP is chemically designated CH3COOK, and is comprised of colorless crystals or a white crystalline powder that is very soluble in water. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures. The Pharmacy Bulk Package contains no bacteriostat, antimicrobial agent, or added buffer. Multiple single doses may be dispensed during continual aliquoting operations.</Description>
  </NDC>
  <NDC>
    <NDCCode>0409-3294-51</NDCCode>
    <PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-51)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-61) </PackageDescription>
    <NDC11Code>00409-3294-51</NDC11Code>
    <ProductNDC>0409-3294</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Acetate</ProprietaryName>
    <NonProprietaryName>Potassium Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20050705</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018896</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>POTASSIUM ACETATE</SubstanceName>
    <StrengthNumber>196.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050705</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.</IndicationAndUsage>
    <Description>Potassium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of potassium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 196 mg of potassium acetate which provides 2 mEq each of potassium (K+) and acetate (CH3COO-). The solution may contain acetic acid for pH adjustment. The pH is 6.2 (range: 5.5 to 8.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity is 1.089. The Pharmacy Bulk Package is a sterile dosage which contains multiple single doses for use only in a pharmacy bulk admixture program. The solution is intended as an alternative to potassium chloride to provide potassium ion (K+) for addition to large volume infusion fluids for intravenous use. Potassium Acetate, USP is chemically designated CH3COOK, and is comprised of colorless crystals or a white crystalline powder that is very soluble in water. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures. The Pharmacy Bulk Package contains no bacteriostat, antimicrobial agent, or added buffer. Multiple single doses may be dispensed during continual aliquoting operations.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-0901-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25)  &gt; 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-0901-25</NDC11Code>
    <ProductNDC>0517-0901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19970630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040136</ApplicationNumber>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-05-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19970630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.</IndicationAndUsage>
    <Description>HydrALAZINE Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Each milliliter of the sterile, nonpyrogenic colorless solution contains Hydralazine Hydrochloride, 20 mg, Methylparaben, 0.65 mg, Propylparaben, 0.35 mg, Propylene Glycol, 103.6 mg, and Water for Injection q.s. The pH of the solution is 3.4 to 4.4. pH may be adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Hydralazine Hydrochloride is 1-Hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula C8H8N4HCl. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64.</Description>
  </NDC>
  <NDC>
    <NDCCode>0517-2053-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2053-25)  &gt; 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00517-2053-25</NDC11Code>
    <ProductNDC>0517-2053</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Acetate</ProprietaryName>
    <NonProprietaryName>Potassium Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>American Regent, Inc.</LabelerName>
    <SubstanceName>POTASSIUM ACETATE</SubstanceName>
    <StrengthNumber>196</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-20</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0527-1329-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0527-1329-01) </PackageDescription>
    <NDC11Code>00527-1329-01</NDC11Code>
    <ProductNDC>0527-1329</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bethanechol Chloride</ProprietaryName>
    <NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040677</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
    <Description>Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&amp;C Yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1332-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0527-1332-01) </PackageDescription>
    <NDC11Code>00527-1332-01</NDC11Code>
    <ProductNDC>0527-1332</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bethanechol Chloride</ProprietaryName>
    <NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040677</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
    <Description>Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&amp;C Yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1340-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0527-1340-01) </PackageDescription>
    <NDC11Code>00527-1340-01</NDC11Code>
    <ProductNDC>0527-1340</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bethanechol Chloride</ProprietaryName>
    <NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040677</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
    <Description>Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&amp;C Yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1356-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0527-1356-01) </PackageDescription>
    <NDC11Code>00527-1356-01</NDC11Code>
    <ProductNDC>0527-1356</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bethanechol Chloride</ProprietaryName>
    <NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040677</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
    <Description>Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&amp;C Yellow No. 10 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0615-7973-05</NDCCode>
    <PackageDescription>15 TABLET in 1 BLISTER PACK (0615-7973-05) </PackageDescription>
    <NDC11Code>00615-7973-05</NDC11Code>
    <ProductNDC>0615-7973</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040901</ApplicationNumber>
    <LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGE:  Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
    <Description>DESCRIPTION:  HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275ºC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&amp;C Yellow # 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>0615-7973-39</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (0615-7973-39) </PackageDescription>
    <NDC11Code>00615-7973-39</NDC11Code>
    <ProductNDC>0615-7973</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040901</ApplicationNumber>
    <LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGE:  Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
    <Description>DESCRIPTION:  HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275ºC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&amp;C Yellow # 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>0641-6231-25</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25)  / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01) </PackageDescription>
    <NDC11Code>00641-6231-25</NDC11Code>
    <ProductNDC>0641-6231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20201218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213667</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.</IndicationAndUsage>
    <Description>Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride USP, 20 mg. Preservative Free Formulation. Inactives: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid USP to adjust pH (3.4 to  4.4) and Water for Injection. Hydralazine Hydrochloride USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula: C8H8N4HCl. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64.</Description>
  </NDC>
  <NDC>
    <NDCCode>0703-3671-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-01)  / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00703-3671-01</NDC11Code>
    <ProductNDC>0703-3671</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methotrexate</ProprietaryName>
    <NonProprietaryName>Methotrexate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS</RouteName>
    <StartMarketingDate>20120731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040843</ApplicationNumber>
    <LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
    <SubstanceName>METHOTREXATE SODIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).</IndicationAndUsage>
    <Description>Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5            M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>41250-196-46</NDCCode><ProprietaryName>Miconazole Nitrate</ProprietaryName><NonProprietaryName>Athletes Foot Powder Spray Talc Free</NonProprietaryName></NDC><NDC><NDCCode>55319-196-46</NDCCode><ProprietaryName>Tolnafate</ProprietaryName><NonProprietaryName>Tolnaftate Powder Spray</NonProprietaryName></NDC><NDC><NDCCode>41250-563-46</NDCCode><ProprietaryName>Tolnaftate</ProprietaryName><NonProprietaryName>Tolnaftate Jock Itch Powder Spray - Talc Free</NonProprietaryName></NDC><NDC><NDCCode>41250-954-46</NDCCode><ProprietaryName>Allergy Relief D</ProprietaryName><NonProprietaryName>Loratadine, Pseudoephedrine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>21695-196-01</NDCCode><ProprietaryName>Advair</ProprietaryName><NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName></NDC><NDC><NDCCode>41250-163-08</NDCCode><ProprietaryName>Antibacterial Foaming</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>41250-177-08</NDCCode><ProprietaryName>Antibacterial Foaming</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>41250-177-32</NDCCode><ProprietaryName>Antibacterial Foaming</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>41250-186-08</NDCCode><ProprietaryName>Antibacterial Foaming</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>41250-808-96</NDCCode><ProprietaryName>Foaming Hand Wash</ProprietaryName><NonProprietaryName>Triclosan 0.46%</NonProprietaryName></NDC><NDC><NDCCode>41250-962-45</NDCCode><ProprietaryName>Foaming Hand Wash</ProprietaryName><NonProprietaryName>Triclosan 0.46%</NonProprietaryName></NDC><NDC><NDCCode>41250-962-96</NDCCode><ProprietaryName>Foaming Hand Wash</ProprietaryName><NonProprietaryName>Triclosan 0.46%</NonProprietaryName></NDC><NDC><NDCCode>0019-5505-06</NDCCode><ProprietaryName>Hexabrix</ProprietaryName><NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName></NDC><NDC><NDCCode>0019-5505-08</NDCCode><ProprietaryName>Hexabrix</ProprietaryName><NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName></NDC><NDC><NDCCode>0019-5505-21</NDCCode><ProprietaryName>Hexabrix</ProprietaryName><NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName></NDC><NDC><NDCCode>0019-5505-51</NDCCode><ProprietaryName>Hexabrix</ProprietaryName><NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName></NDC><NDC><NDCCode>0404-9986-20</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0404-9994-01</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0409-3294-25</NDCCode><ProprietaryName>Potassium Acetate</ProprietaryName><NonProprietaryName>Potassium Acetate</NonProprietaryName></NDC><NDC><NDCCode>0409-3294-51</NDCCode><ProprietaryName>Potassium Acetate</ProprietaryName><NonProprietaryName>Potassium Acetate</NonProprietaryName></NDC><NDC><NDCCode>0517-0901-25</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0517-2053-25</NDCCode><ProprietaryName>Potassium Acetate</ProprietaryName><NonProprietaryName>Potassium Acetate</NonProprietaryName></NDC><NDC><NDCCode>0527-1329-01</NDCCode><ProprietaryName>Bethanechol Chloride</ProprietaryName><NonProprietaryName>Bethanechol Chloride</NonProprietaryName></NDC><NDC><NDCCode>0527-1332-01</NDCCode><ProprietaryName>Bethanechol Chloride</ProprietaryName><NonProprietaryName>Bethanechol Chloride</NonProprietaryName></NDC><NDC><NDCCode>0527-1340-01</NDCCode><ProprietaryName>Bethanechol Chloride</ProprietaryName><NonProprietaryName>Bethanechol Chloride</NonProprietaryName></NDC><NDC><NDCCode>0527-1356-01</NDCCode><ProprietaryName>Bethanechol Chloride</ProprietaryName><NonProprietaryName>Bethanechol Chloride</NonProprietaryName></NDC><NDC><NDCCode>0615-7973-05</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0615-7973-39</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0641-6231-25</NDCCode><ProprietaryName>Hydralazine Hydrochloride</ProprietaryName><NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0703-3671-01</NDCCode><ProprietaryName>Methotrexate</ProprietaryName><NonProprietaryName>Methotrexate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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