RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (38 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "49348-186-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49348-186-20)  / 133 mL in 1 BOTTLE",
      "NDC11Code": "49348-0186-20",
      "ProductNDC": "49348-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark Saline Single",
      "ProprietaryNameSuffix": "Laxative",
      "NonProprietaryName": "Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form",
      "DosageFormName": "ENEMA",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20130306",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "Strategic Sourcing Services LLC",
      "SubstanceName": "SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM",
      "StrengthNumber": "7; 19",
      "StrengthUnit": "g/118mL; g/118mL",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130306",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49348-186-14",
      "PackageDescription": "2 BOTTLE in 1 CARTON (49348-186-14)  / 133 mL in 1 BOTTLE",
      "NDC11Code": "49348-0186-14",
      "ProductNDC": "49348-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark Saline Single",
      "ProprietaryNameSuffix": "Laxative",
      "NonProprietaryName": "Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form",
      "DosageFormName": "ENEMA",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20130306",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "Strategic Sourcing Services LLC",
      "SubstanceName": "SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM",
      "StrengthNumber": "7; 19",
      "StrengthUnit": "g/118mL; g/118mL",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130306",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49348-097-47",
      "PackageDescription": "20 TABLET, SUGAR COATED in 1 BLISTER PACK (49348-097-47) ",
      "NDC11Code": "49348-0097-47",
      "ProductNDC": "49348-097",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen And Pseudoephedrine Hydrochloride",
      "NonProprietaryName": "Ibuprofen And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20011013",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074567",
      "LabelerName": "Sunmark",
      "SubstanceName": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "200; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20011013",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms associated with the common cold or flu: 1 headache, 2 fever, 3 sinus pressure, 4 nasal congestion, 5 minor body aches and pains."
    },
    {
      "NDCCode": "49348-185-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49348-185-20)  / 133 mL in 1 BOTTLE",
      "NDC11Code": "49348-0185-20",
      "ProductNDC": "49348-185",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark Mineral Oil",
      "ProprietaryNameSuffix": "Laxative",
      "NonProprietaryName": "Mineral Oil",
      "DosageFormName": "ENEMA",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20021113",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "Strategic Sourcing Services",
      "SubstanceName": "MINERAL OIL",
      "StrengthNumber": "118",
      "StrengthUnit": "g/118mL",
      "Status": "Active",
      "LastUpdate": "2025-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20021113",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional constipation."
    },
    {
      "NDCCode": "49348-527-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49348-527-20)  > 133 mL in 1 BOTTLE",
      "NDC11Code": "49348-0527-20",
      "ProductNDC": "49348-527",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark Enema",
      "NonProprietaryName": "Saline",
      "DosageFormName": "ENEMA",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20091118",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "McKesson",
      "SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
      "StrengthNumber": "7; 19",
      "StrengthUnit": "g/118mL; g/118mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "49348-568-47",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49348-568-47)  > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE",
      "NDC11Code": "49348-0568-47",
      "ProductNDC": "49348-568",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100709",
      "EndMarketingDate": "20191231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078682",
      "LabelerName": "McKesson (Sunmark)",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100709",
      "EndMarketingDatePackage": "20191231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49348-864-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49348-864-20)  > 133 mL in 1 BOTTLE",
      "NDC11Code": "49348-0864-20",
      "ProductNDC": "49348-864",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark",
      "NonProprietaryName": "Saline Laxative",
      "DosageFormName": "ENEMA",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20130306",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Mckesson Corporation",
      "SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
      "StrengthNumber": "7; 19",
      "StrengthUnit": "g/118mL; g/118mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "relieves occasional constipation."
    },
    {
      "NDCCode": "49348-880-20",
      "PackageDescription": "1 BOTTLE in 1 BOX (49348-880-20)  > 133 mL in 1 BOTTLE",
      "NDC11Code": "49348-0880-20",
      "ProductNDC": "49348-880",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark Mineral Oil",
      "NonProprietaryName": "Mineral Oil",
      "DosageFormName": "ENEMA",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Mckesson Corporation",
      "SubstanceName": "MINERAL OIL",
      "StrengthNumber": "118",
      "StrengthUnit": "mL/118mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "for relief of occasional constipation."
    },
    {
      "NDCCode": "49348-905-47",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49348-905-47)  > 20 TABLET, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "49348-0905-47",
      "ProductNDC": "49348-905",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark Mucus Er",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130318",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078912",
      "LabelerName": "McKesson",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "25021-186-20",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-186-20)  > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "25021-0186-20",
      "ProductNDC": "25021-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin And Sulbactam",
      "NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20170815",
      "EndMarketingDate": "20210331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090579",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
      "StrengthNumber": "1; .5",
      "StrengthUnit": "g/1; g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170815",
      "EndMarketingDatePackage": "20210331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42023-186-20",
      "PackageDescription": "20 VIAL in 1 CARTON (42023-186-20)  / 50 mL in 1 VIAL",
      "NDC11Code": "42023-0186-20",
      "ProductNDC": "42023-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexmedetomidine Hydrochloride",
      "NonProprietaryName": "Dexmedetomidine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208266",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20201204",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
      "Description": "Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0.  Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection.  The solution is preservative-free and contains no additives or chemical stabilizers."
    },
    {
      "NDCCode": "42851-186-60",
      "PackageDescription": "1 KIT in 1 CARTON (42851-186-60)  *  16.2 g in 1 JAR *  30 mL in 1 BOTTLE *  60 PATCH in 1 JAR > .8 mL in 1 PATCH *  20 mL in 1 TUBE *  60 mL in 1 TUBE *  9 mL in 1 VIAL, GLASS",
      "NDC11Code": "42851-0186-60",
      "ProductNDC": "42851-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zo Skin Health Skin Normalizing System With Rozatrol Booster Serum",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20180501",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "ZO Skin Health, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180501",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the management of acne. Penetrates pores to control acne blemishes."
    },
    {
      "NDCCode": "54111-186-20",
      "PackageDescription": "20 mL in 1 TUBE (54111-186-20) ",
      "NDC11Code": "54111-0186-20",
      "ProductNDC": "54111-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tinted Face Cream",
      "ProprietaryNameSuffix": "Spf 15",
      "NonProprietaryName": "Octocrylene, Octisalate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230718",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Bentley Laboratories, LLC",
      "SubstanceName": "OCTOCRYLENE; OCTISALATE",
      "StrengthNumber": "5; 2",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2024-12-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230718",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses Helps prevent sunburn  if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early signs of skin aging from the sun."
    },
    {
      "NDCCode": "55289-186-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (55289-186-20) ",
      "NDC11Code": "55289-0186-20",
      "ProductNDC": "55289-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin (macrocrystals)",
      "NonProprietaryName": "Nitrofurantoin (macrocrystals)",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970909",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074967",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20061128",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58411-186-20",
      "PackageDescription": "1 CONTAINER in 1 CARTON (58411-186-20)  > 10 g in 1 CONTAINER",
      "NDC11Code": "58411-0186-20",
      "ProductNDC": "58411-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shiseido The Makeup Foundation",
      "ProprietaryNameSuffix": "B20",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SHISEIDO AMERICAS CORPORATION",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "410",
      "StrengthUnit": "mg/10g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20140601",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63323-186-20",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-186-20)  > 20 mL in 1 VIAL, SINGLE-DOSE (63323-186-03) ",
      "NDC11Code": "63323-0186-20",
      "ProductNDC": "63323-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20000810",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088912",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000810",
      "SamplePackage": "N",
      "IndicationAndUsage": "This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.",
      "Description": "This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic solution. The osmolarity is 0.300 mOsmol/mL (calculated). Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0). Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44."
    },
    {
      "NDCCode": "64220-186-07",
      "PackageDescription": "20 kg in 1 DRUM (64220-186-07)",
      "NDC11Code": "64220-0186-07",
      "ProductNDC": "64220-186",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gefitinib",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150107",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
      "SubstanceName": "GEFITINIB",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "71052-186-20",
      "PackageDescription": "1000 g in 1 BOTTLE (71052-186-20) ",
      "NDC11Code": "71052-0186-20",
      "ProductNDC": "71052-186",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tylosin Tartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170601",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Darmerica, LLC",
      "SubstanceName": "TYLOSIN TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "01-JUN-17"
    },
    {
      "NDCCode": "71205-186-20",
      "PackageDescription": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-186-20) ",
      "NDC11Code": "71205-0186-20",
      "ProductNDC": "71205-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080417",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078321",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2022-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, copovidone, hypromellose, magnesium stearate and microcrystalline cellulose. The USP dissolution test is pending."
    },
    {
      "NDCCode": "71288-186-20",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-186-20)  / 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "71288-0186-20",
      "ProductNDC": "71288-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Idarubicin Hydrochloride",
      "NonProprietaryName": "Idarubicin Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065036",
      "LabelerName": "Meitheal Pharmaceuticals Inc.",
      "SubstanceName": "IDARUBICIN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.",
      "Description": "Idarubicin Hydrochloride Injection, USP contains idarubicin hydrochloride, USP and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride, USP is 5, 12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows. C26H27NO9HCl          M.W. 533.95. Idarubicin Hydrochloride Injection, USP is a sterile, clear, orange-red, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-dose-only vials. Each mL contains idarubicin hydrochloride USP, 1 mg (equivalent to 0.93 mg idarubicin free base) and the following inactive ingredients: glycerin USP, 25 mg and q.s. water for injection, USP. Hydrochloric acid and/or sodium hydroxide is used to adjust pH to a target of 3.5."
    },
    {
      "NDCCode": "79794-186-04",
      "PackageDescription": "24 CANISTER in 1 BOX (79794-186-04)  / 20 CLOTH in 1 CANISTER",
      "NDC11Code": "79794-0186-04",
      "ProductNDC": "79794-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Hand Wipes (angel)",
      "NonProprietaryName": "Antibacterial Hand Wipes",
      "DosageFormName": "CLOTH",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20260806",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/1",
      "Status": "Active",
      "LastUpdate": "2026-08-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260806",
      "SamplePackage": "N",
      "IndicationAndUsage": "when using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If irritation or rash occurs, stop use and ask a doctor, if swallowed, get medical help or contact a Poison Control Center right way."
    },
    {
      "NDCCode": "79903-186-20",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (79903-186-20)  / 20 TABLET, COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "79903-0186-20",
      "ProductNDC": "79903-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen Pm",
      "NonProprietaryName": "Diphenhydramine Citrate, Ibuprofen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240608",
      "EndMarketingDate": "20271228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211404",
      "LabelerName": "WALMART INC. (see also Equate)",
      "SubstanceName": "IBUPROFEN; DIPHENHYDRAMINE CITRATE",
      "StrengthNumber": "200; 38",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240608",
      "EndMarketingDatePackage": "20271228",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional sleeplessness when associated with minor aches and pains . helps you fall asleep and stay asleep."
    },
    {
      "NDCCode": "0409-1005-20",
      "PackageDescription": "20 POUCH in 1 CASE (0409-1005-20)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0409-1005-01) ",
      "NDC11Code": "00409-1005-20",
      "ProductNDC": "0409-1005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Heparin Sodium",
      "NonProprietaryName": "Heparin Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230227",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018916",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "HEPARIN SODIUM",
      "StrengthNumber": "200",
      "StrengthUnit": "[USP'U]/100mL",
      "Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.",
      "Description": "Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, monohydrate, 40 mg and dibasic sodium phosphate, heptahydrate, 434 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.4 mEq; phosphate (as HPO4=) 32.4 mEq, citrate 5.7 mEq and chloride 154 mEq. Osmolar concentration, 378 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Dibasic Sodium Phosphate, USP (heptahydrate), is chemically designated (Na2HPO4 ∙ 7H2O), colorless or white granular salt freely soluble in water. Citric Acid, USP, hydrous (monohydrate) is chemically designated C6H8O7 ∙ H2O, colorless, translucent crystals or white crystalline powder very soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from either polyvinylchloride or polyolefin plastic. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
    },
    {
      "NDCCode": "11673-186-40",
      "PackageDescription": "355 mL in 1 BOTTLE (11673-186-40) ",
      "NDC11Code": "11673-0186-40",
      "ProductNDC": "11673-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Nighttime Sleep Aid",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200326",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M010",
      "LabelerName": "Target Corporation",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/30mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200326",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
    },
    {
      "NDCCode": "16477-186-01",
      "PackageDescription": "473 mL in 1 BOTTLE (16477-186-01)",
      "NDC11Code": "16477-0186-01",
      "ProductNDC": "16477-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Donatussin",
      "NonProprietaryName": "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140219",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Laser Pharmaceuticals, LLC",
      "SubstanceName": "CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "4; 20; 10",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-29"
    },
    {
      "NDCCode": "21695-186-05",
      "PackageDescription": "5 mL in 1 BOTTLE (21695-186-05)",
      "NDC11Code": "21695-0186-05",
      "ProductNDC": "21695-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfacetamide Sodium And Prednisolone Sodium Phosphate",
      "NonProprietaryName": "Sulfacetamide Sodium And Prednisolone Sodium Phosphate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19951229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074449",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE",
      "StrengthNumber": "100; 2.5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.",
      "Description": "Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is a sterile topical ophthalmic solution combining an antibacterial and a corticosteroid. Each mL Contains: Actives: sulfacetamide sodium (as the monohydrate) 100 mg, prednisolone sodium phosphate 2.5 mg (equivalent to prednisolone phosphate 2.3 mg). Preservative: thimerosal 0.1 mg. Inactives: edetate disodium, poloxamer 407, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection. pH range is 6.5 to 7.5. The chemical name for sulfacetamide sodium, is N-sulfanilylacetamide monosodium salt monohydrate. The chemical name for prednisolone sodium phosphate is 11β,17,21-trihydroxypregna-1,4-diene-3,20-dione,21-(disodium phosphate). They have the following chemical structures."
    },
    {
      "NDCCode": "31722-186-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-186-01) ",
      "NDC11Code": "31722-0186-01",
      "ProductNDC": "31722-186",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210929",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214959",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "2.5; 2.5; 2.5; 2.5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-10-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210929",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red. The 5 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulfate and D&C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD & C Blue 1, D & C Red 28, gelatin and sodium lauryl sulfate. The 20 mg capsule shell contain Titanium dioxide, FD & C Red 3, FD & C Yellow 6, FD & C Blue 1, gelatin, sodium lauryl sulfate and FD & C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD & C Red 40, FD & C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD & C Yellow 6, D & C Yellow 10, sodium lauryl sulfate and gelatin. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide."
    },
    {
      "NDCCode": "36800-186-37",
      "PackageDescription": "156 g in 1 CAN (36800-186-37) ",
      "NDC11Code": "36800-0186-37",
      "ProductNDC": "36800-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Everyday Sport Continuous Broad Spectrum Spf 30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octocrylene,",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181220",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "TOPCO ASSOCIATES LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE",
      "StrengthNumber": "20; 70; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181220",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "36800-186-62",
      "PackageDescription": "3 CAN in 1 PACKAGE (36800-186-62)  / 156 g in 1 CAN (36800-186-37) ",
      "NDC11Code": "36800-0186-62",
      "ProductNDC": "36800-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Everyday Sport Continuous Broad Spectrum Spf 30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octocrylene,",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181220",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "TOPCO ASSOCIATES LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE",
      "StrengthNumber": "20; 70; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181220",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "36800-186-63",
      "PackageDescription": "2 CAN in 1 PACKAGE (36800-186-63)  / 156 g in 1 CAN (36800-186-37) ",
      "NDC11Code": "36800-0186-63",
      "ProductNDC": "36800-186",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare Everyday Sport Continuous Broad Spectrum Spf 30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octocrylene,",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181220",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "TOPCO ASSOCIATES LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE",
      "StrengthNumber": "20; 70; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181220",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun ."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"49348-186-20","ProprietaryName":"Sunmark Saline Single","NonProprietaryName":"Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form"},{"NDCCode":"49348-186-14","ProprietaryName":"Sunmark Saline Single","NonProprietaryName":"Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form"},{"NDCCode":"49348-097-47","ProprietaryName":"Ibuprofen And Pseudoephedrine Hydrochloride","NonProprietaryName":"Ibuprofen And Pseudoephedrine Hydrochloride"},{"NDCCode":"49348-185-20","ProprietaryName":"Sunmark Mineral Oil","NonProprietaryName":"Mineral Oil"},{"NDCCode":"49348-527-20","ProprietaryName":"Sunmark Enema","NonProprietaryName":"Saline"},{"NDCCode":"49348-568-47","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"49348-864-20","ProprietaryName":"Sunmark","NonProprietaryName":"Saline Laxative"},{"NDCCode":"49348-880-20","ProprietaryName":"Sunmark Mineral Oil","NonProprietaryName":"Mineral Oil"},{"NDCCode":"49348-905-47","ProprietaryName":"Sunmark Mucus Er","NonProprietaryName":"Guaifenesin"},{"NDCCode":"25021-186-20","ProprietaryName":"Ampicillin And Sulbactam","NonProprietaryName":"Ampicillin Sodium And Sulbactam Sodium"},{"NDCCode":"42023-186-20","ProprietaryName":"Dexmedetomidine Hydrochloride","NonProprietaryName":"Dexmedetomidine Hydrochloride"},{"NDCCode":"42851-186-60","ProprietaryName":"Zo Skin Health Skin Normalizing System With Rozatrol Booster Serum","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"54111-186-20","ProprietaryName":"Tinted Face Cream","NonProprietaryName":"Octocrylene, Octisalate"},{"NDCCode":"55289-186-20","ProprietaryName":"Nitrofurantoin (macrocrystals)","NonProprietaryName":"Nitrofurantoin (macrocrystals)"},{"NDCCode":"58411-186-20","ProprietaryName":"Shiseido The Makeup Foundation","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"63323-186-20","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"64220-186-07","NonProprietaryName":"Gefitinib"},{"NDCCode":"71052-186-20","NonProprietaryName":"Tylosin Tartrate"},{"NDCCode":"71205-186-20","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"71288-186-20","ProprietaryName":"Idarubicin Hydrochloride","NonProprietaryName":"Idarubicin Hydrochloride"},{"NDCCode":"79794-186-04","ProprietaryName":"Antibacterial Hand Wipes (angel)","NonProprietaryName":"Antibacterial Hand Wipes"},{"NDCCode":"79903-186-20","ProprietaryName":"Ibuprofen Pm","NonProprietaryName":"Diphenhydramine Citrate, Ibuprofen"},{"NDCCode":"0409-1005-20","ProprietaryName":"Heparin Sodium","NonProprietaryName":"Heparin Sodium"},{"NDCCode":"11673-186-40","ProprietaryName":"Up And Up Nighttime Sleep Aid","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"16477-186-01","ProprietaryName":"Donatussin","NonProprietaryName":"Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"},{"NDCCode":"21695-186-05","ProprietaryName":"Sulfacetamide Sodium And Prednisolone Sodium Phosphate","NonProprietaryName":"Sulfacetamide Sodium And Prednisolone Sodium Phosphate"},{"NDCCode":"31722-186-01","ProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate"},{"NDCCode":"36800-186-37","ProprietaryName":"Topcare Everyday Sport Continuous Broad Spectrum Spf 30","NonProprietaryName":"Avobenzone, Homosalate, Octocrylene,"},{"NDCCode":"36800-186-62","ProprietaryName":"Topcare Everyday Sport Continuous Broad Spectrum Spf 30","NonProprietaryName":"Avobenzone, Homosalate, Octocrylene,"},{"NDCCode":"36800-186-63","ProprietaryName":"Topcare Everyday Sport Continuous Broad Spectrum Spf 30","NonProprietaryName":"Avobenzone, Homosalate, Octocrylene,"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>49348-186-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-186-20)  / 133 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0186-20</NDC11Code>
    <ProductNDC>49348-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Saline Single</ProprietaryName>
    <ProprietaryNameSuffix>Laxative</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form</NonProprietaryName>
    <DosageFormName>ENEMA</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20130306</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Strategic Sourcing Services LLC</LabelerName>
    <SubstanceName>SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>7; 19</StrengthNumber>
    <StrengthUnit>g/118mL; g/118mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49348-186-14</NDCCode>
    <PackageDescription>2 BOTTLE in 1 CARTON (49348-186-14)  / 133 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0186-14</NDC11Code>
    <ProductNDC>49348-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Saline Single</ProprietaryName>
    <ProprietaryNameSuffix>Laxative</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form</NonProprietaryName>
    <DosageFormName>ENEMA</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20130306</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Strategic Sourcing Services LLC</LabelerName>
    <SubstanceName>SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>7; 19</StrengthNumber>
    <StrengthUnit>g/118mL; g/118mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49348-097-47</NDCCode>
    <PackageDescription>20 TABLET, SUGAR COATED in 1 BLISTER PACK (49348-097-47) </PackageDescription>
    <NDC11Code>49348-0097-47</NDC11Code>
    <ProductNDC>49348-097</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen And Pseudoephedrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ibuprofen And Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, SUGAR COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20011013</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074567</ApplicationNumber>
    <LabelerName>Sunmark</LabelerName>
    <SubstanceName>IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20011013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms associated with the common cold or flu: 1 headache, 2 fever, 3 sinus pressure, 4 nasal congestion, 5 minor body aches and pains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49348-185-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-185-20)  / 133 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0185-20</NDC11Code>
    <ProductNDC>49348-185</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Mineral Oil</ProprietaryName>
    <ProprietaryNameSuffix>Laxative</ProprietaryNameSuffix>
    <NonProprietaryName>Mineral Oil</NonProprietaryName>
    <DosageFormName>ENEMA</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20021113</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Strategic Sourcing Services</LabelerName>
    <SubstanceName>MINERAL OIL</SubstanceName>
    <StrengthNumber>118</StrengthNumber>
    <StrengthUnit>g/118mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20021113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional constipation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49348-527-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-527-20)  &gt; 133 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0527-20</NDC11Code>
    <ProductNDC>49348-527</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Enema</ProprietaryName>
    <NonProprietaryName>Saline</NonProprietaryName>
    <DosageFormName>ENEMA</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20091118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>McKesson</LabelerName>
    <SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
    <StrengthNumber>7; 19</StrengthNumber>
    <StrengthUnit>g/118mL; g/118mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49348-568-47</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-568-47)  &gt; 20 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0568-47</NDC11Code>
    <ProductNDC>49348-568</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100709</StartMarketingDate>
    <EndMarketingDate>20191231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078682</ApplicationNumber>
    <LabelerName>McKesson (Sunmark)</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100709</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49348-864-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-864-20)  &gt; 133 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0864-20</NDC11Code>
    <ProductNDC>49348-864</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark</ProprietaryName>
    <NonProprietaryName>Saline Laxative</NonProprietaryName>
    <DosageFormName>ENEMA</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20130306</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Mckesson Corporation</LabelerName>
    <SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
    <StrengthNumber>7; 19</StrengthNumber>
    <StrengthUnit>g/118mL; g/118mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>relieves occasional constipation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49348-880-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (49348-880-20)  &gt; 133 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0880-20</NDC11Code>
    <ProductNDC>49348-880</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Mineral Oil</ProprietaryName>
    <NonProprietaryName>Mineral Oil</NonProprietaryName>
    <DosageFormName>ENEMA</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20130801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Mckesson Corporation</LabelerName>
    <SubstanceName>MINERAL OIL</SubstanceName>
    <StrengthNumber>118</StrengthNumber>
    <StrengthUnit>mL/118mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for relief of occasional constipation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49348-905-47</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-905-47)  &gt; 20 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0905-47</NDC11Code>
    <ProductNDC>49348-905</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Mucus Er</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078912</ApplicationNumber>
    <LabelerName>McKesson</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>25021-186-20</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-186-20)  &gt; 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0186-20</NDC11Code>
    <ProductNDC>25021-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
    <NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20170815</StartMarketingDate>
    <EndMarketingDate>20210331</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090579</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
    <StrengthNumber>1; .5</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170815</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42023-186-20</NDCCode>
    <PackageDescription>20 VIAL in 1 CARTON (42023-186-20)  / 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42023-0186-20</NDC11Code>
    <ProductNDC>42023-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208266</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
    <Description>Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2  HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection, USP is intended to be used after dilution. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0.  Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection.  The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
  </NDC>
  <NDC>
    <NDCCode>42851-186-60</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (42851-186-60)  *  16.2 g in 1 JAR *  30 mL in 1 BOTTLE *  60 PATCH in 1 JAR &gt; .8 mL in 1 PATCH *  20 mL in 1 TUBE *  60 mL in 1 TUBE *  9 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>42851-0186-60</NDC11Code>
    <ProductNDC>42851-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zo Skin Health Skin Normalizing System With Rozatrol Booster Serum</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20180501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the management of acne. Penetrates pores to control acne blemishes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54111-186-20</NDCCode>
    <PackageDescription>20 mL in 1 TUBE (54111-186-20) </PackageDescription>
    <NDC11Code>54111-0186-20</NDC11Code>
    <ProductNDC>54111-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tinted Face Cream</ProprietaryName>
    <ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
    <NonProprietaryName>Octocrylene, Octisalate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230718</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Bentley Laboratories, LLC</LabelerName>
    <SubstanceName>OCTOCRYLENE; OCTISALATE</SubstanceName>
    <StrengthNumber>5; 2</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Helps prevent sunburn  if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early signs of skin aging from the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55289-186-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (55289-186-20) </PackageDescription>
    <NDC11Code>55289-0186-20</NDC11Code>
    <ProductNDC>55289-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin (macrocrystals)</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin (macrocrystals)</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970909</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074967</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NITROFURANTOIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58411-186-20</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (58411-186-20)  &gt; 10 g in 1 CONTAINER</PackageDescription>
    <NDC11Code>58411-0186-20</NDC11Code>
    <ProductNDC>58411-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shiseido The Makeup Foundation</ProprietaryName>
    <ProprietaryNameSuffix>B20</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>410</StrengthNumber>
    <StrengthUnit>mg/10g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-186-20</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-186-20)  &gt; 20 mL in 1 VIAL, SINGLE-DOSE (63323-186-03) </PackageDescription>
    <NDC11Code>63323-0186-20</NDC11Code>
    <ProductNDC>63323-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20000810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088912</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.</IndicationAndUsage>
    <Description>This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic solution. The osmolarity is 0.300 mOsmol/mL (calculated). Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0). Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.</Description>
  </NDC>
  <NDC>
    <NDCCode>64220-186-07</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (64220-186-07)</PackageDescription>
    <NDC11Code>64220-0186-07</NDC11Code>
    <ProductNDC>64220-186</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gefitinib</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150107</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>GEFITINIB</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>71052-186-20</NDCCode>
    <PackageDescription>1000 g in 1 BOTTLE (71052-186-20) </PackageDescription>
    <NDC11Code>71052-0186-20</NDC11Code>
    <ProductNDC>71052-186</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tylosin Tartrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Darmerica, LLC</LabelerName>
    <SubstanceName>TYLOSIN TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JUN-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>71205-186-20</NDCCode>
    <PackageDescription>20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-186-20) </PackageDescription>
    <NDC11Code>71205-0186-20</NDC11Code>
    <ProductNDC>71205-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078321</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, copovidone, hypromellose, magnesium stearate and microcrystalline cellulose. The USP dissolution test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>71288-186-20</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-186-20)  / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>71288-0186-20</NDC11Code>
    <ProductNDC>71288-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Idarubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Idarubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065036</ApplicationNumber>
    <LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>IDARUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.</IndicationAndUsage>
    <Description>Idarubicin Hydrochloride Injection, USP contains idarubicin hydrochloride, USP and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride, USP is 5, 12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows. C26H27NO9HCl          M.W. 533.95. Idarubicin Hydrochloride Injection, USP is a sterile, clear, orange-red, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-dose-only vials. Each mL contains idarubicin hydrochloride USP, 1 mg (equivalent to 0.93 mg idarubicin free base) and the following inactive ingredients: glycerin USP, 25 mg and q.s. water for injection, USP. Hydrochloric acid and/or sodium hydroxide is used to adjust pH to a target of 3.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>79794-186-04</NDCCode>
    <PackageDescription>24 CANISTER in 1 BOX (79794-186-04)  / 20 CLOTH in 1 CANISTER</PackageDescription>
    <NDC11Code>79794-0186-04</NDC11Code>
    <ProductNDC>79794-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Hand Wipes (angel)</ProprietaryName>
    <NonProprietaryName>Antibacterial Hand Wipes</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20260806</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>when using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If irritation or rash occurs, stop use and ask a doctor, if swallowed, get medical help or contact a Poison Control Center right way.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79903-186-20</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (79903-186-20)  / 20 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>79903-0186-20</NDC11Code>
    <ProductNDC>79903-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen Pm</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240608</StartMarketingDate>
    <EndMarketingDate>20271228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211404</ApplicationNumber>
    <LabelerName>WALMART INC. (see also Equate)</LabelerName>
    <SubstanceName>IBUPROFEN; DIPHENHYDRAMINE CITRATE</SubstanceName>
    <StrengthNumber>200; 38</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240608</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional sleeplessness when associated with minor aches and pains . helps you fall asleep and stay asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0409-1005-20</NDCCode>
    <PackageDescription>20 POUCH in 1 CASE (0409-1005-20)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0409-1005-01) </PackageDescription>
    <NDC11Code>00409-1005-20</NDC11Code>
    <ProductNDC>0409-1005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230227</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018916</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>[USP'U]/100mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.</IndicationAndUsage>
    <Description>Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium chloride, 0.9 g; citric acid, monohydrate, 40 mg and dibasic sodium phosphate, heptahydrate, 434 mg added as buffers. Each liter contains the following electrolytes: Sodium 186.4 mEq; phosphate (as HPO4=) 32.4 mEq, citrate 5.7 mEq and chloride 154 mEq. Osmolar concentration, 378 mOsmol/liter (calc.); pH 7.0 (5.0 – 7.5). Heparin Sodium, USP is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) &gt; (1) &gt; (4) &gt; (3) &gt; (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Dibasic Sodium Phosphate, USP (heptahydrate), is chemically designated (Na2HPO4 ∙ 7H2O), colorless or white granular salt freely soluble in water. Citric Acid, USP, hydrous (monohydrate) is chemically designated C6H8O7 ∙ H2O, colorless, translucent crystals or white crystalline powder very soluble in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from either polyvinylchloride or polyolefin plastic. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
  </NDC>
  <NDC>
    <NDCCode>11673-186-40</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (11673-186-40) </PackageDescription>
    <NDC11Code>11673-0186-40</NDC11Code>
    <ProductNDC>11673-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Nighttime Sleep Aid</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200326</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M010</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/30mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16477-186-01</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (16477-186-01)</PackageDescription>
    <NDC11Code>16477-0186-01</NDC11Code>
    <ProductNDC>16477-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Donatussin</ProprietaryName>
    <NonProprietaryName>Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140219</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Laser Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4; 20; 10</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-29</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>21695-186-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (21695-186-05)</PackageDescription>
    <NDC11Code>21695-0186-05</NDC11Code>
    <ProductNDC>21695-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfacetamide Sodium And Prednisolone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium And Prednisolone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19951229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074449</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>100; 2.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.</IndicationAndUsage>
    <Description>Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is a sterile topical ophthalmic solution combining an antibacterial and a corticosteroid. Each mL Contains: Actives: sulfacetamide sodium (as the monohydrate) 100 mg, prednisolone sodium phosphate 2.5 mg (equivalent to prednisolone phosphate 2.3 mg). Preservative: thimerosal 0.1 mg. Inactives: edetate disodium, poloxamer 407, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection. pH range is 6.5 to 7.5. The chemical name for sulfacetamide sodium, is N-sulfanilylacetamide monosodium salt monohydrate. The chemical name for prednisolone sodium phosphate is 11β,17,21-trihydroxypregna-1,4-diene-3,20-dione,21-(disodium phosphate). They have the following chemical structures.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-186-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-186-01) </PackageDescription>
    <NDC11Code>31722-0186-01</NDC11Code>
    <ProductNDC>31722-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
    <NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210929</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214959</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).</IndicationAndUsage>
    <Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red. The 5 mg capsule shell contain Titanium dioxide, FD &amp; C Blue 1, FD &amp; C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD &amp; C Blue 1, FD &amp; C Red 40, gelatin, sodium lauryl sulfate and D&amp;C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD &amp; C Blue 1, D &amp; C Red 28, gelatin and sodium lauryl sulfate. The 20 mg capsule shell contain Titanium dioxide, FD &amp; C Red 3, FD &amp; C Yellow 6, FD &amp; C Blue 1, gelatin, sodium lauryl sulfate and FD &amp; C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD &amp; C Red 40, FD &amp; C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD &amp; C Yellow 6, D &amp; C Yellow 10, sodium lauryl sulfate and gelatin. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>36800-186-37</NDCCode>
    <PackageDescription>156 g in 1 CAN (36800-186-37) </PackageDescription>
    <NDC11Code>36800-0186-37</NDC11Code>
    <ProductNDC>36800-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Topcare Everyday Sport Continuous Broad Spectrum Spf 30</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octocrylene,</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181220</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>20; 70; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>36800-186-62</NDCCode>
    <PackageDescription>3 CAN in 1 PACKAGE (36800-186-62)  / 156 g in 1 CAN (36800-186-37) </PackageDescription>
    <NDC11Code>36800-0186-62</NDC11Code>
    <ProductNDC>36800-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Topcare Everyday Sport Continuous Broad Spectrum Spf 30</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octocrylene,</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181220</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>20; 70; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>36800-186-63</NDCCode>
    <PackageDescription>2 CAN in 1 PACKAGE (36800-186-63)  / 156 g in 1 CAN (36800-186-37) </PackageDescription>
    <NDC11Code>36800-0186-63</NDC11Code>
    <ProductNDC>36800-186</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Topcare Everyday Sport Continuous Broad Spectrum Spf 30</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octocrylene,</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181220</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>20; 70; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>49348-186-20</NDCCode><ProprietaryName>Sunmark Saline Single</ProprietaryName><NonProprietaryName>Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form</NonProprietaryName></NDC><NDC><NDCCode>49348-186-14</NDCCode><ProprietaryName>Sunmark Saline Single</ProprietaryName><NonProprietaryName>Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form</NonProprietaryName></NDC><NDC><NDCCode>49348-097-47</NDCCode><ProprietaryName>Ibuprofen And Pseudoephedrine Hydrochloride</ProprietaryName><NonProprietaryName>Ibuprofen And Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49348-185-20</NDCCode><ProprietaryName>Sunmark Mineral Oil</ProprietaryName><NonProprietaryName>Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>49348-527-20</NDCCode><ProprietaryName>Sunmark Enema</ProprietaryName><NonProprietaryName>Saline</NonProprietaryName></NDC><NDC><NDCCode>49348-568-47</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>49348-864-20</NDCCode><ProprietaryName>Sunmark</ProprietaryName><NonProprietaryName>Saline Laxative</NonProprietaryName></NDC><NDC><NDCCode>49348-880-20</NDCCode><ProprietaryName>Sunmark Mineral Oil</ProprietaryName><NonProprietaryName>Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>49348-905-47</NDCCode><ProprietaryName>Sunmark Mucus Er</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>25021-186-20</NDCCode><ProprietaryName>Ampicillin And Sulbactam</ProprietaryName><NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName></NDC><NDC><NDCCode>42023-186-20</NDCCode><ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName><NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42851-186-60</NDCCode><ProprietaryName>Zo Skin Health Skin Normalizing System With Rozatrol Booster Serum</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>54111-186-20</NDCCode><ProprietaryName>Tinted Face Cream</ProprietaryName><NonProprietaryName>Octocrylene, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>55289-186-20</NDCCode><ProprietaryName>Nitrofurantoin (macrocrystals)</ProprietaryName><NonProprietaryName>Nitrofurantoin (macrocrystals)</NonProprietaryName></NDC><NDC><NDCCode>58411-186-20</NDCCode><ProprietaryName>Shiseido The Makeup Foundation</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>63323-186-20</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>64220-186-07</NDCCode><NonProprietaryName>Gefitinib</NonProprietaryName></NDC><NDC><NDCCode>71052-186-20</NDCCode><NonProprietaryName>Tylosin Tartrate</NonProprietaryName></NDC><NDC><NDCCode>71205-186-20</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71288-186-20</NDCCode><ProprietaryName>Idarubicin Hydrochloride</ProprietaryName><NonProprietaryName>Idarubicin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>79794-186-04</NDCCode><ProprietaryName>Antibacterial Hand Wipes (angel)</ProprietaryName><NonProprietaryName>Antibacterial Hand Wipes</NonProprietaryName></NDC><NDC><NDCCode>79903-186-20</NDCCode><ProprietaryName>Ibuprofen Pm</ProprietaryName><NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>0409-1005-20</NDCCode><ProprietaryName>Heparin Sodium</ProprietaryName><NonProprietaryName>Heparin Sodium</NonProprietaryName></NDC><NDC><NDCCode>11673-186-40</NDCCode><ProprietaryName>Up And Up Nighttime Sleep Aid</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16477-186-01</NDCCode><ProprietaryName>Donatussin</ProprietaryName><NonProprietaryName>Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>21695-186-05</NDCCode><ProprietaryName>Sulfacetamide Sodium And Prednisolone Sodium Phosphate</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium And Prednisolone Sodium Phosphate</NonProprietaryName></NDC><NDC><NDCCode>31722-186-01</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>36800-186-37</NDCCode><ProprietaryName>Topcare Everyday Sport Continuous Broad Spectrum Spf 30</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octocrylene,</NonProprietaryName></NDC><NDC><NDCCode>36800-186-62</NDCCode><ProprietaryName>Topcare Everyday Sport Continuous Broad Spectrum Spf 30</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octocrylene,</NonProprietaryName></NDC><NDC><NDCCode>36800-186-63</NDCCode><ProprietaryName>Topcare Everyday Sport Continuous Broad Spectrum Spf 30</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octocrylene,</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
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  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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