RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "42571-289-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-289-38) ",
      "NDC11Code": "42571-0289-38",
      "ProductNDC": "42571-289",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tofacitinib Citrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230612",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "TOFACITINIB CITRATE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-06-13",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "12-JUN-23"
    },
    {
      "NDCCode": "46122-014-38",
      "PackageDescription": "289 g in 1 BOTTLE (46122-014-38) ",
      "NDC11Code": "46122-0014-38",
      "ProductNDC": "46122-014",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Neighbor Pharmacy Clearlax",
      "NonProprietaryName": "Polyethylene Glycol 3350",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091019",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090685",
      "LabelerName": "Amerisource Bergen",
      "SubstanceName": "POLYETHYLENE GLYCOL 3350",
      "StrengthNumber": "17",
      "StrengthUnit": "g/17g",
      "Status": "Deprecated",
      "LastUpdate": "2020-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130815",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65628-201-10",
      "PackageDescription": "1 KIT in 1 BOX (65628-201-10)  *  289 mL in 1 BOTTLE, PLASTIC *  15.38 g in 1 BOTTLE, PLASTIC",
      "NDC11Code": "65628-0201-10",
      "ProductNDC": "65628-201",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Vancomycin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140317",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "CutisPharma, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "42571-154-38",
      "PackageDescription": "10 kg in 1 BAG (42571-154-38)",
      "NDC11Code": "42571-0154-38",
      "ProductNDC": "42571-154",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140411",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "42571-279-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-279-38) ",
      "NDC11Code": "42571-0279-38",
      "ProductNDC": "42571-279",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130925",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-05",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "25-SEP-13"
    },
    {
      "NDCCode": "42571-280-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-280-38) ",
      "NDC11Code": "42571-0280-38",
      "ProductNDC": "42571-280",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Rasagiline Mesylate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130910",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "RASAGILINE MESYLATE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-05",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "10-SEP-13"
    },
    {
      "NDCCode": "42571-281-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-281-38) ",
      "NDC11Code": "42571-0281-38",
      "ProductNDC": "42571-281",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Bromfenac Sodium Sesquihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20181030",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "BROMFENAC SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-12-10",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "30-OCT-18"
    },
    {
      "NDCCode": "42571-283-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-283-38) ",
      "NDC11Code": "42571-0283-38",
      "ProductNDC": "42571-283",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sodium Nitroprusside",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210419",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "SODIUM NITROPRUSSIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-04-21",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19-APR-21"
    },
    {
      "NDCCode": "42571-285-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-285-38) ",
      "NDC11Code": "42571-0285-38",
      "ProductNDC": "42571-285",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Isoproterenol Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150928",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-05",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "28-SEP-15"
    },
    {
      "NDCCode": "42571-306-38",
      "PackageDescription": "3 kg in 1 DRUM (42571-306-38)",
      "NDC11Code": "42571-0306-38",
      "ProductNDC": "42571-306",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Besifloxacin Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170809",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "BESIFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "kg/3kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "42571-329-38",
      "PackageDescription": "20 kg in 1 DRUM (42571-329-38)",
      "NDC11Code": "42571-0329-38",
      "ProductNDC": "42571-329",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Pirfenidone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180416",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "PIRFENIDONE",
      "StrengthNumber": "20",
      "StrengthUnit": "kg/20kg",
      "Status": "Unfinished",
      "LastUpdate": "2020-07-07",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "42571-331-38",
      "PackageDescription": "25 VIAL in 1 CARTON (42571-331-38)  / 5 mL in 1 VIAL",
      "NDC11Code": "42571-0331-38",
      "ProductNDC": "42571-331",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20191004",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211954",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260803",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4) .",
      "Description": "Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [ see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "42571-338-38",
      "PackageDescription": "50 kg in 1 DRUM (42571-338-38)",
      "NDC11Code": "42571-0338-38",
      "ProductNDC": "42571-338",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dalfampridine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190702",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DALFAMPRIDINE",
      "StrengthNumber": "50",
      "StrengthUnit": "kg/50kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "42571-353-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-353-38) ",
      "NDC11Code": "42571-0353-38",
      "ProductNDC": "42571-353",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nepafenac",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190620",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "NEPAFENAC",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-02-27",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20-JUN-19"
    },
    {
      "NDCCode": "42571-413-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-413-38) ",
      "NDC11Code": "42571-0413-38",
      "ProductNDC": "42571-413",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Anagrelide Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220310",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "ANAGRELIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-03-12",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "10-MAR-22"
    },
    {
      "NDCCode": "42571-430-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-430-38) ",
      "NDC11Code": "42571-0430-38",
      "ProductNDC": "42571-430",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-23",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-JAN-26"
    },
    {
      "NDCCode": "42571-445-38",
      "PackageDescription": "10 kg in 1 DRUM (42571-445-38) ",
      "NDC11Code": "42571-0445-38",
      "ProductNDC": "42571-445",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cromolyn Sodium",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20250612",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CROMOLYN SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-06-14",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "12-JUN-25"
    },
    {
      "NDCCode": "11704-101-01",
      "PackageDescription": ".7 mL in 1 SYRINGE, PLASTIC (11704-101-01) ",
      "NDC11Code": "11704-0101-01",
      "ProductNDC": "11704-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropen Auto-injector",
      "NonProprietaryName": "Atropine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19730515",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017106",
      "LabelerName": "Meridian Medical Technologies LLC",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/.7mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19730515",
      "SamplePackage": "N",
      "IndicationAndUsage": "ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.",
      "Description": "Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:."
    },
    {
      "NDCCode": "11704-104-01",
      "PackageDescription": ".7 mL in 1 SYRINGE, PLASTIC (11704-104-01) ",
      "NDC11Code": "11704-0104-01",
      "ProductNDC": "11704-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropen Auto-injector",
      "NonProprietaryName": "Atropine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20030619",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017106",
      "LabelerName": "Meridian Medical Technologies LLC",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/.7mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20030619",
      "SamplePackage": "N",
      "IndicationAndUsage": "ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.",
      "Description": "Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:."
    },
    {
      "NDCCode": "11704-105-01",
      "PackageDescription": ".7 mL in 1 SYRINGE, PLASTIC (11704-105-01) ",
      "NDC11Code": "11704-0105-01",
      "ProductNDC": "11704-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropen Auto-injector",
      "NonProprietaryName": "Atropine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20030619",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017106",
      "LabelerName": "Meridian Medical Technologies LLC",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/.7mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20030619",
      "SamplePackage": "N",
      "IndicationAndUsage": "ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.",
      "Description": "Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:."
    },
    {
      "NDCCode": "11704-106-01",
      "PackageDescription": ".7 mL in 1 SYRINGE, PLASTIC (11704-106-01) ",
      "NDC11Code": "11704-0106-01",
      "ProductNDC": "11704-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropen Auto-injector",
      "NonProprietaryName": "Atropine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20030619",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017106",
      "LabelerName": "Meridian Medical Technologies LLC",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/.7mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20030619",
      "SamplePackage": "N",
      "IndicationAndUsage": "ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.",
      "Description": "Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:."
    },
    {
      "NDCCode": "11704-107-01",
      "PackageDescription": ".3 mL in 1 SYRINGE, GLASS (11704-107-01) ",
      "NDC11Code": "11704-0107-01",
      "ProductNDC": "11704-107",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropen Auto-injector",
      "NonProprietaryName": "Atropine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20040917",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017106",
      "LabelerName": "Meridian Medical Technologies LLC",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20040917",
      "SamplePackage": "N",
      "IndicationAndUsage": "ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.",
      "Description": "Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:."
    },
    {
      "NDCCode": "55111-289-60",
      "PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60) ",
      "NDC11Code": "55111-0289-60",
      "ProductNDC": "55111-289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen And Esomeprazole Magnesium",
      "NonProprietaryName": "Naproxen And Esomeprazole Magnesium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204206",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "NAPROXEN; ESOMEPRAZOLE MAGNESIUM",
      "StrengthNumber": "375; 20",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-04-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:.  osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.  juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use:.  Do not substitute naproxen and esomeprazole magnesium delayed-release tablet with the single-ingredient products of naproxen and esomeprazole magnesium.  Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products.  Controlled studies do not extend beyond 6 months [see Use in Specific Populations (8.4), Clinical Studies (14)].",
      "Description": "The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and  practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2Mg with molecular weight of 713.1. The structural formula is. The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C."
    },
    {
      "NDCCode": "71053-590-01",
      "PackageDescription": ".7 mL in 1 SYRINGE (71053-590-01) ",
      "NDC11Code": "71053-0590-01",
      "ProductNDC": "71053-590",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "N/a",
      "NonProprietaryName": "Atropine Sulfate Injection Usp, 0.5 Mg/0.7 Ml",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20180309",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Rafa Laboratories, Ltd.",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/.7mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180309",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).",
      "Description": "The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer). The pH range is 4.1 - 4.5. Atropine, a cholinergic muscarinic antagonist, occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine; its activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-tropan-3–ol (±)-tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is:."
    },
    {
      "NDCCode": "71053-591-01",
      "PackageDescription": ".7 mL in 1 SYRINGE (71053-591-01) ",
      "NDC11Code": "71053-0591-01",
      "ProductNDC": "71053-591",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "N/a",
      "NonProprietaryName": "Atropine Sulfate Injection Usp, 1 Mg/0.7 Ml",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20180309",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Rafa Laboratories, Ltd.",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/.7mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180309",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).",
      "Description": "The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer). The pH range is 4.1 - 4.5. Atropine, a cholinergic muscarinic antagonist, occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine; its activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-tropan-3–ol (±)-tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is:."
    },
    {
      "NDCCode": "71053-592-01",
      "PackageDescription": "480 CARTON in 1 BOX (71053-592-01)  / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE",
      "NDC11Code": "71053-0592-01",
      "ProductNDC": "71053-592",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "N/a",
      "NonProprietaryName": "Atropine Injection, 2 Mg",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20180709",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212319",
      "LabelerName": "Rafa Laboratories, Ltd.",
      "SubstanceName": "ATROPINE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/.7mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180709",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).",
      "Description": "The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer). The pH range is 4.1 - 4.5. Atropine, a cholinergic muscarinic antagonist, occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine; its activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-tropan-3–ol (±)-tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is:."
    },
    {
      "NDCCode": "42571-142-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (42571-142-05) ",
      "NDC11Code": "42571-0142-05",
      "ProductNDC": "42571-142",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204776",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib is indicated.",
      "Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
    },
    {
      "NDCCode": "42571-142-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (42571-142-30) ",
      "NDC11Code": "42571-0142-30",
      "ProductNDC": "42571-142",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204776",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib is indicated.",
      "Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
    },
    {
      "NDCCode": "42571-142-33",
      "PackageDescription": "7 BLISTER PACK in 1 CARTON (42571-142-33)  / 10 CAPSULE in 1 BLISTER PACK (42571-142-32) ",
      "NDC11Code": "42571-0142-33",
      "ProductNDC": "42571-142",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204776",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib is indicated.",
      "Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
    },
    {
      "NDCCode": "42571-142-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (42571-142-60) ",
      "NDC11Code": "42571-0142-60",
      "ProductNDC": "42571-142",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204776",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib is indicated.",
      "Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"42571-289-38","NonProprietaryName":"Tofacitinib Citrate"},{"NDCCode":"46122-014-38","ProprietaryName":"Good Neighbor Pharmacy Clearlax","NonProprietaryName":"Polyethylene Glycol 3350"},{"NDCCode":"65628-201-10","NonProprietaryName":"Vancomycin"},{"NDCCode":"42571-154-38","NonProprietaryName":"Escitalopram Oxalate"},{"NDCCode":"42571-279-38","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"42571-280-38","NonProprietaryName":"Rasagiline Mesylate"},{"NDCCode":"42571-281-38","NonProprietaryName":"Bromfenac Sodium Sesquihydrate"},{"NDCCode":"42571-283-38","NonProprietaryName":"Sodium Nitroprusside"},{"NDCCode":"42571-285-38","NonProprietaryName":"Isoproterenol Hydrochloride"},{"NDCCode":"42571-306-38","NonProprietaryName":"Besifloxacin Hydrochloride"},{"NDCCode":"42571-329-38","NonProprietaryName":"Pirfenidone"},{"NDCCode":"42571-331-38","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"42571-338-38","NonProprietaryName":"Dalfampridine"},{"NDCCode":"42571-353-38","NonProprietaryName":"Nepafenac"},{"NDCCode":"42571-413-38","NonProprietaryName":"Anagrelide Hydrochloride"},{"NDCCode":"42571-430-38","NonProprietaryName":"Glimepiride"},{"NDCCode":"42571-445-38","NonProprietaryName":"Cromolyn Sodium"},{"NDCCode":"11704-101-01","ProprietaryName":"Atropen Auto-injector","NonProprietaryName":"Atropine"},{"NDCCode":"11704-104-01","ProprietaryName":"Atropen Auto-injector","NonProprietaryName":"Atropine"},{"NDCCode":"11704-105-01","ProprietaryName":"Atropen Auto-injector","NonProprietaryName":"Atropine"},{"NDCCode":"11704-106-01","ProprietaryName":"Atropen Auto-injector","NonProprietaryName":"Atropine"},{"NDCCode":"11704-107-01","ProprietaryName":"Atropen Auto-injector","NonProprietaryName":"Atropine"},{"NDCCode":"55111-289-60","ProprietaryName":"Naproxen And Esomeprazole Magnesium","NonProprietaryName":"Naproxen And Esomeprazole Magnesium"},{"NDCCode":"71053-590-01","ProprietaryName":"N/a","NonProprietaryName":"Atropine Sulfate Injection Usp, 0.5 Mg/0.7 Ml"},{"NDCCode":"71053-591-01","ProprietaryName":"N/a","NonProprietaryName":"Atropine Sulfate Injection Usp, 1 Mg/0.7 Ml"},{"NDCCode":"71053-592-01","ProprietaryName":"N/a","NonProprietaryName":"Atropine Injection, 2 Mg"},{"NDCCode":"42571-142-05","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"},{"NDCCode":"42571-142-30","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"},{"NDCCode":"42571-142-33","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"},{"NDCCode":"42571-142-60","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>42571-289-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-289-38) </PackageDescription>
    <NDC11Code>42571-0289-38</NDC11Code>
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    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-06-13</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-JUN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>46122-014-38</NDCCode>
    <PackageDescription>289 g in 1 BOTTLE (46122-014-38) </PackageDescription>
    <NDC11Code>46122-0014-38</NDC11Code>
    <ProductNDC>46122-014</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Good Neighbor Pharmacy Clearlax</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091019</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090685</ApplicationNumber>
    <LabelerName>Amerisource Bergen</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/17g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>65628-201-10</NDCCode>
    <PackageDescription>1 KIT in 1 BOX (65628-201-10)  *  289 mL in 1 BOTTLE, PLASTIC *  15.38 g in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>65628-0201-10</NDC11Code>
    <ProductNDC>65628-201</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Vancomycin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20140317</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>CutisPharma, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42571-154-38</NDCCode>
    <PackageDescription>10 kg in 1 BAG (42571-154-38)</PackageDescription>
    <NDC11Code>42571-0154-38</NDC11Code>
    <ProductNDC>42571-154</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20140411</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42571-279-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-279-38) </PackageDescription>
    <NDC11Code>42571-0279-38</NDC11Code>
    <ProductNDC>42571-279</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130925</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-05</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>25-SEP-13</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>42571-280-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-280-38) </PackageDescription>
    <NDC11Code>42571-0280-38</NDC11Code>
    <ProductNDC>42571-280</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Rasagiline Mesylate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130910</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>RASAGILINE MESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-05</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>10-SEP-13</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>42571-281-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-281-38) </PackageDescription>
    <NDC11Code>42571-0281-38</NDC11Code>
    <ProductNDC>42571-281</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Bromfenac Sodium Sesquihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20181030</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>BROMFENAC SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-12-10</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-OCT-18</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42571-283-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-283-38) </PackageDescription>
    <NDC11Code>42571-0283-38</NDC11Code>
    <ProductNDC>42571-283</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20210419</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-04-21</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19-APR-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42571-285-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-285-38) </PackageDescription>
    <NDC11Code>42571-0285-38</NDC11Code>
    <ProductNDC>42571-285</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150928</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>ISOPROTERENOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-05</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>28-SEP-15</StartMarketingDatePackage>
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  <NDC>
    <NDCCode>42571-306-38</NDCCode>
    <PackageDescription>3 kg in 1 DRUM (42571-306-38)</PackageDescription>
    <NDC11Code>42571-0306-38</NDC11Code>
    <ProductNDC>42571-306</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Besifloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170809</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>BESIFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>kg/3kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42571-329-38</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (42571-329-38)</PackageDescription>
    <NDC11Code>42571-0329-38</NDC11Code>
    <ProductNDC>42571-329</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Pirfenidone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180416</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>PIRFENIDONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>kg/20kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-07-07</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42571-331-38</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (42571-331-38)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>42571-0331-38</NDC11Code>
    <ProductNDC>42571-331</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20191004</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211954</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260803</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) . Levetiracetam injection is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) . Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4) .</IndicationAndUsage>
    <Description>Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [ see Dosage and Administration (2.6)].</Description>
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  <NDC>
    <NDCCode>42571-338-38</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (42571-338-38)</PackageDescription>
    <NDC11Code>42571-0338-38</NDC11Code>
    <ProductNDC>42571-338</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dalfampridine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190702</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>DALFAMPRIDINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>kg/50kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42571-353-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-353-38) </PackageDescription>
    <NDC11Code>42571-0353-38</NDC11Code>
    <ProductNDC>42571-353</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nepafenac</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190620</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>NEPAFENAC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-02-27</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-JUN-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42571-413-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-413-38) </PackageDescription>
    <NDC11Code>42571-0413-38</NDC11Code>
    <ProductNDC>42571-413</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Anagrelide Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220310</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>ANAGRELIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-03-12</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>10-MAR-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42571-430-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-430-38) </PackageDescription>
    <NDC11Code>42571-0430-38</NDC11Code>
    <ProductNDC>42571-430</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Glimepiride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>GLIMEPIRIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42571-445-38</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (42571-445-38) </PackageDescription>
    <NDC11Code>42571-0445-38</NDC11Code>
    <ProductNDC>42571-445</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cromolyn Sodium</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20250612</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CROMOLYN SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-06-14</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-JUN-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11704-101-01</NDCCode>
    <PackageDescription>.7 mL in 1 SYRINGE, PLASTIC (11704-101-01) </PackageDescription>
    <NDC11Code>11704-0101-01</NDC11Code>
    <ProductNDC>11704-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropen Auto-injector</ProprietaryName>
    <NonProprietaryName>Atropine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>19730515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017106</ApplicationNumber>
    <LabelerName>Meridian Medical Technologies LLC</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/.7mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19730515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.</IndicationAndUsage>
    <Description>Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>11704-104-01</NDCCode>
    <PackageDescription>.7 mL in 1 SYRINGE, PLASTIC (11704-104-01) </PackageDescription>
    <NDC11Code>11704-0104-01</NDC11Code>
    <ProductNDC>11704-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropen Auto-injector</ProprietaryName>
    <NonProprietaryName>Atropine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20030619</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017106</ApplicationNumber>
    <LabelerName>Meridian Medical Technologies LLC</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/.7mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.</IndicationAndUsage>
    <Description>Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>11704-105-01</NDCCode>
    <PackageDescription>.7 mL in 1 SYRINGE, PLASTIC (11704-105-01) </PackageDescription>
    <NDC11Code>11704-0105-01</NDC11Code>
    <ProductNDC>11704-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropen Auto-injector</ProprietaryName>
    <NonProprietaryName>Atropine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20030619</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017106</ApplicationNumber>
    <LabelerName>Meridian Medical Technologies LLC</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/.7mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.</IndicationAndUsage>
    <Description>Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>11704-106-01</NDCCode>
    <PackageDescription>.7 mL in 1 SYRINGE, PLASTIC (11704-106-01) </PackageDescription>
    <NDC11Code>11704-0106-01</NDC11Code>
    <ProductNDC>11704-106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropen Auto-injector</ProprietaryName>
    <NonProprietaryName>Atropine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20030619</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017106</ApplicationNumber>
    <LabelerName>Meridian Medical Technologies LLC</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/.7mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030619</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.</IndicationAndUsage>
    <Description>Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>11704-107-01</NDCCode>
    <PackageDescription>.3 mL in 1 SYRINGE, GLASS (11704-107-01) </PackageDescription>
    <NDC11Code>11704-0107-01</NDC11Code>
    <ProductNDC>11704-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropen Auto-injector</ProprietaryName>
    <NonProprietaryName>Atropine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20040917</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017106</ApplicationNumber>
    <LabelerName>Meridian Medical Technologies LLC</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients.</IndicationAndUsage>
    <Description>Each prefilled ATROPEN single-dose autoinjector provides an intramuscular dose of atropine, a cholinergic muscarinic antagonist in a self-contained unit, designed for self- or caregiver-administration. When activated, the ATROPEN 0.25 mg autoinjector delivers 0.21 mg atropine base (equivalent to 0.25 mg atropine sulfate) in 0.3 mL of sterile pyrogen-free solution containing citrate buffer, sodium chloride, and Water for Injection. The pH range is 4.0 to 5.0. When activated, the ATROPEN 0.5 mg autoinjector delivers 0.42 mg atropine base (equivalent to 0.5 mg atropine sulfate), the ATROPEN 1 mg autoinjector delivers 0.84 mg atropine base (equivalent to 1 mg atropine sulfate), and the ATROPEN 2 mg autoinjector delivers 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). Each 0.5 mg, 1 mg, and 2 mg ATROPEN autoinjector delivers atropine in 0.7 mL of sterile pyrogen-free solution containing 12.5 mg glycerin, 2.8 mg phenol, citrate buffer, and Water for Injection. The pH range is 4.0 to 5.0. Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-Tropan-3α-ol (±) tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-289-60</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60) </PackageDescription>
    <NDC11Code>55111-0289-60</NDC11Code>
    <ProductNDC>55111-289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen And Esomeprazole Magnesium</ProprietaryName>
    <NonProprietaryName>Naproxen And Esomeprazole Magnesium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204206</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>NAPROXEN; ESOMEPRAZOLE MAGNESIUM</SubstanceName>
    <StrengthNumber>375; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:.  osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.  juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use:.  Do not substitute naproxen and esomeprazole magnesium delayed-release tablet with the single-ingredient products of naproxen and esomeprazole magnesium.  Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products.  Controlled studies do not extend beyond 6 months [see Use in Specific Populations (8.4), Clinical Studies (14)].</IndicationAndUsage>
    <Description>The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and  practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2Mg with molecular weight of 713.1. The structural formula is. The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>71053-590-01</NDCCode>
    <PackageDescription>.7 mL in 1 SYRINGE (71053-590-01) </PackageDescription>
    <NDC11Code>71053-0590-01</NDC11Code>
    <ProductNDC>71053-590</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>N/a</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate Injection Usp, 0.5 Mg/0.7 Ml</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20180309</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Rafa Laboratories, Ltd.</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/.7mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).</IndicationAndUsage>
    <Description>The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer). The pH range is 4.1 - 4.5. Atropine, a cholinergic muscarinic antagonist, occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine; its activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-tropan-3–ol (±)-tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>71053-591-01</NDCCode>
    <PackageDescription>.7 mL in 1 SYRINGE (71053-591-01) </PackageDescription>
    <NDC11Code>71053-0591-01</NDC11Code>
    <ProductNDC>71053-591</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>N/a</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate Injection Usp, 1 Mg/0.7 Ml</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20180309</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Rafa Laboratories, Ltd.</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/.7mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180309</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).</IndicationAndUsage>
    <Description>The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer). The pH range is 4.1 - 4.5. Atropine, a cholinergic muscarinic antagonist, occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine; its activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-tropan-3–ol (±)-tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>71053-592-01</NDCCode>
    <PackageDescription>480 CARTON in 1 BOX (71053-592-01)  / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>71053-0592-01</NDC11Code>
    <ProductNDC>71053-592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>N/a</ProprietaryName>
    <NonProprietaryName>Atropine Injection, 2 Mg</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20180709</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212319</ApplicationNumber>
    <LabelerName>Rafa Laboratories, Ltd.</LabelerName>
    <SubstanceName>ATROPINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/.7mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180709</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).</IndicationAndUsage>
    <Description>The Atropine prefilled autoinjector is a single dose, self-contained unit designed for self or caregiver administration. Each 2 mg Atropine autoinjector delivers 1.67 mg atropine (equivalent to 2 mg atropine sulfate) in 0.7 mL of sterile pyrogen-free solution for intramuscular injection. Each 2 mg autoinjector also contains the following inactive ingredients: 3.27 mg citric acid monohydrate (buffer), 12.47 mg glycerin, 2.8 mg phenol, and 3.05 mg sodium citrate dihydrate (buffer). The pH range is 4.1 - 4.5. Atropine, a cholinergic muscarinic antagonist, occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is highly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine; its activity is due almost entirely to the levo isomer of the drug. Chemically, atropine is designated as 1αH,5αH-tropan-3–ol (±)-tropate (ester). Its empirical formula is C17H23NO3 and its structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-142-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (42571-142-05) </PackageDescription>
    <NDC11Code>42571-0142-05</NDC11Code>
    <ProductNDC>42571-142</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204776</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
    <Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-142-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (42571-142-30) </PackageDescription>
    <NDC11Code>42571-0142-30</NDC11Code>
    <ProductNDC>42571-142</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204776</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
    <Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-142-33</NDCCode>
    <PackageDescription>7 BLISTER PACK in 1 CARTON (42571-142-33)  / 10 CAPSULE in 1 BLISTER PACK (42571-142-32) </PackageDescription>
    <NDC11Code>42571-0142-33</NDC11Code>
    <ProductNDC>42571-142</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204776</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
    <Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-142-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (42571-142-60) </PackageDescription>
    <NDC11Code>42571-0142-60</NDC11Code>
    <ProductNDC>42571-142</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204776</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
    <Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>42571-289-38</NDCCode><NonProprietaryName>Tofacitinib Citrate</NonProprietaryName></NDC><NDC><NDCCode>46122-014-38</NDCCode><ProprietaryName>Good Neighbor Pharmacy Clearlax</ProprietaryName><NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName></NDC><NDC><NDCCode>65628-201-10</NDCCode><NonProprietaryName>Vancomycin</NonProprietaryName></NDC><NDC><NDCCode>42571-154-38</NDCCode><NonProprietaryName>Escitalopram Oxalate</NonProprietaryName></NDC><NDC><NDCCode>42571-279-38</NDCCode><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>42571-280-38</NDCCode><NonProprietaryName>Rasagiline Mesylate</NonProprietaryName></NDC><NDC><NDCCode>42571-281-38</NDCCode><NonProprietaryName>Bromfenac Sodium Sesquihydrate</NonProprietaryName></NDC><NDC><NDCCode>42571-283-38</NDCCode><NonProprietaryName>Sodium Nitroprusside</NonProprietaryName></NDC><NDC><NDCCode>42571-285-38</NDCCode><NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-306-38</NDCCode><NonProprietaryName>Besifloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-329-38</NDCCode><NonProprietaryName>Pirfenidone</NonProprietaryName></NDC><NDC><NDCCode>42571-331-38</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>42571-338-38</NDCCode><NonProprietaryName>Dalfampridine</NonProprietaryName></NDC><NDC><NDCCode>42571-353-38</NDCCode><NonProprietaryName>Nepafenac</NonProprietaryName></NDC><NDC><NDCCode>42571-413-38</NDCCode><NonProprietaryName>Anagrelide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-430-38</NDCCode><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>42571-445-38</NDCCode><NonProprietaryName>Cromolyn Sodium</NonProprietaryName></NDC><NDC><NDCCode>11704-101-01</NDCCode><ProprietaryName>Atropen Auto-injector</ProprietaryName><NonProprietaryName>Atropine</NonProprietaryName></NDC><NDC><NDCCode>11704-104-01</NDCCode><ProprietaryName>Atropen Auto-injector</ProprietaryName><NonProprietaryName>Atropine</NonProprietaryName></NDC><NDC><NDCCode>11704-105-01</NDCCode><ProprietaryName>Atropen Auto-injector</ProprietaryName><NonProprietaryName>Atropine</NonProprietaryName></NDC><NDC><NDCCode>11704-106-01</NDCCode><ProprietaryName>Atropen Auto-injector</ProprietaryName><NonProprietaryName>Atropine</NonProprietaryName></NDC><NDC><NDCCode>11704-107-01</NDCCode><ProprietaryName>Atropen Auto-injector</ProprietaryName><NonProprietaryName>Atropine</NonProprietaryName></NDC><NDC><NDCCode>55111-289-60</NDCCode><ProprietaryName>Naproxen And Esomeprazole Magnesium</ProprietaryName><NonProprietaryName>Naproxen And Esomeprazole Magnesium</NonProprietaryName></NDC><NDC><NDCCode>71053-590-01</NDCCode><ProprietaryName>N/a</ProprietaryName><NonProprietaryName>Atropine Sulfate Injection Usp, 0.5 Mg/0.7 Ml</NonProprietaryName></NDC><NDC><NDCCode>71053-591-01</NDCCode><ProprietaryName>N/a</ProprietaryName><NonProprietaryName>Atropine Sulfate Injection Usp, 1 Mg/0.7 Ml</NonProprietaryName></NDC><NDC><NDCCode>71053-592-01</NDCCode><ProprietaryName>N/a</ProprietaryName><NonProprietaryName>Atropine Injection, 2 Mg</NonProprietaryName></NDC><NDC><NDCCode>42571-142-05</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>42571-142-30</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>42571-142-33</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>42571-142-60</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</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",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
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      "AuthorizedOfficialNamePrefix": "MR.",
      "AuthorizedOfficialTelephoneNumber": "206-838-2599",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "601484763",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207W00000X",
      "Taxonomy2": "Ophthalmology",
      "LicenseNumber2": "601484763",
      "LicenseNumberStateCode2": "WA",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "222338",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "WA",
      "OtherIdentifierIssuer1": "WA STATE L & I",
      "OtherIdentifier2": "2001403",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "WA",
      "OtherIdentifier3": "G8867851",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "WA",
      "OtherIdentifierIssuer3": "MEDICARE PTAN",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1447771951",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "JEFF BINSTOCK, DVM, OD, FAAO, PLLC",
      "OtherOrgName": "REDMOND EYE CLINIC",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "(425) 885-3574",
      "EnumerationDate": "07/05/2017",
      "LastUpdateDate": "12/27/2017",
      "AuthorizedOfficialLastName": "BINSTOCK",
      "AuthorizedOfficialFirstName": "JEFF",
      "AuthorizedOfficialTitle": "MEMBER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "DVM, OD, FAAO",
      "AuthorizedOfficialTelephoneNumber": "818-620-7641",
      "TaxonomyCode1": "152WC0802X",
      "Taxonomy1": "Corneal and Contact Management",
      "LicenseNumber1": "60553429",
      "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": "1689189151",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "PERSONALEYES, LLC",
      "OtherOrgName": "WILLOW CREEK EYE CARE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "1000 SW INDIAN AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3039",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-2488",
      "MailingAddressFaxNumber": "541-548-5334",
      "FirstLinePracticeLocationAddress": "14740 NW CORNELL RD",
      "PracticeLocationAddressCityName": "PORTLAND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97229-5496",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "503-645-8002",
      "PracticeLocationAddressFaxNumber": "503-645-9455",
      "EnumerationDate": "12/06/2017",
      "LastUpdateDate": "12/06/2017",
      "AuthorizedOfficialLastName": "SHELDON",
      "AuthorizedOfficialFirstName": "TODD",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialCredential": "OD, MBA, FAAO",
      "AuthorizedOfficialTelephoneNumber": "541-548-2488",
      "TaxonomyCode1": "261QM2500X",
      "Taxonomy1": "Medical Specialty ",
      "LicenseNumber1": "2823ATI",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1225534910",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MAZHAR",
      "FirstName": "SAHAR",
      "MiddleName": "RANIA",
      "FirstLineMailingAddress": "1108 ROSS CLARK CIR",
      "MailingAddressCityName": "DOTHAN",
      "MailingAddressStateName": "AL",
      "MailingAddressPostalCode": "36301-3022",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "334-712-3329",
      "FirstLinePracticeLocationAddress": "1108 ROSS CLARK CIR",
      "PracticeLocationAddressCityName": "DOTHAN",
      "PracticeLocationAddressStateName": "AL",
      "PracticeLocationAddressPostalCode": "36301-3022",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "334-712-3329",
      "EnumerationDate": "04/02/2018",
      "LastUpdateDate": "04/02/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1922502889",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FADLALLA",
      "FirstName": "RANIA",
      "MiddleName": "ABDALLA DAW ELBEIT",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 BAY AVE",
      "MailingAddressCityName": "MONTCLAIR",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "07042-4837",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "973-429-6196",
      "FirstLinePracticeLocationAddress": "1 BAY AVE",
      "PracticeLocationAddressCityName": "MONTCLAIR",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "07042-4837",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "973-429-6196",
      "EnumerationDate": "03/23/2018",
      "LastUpdateDate": "03/23/2018",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "390200000X",
      "Taxonomy1": "Student in an Organized Health Care Education/Training Program",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1629068499",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "FAHOURY",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLineMailingAddress": "SUITE 201",
      "MailingAddressCityName": "TOLEDO",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "43623-3525",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "419-843-3627",
      "MailingAddressFaxNumber": "419-843-9697",
      "FirstLinePracticeLocationAddress": "4411 N HOLLAND SYLVANIA RD",
      "SecondLinePracticeLocationAddress": "SUITE 201",
      "PracticeLocationAddressCityName": "TOLEDO",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "43623-3525",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "419-843-3627",
      "PracticeLocationAddressFaxNumber": "419-843-9697",
      "EnumerationDate": "10/24/2005",
      "LastUpdateDate": "09/02/2011",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "35086663",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2621621",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH",
      "OtherIdentifier2": "P00401238",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OH",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
    },
    {
      "NPI": "1033186986",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "NICOLA",
      "FirstName": "RANIA",
      "MiddleName": "SOLIMAN",
      "NamePrefix": "DR.",
      "Credential": "DDS",
      "FirstLineMailingAddress": "110 S WOODLAND ST",
      "MailingAddressCityName": "WINTER GARDEN",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "34787-3546",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "407-905-8827",
      "MailingAddressFaxNumber": "407-645-4587",
      "FirstLinePracticeLocationAddress": "7900 FOREST CITY RD",
      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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