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How to Find 43598-330-11 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "43598-330-11",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (43598-330-11)  / 5 mL in 1 VIAL, GLASS",
      "NDC11Code": "43598-0330-11",
      "ProductNDC": "43598-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zoledronic Acid",
      "NonProprietaryName": "Zoledronic Acid",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130819",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091186",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "SubstanceName": "ZOLEDRONIC ACID",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
      "Status": "Active",
      "LastUpdate": "2024-01-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130819",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zoledronic acid injection is a bisphosphonate indicated for the treatment of: 1 Hypercalcemia of malignancy. (1.1), 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)  .",
      "Description": "Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is. Zoledronic acid is white to almost white crystalline solid. Its molecular formula is C5H10N2O7P2  H2O and its molar mass is 290.1g/mol. Zoledronic acid is sparingly soluble in 0.1N sodium hydroxide solution. The pH of a 0.7% aqueous solution of zoledronic acid is between 1.5 and 2.5. Zoledronic acid injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg zoledronic acid monohydrate, USP corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and 24 mg of sodium citrate, USP. Inactive Ingredients: mannitol, USP, as bulking agent, sodium citrate, USP, as buffering agent and water for injection as vehicle."
    },
    {
      "NDCCode": "46987-330-11",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46987-330-11)",
      "NDC11Code": "46987-0330-11",
      "ProductNDC": "46987-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kadian",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120507",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020616",
      "LabelerName": "Actavis Kadian LLC",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "49591-330-51",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (49591-330-51)  / 1.3 mL in 1 VIAL, GLASS (49591-330-11) ",
      "NDC11Code": "49591-0330-51",
      "ProductNDC": "49591-330",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Winrho Sdf",
      "NonProprietaryName": "Human Rho(d) Immune Globulin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20230801",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103649",
      "LabelerName": "Kamada Ltd.",
      "SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
      "StrengthNumber": "1500",
      "StrengthUnit": "[iU]/1.3mL",
      "Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230801",
      "SamplePackage": "N",
      "IndicationAndUsage": "WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.",
      "Description": "WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA."
    },
    {
      "NDCCode": "50268-330-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-330-15)  / 1 TABLET in 1 BLISTER PACK (50268-330-11) ",
      "NDC11Code": "50268-0330-15",
      "ProductNDC": "50268-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fludrocortisone Acetate",
      "NonProprietaryName": "Fludrocortisone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040431",
      "LabelerName": "AvPAK",
      "SubstanceName": "FLUDROCORTISONE ACETATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fludrocortisone acetate tablets USP, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.",
      "Description": "Fludrocortisone Acetate Tablets USP, 0.1 mg contain fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The chemical name for fludrocortisone acetate is 9-fluoro-11β, 17, 21-trihydroxypregn-4-ene-3, 20- dione 21-acetate; its structural formula is. Fludrocortisone acetate tablets USP, 0.1 mg are available for oral administration as scored tablets providing 0.1 mg fludrocortisone acetate per tablet. Inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, and microcrystalline cellulose NF."
    },
    {
      "NDCCode": "50419-330-11",
      "PackageDescription": "5 SYRINGE in 1 CARTON (50419-330-11)  / 7.5 mL in 1 SYRINGE (50419-330-01) ",
      "NDC11Code": "50419-0330-11",
      "ProductNDC": "50419-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambelvist",
      "NonProprietaryName": "Gadoquatrane",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260612",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA219627",
      "LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
      "SubstanceName": "GADOQUATRANE",
      "StrengthNumber": "257.9",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260612",
      "SamplePackage": "N",
      "IndicationAndUsage": "AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: : 1 the central nervous system (brain, spine, and associated tissues) , 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) .",
      "Description": "AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use. The chemical name for gadoquatrane is tetragadolinium [4,10-bis(carboxylatomethyl)-7-{3,6,12,15-tetraoxo-16-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]-9,9-bis({[({2-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]propanoyl}amino)acetyl]-amino}methyl)-4,7,11,14-tetraazaheptadecan-2-yl}-1,4,7,10-tetraazacyclododecan-1-yl]acetate, with a molecular formula of C81H128Gd4N24O32 and a molecular weight of 2,579.1 g/mol. The structural formula of gadoquatrane is. AMBELVIST is a sterile, clear, colorless to pale yellow solution. Each mL contains 257.9 mg (0.1 mmol) of gadoquatrane (containing 0.4 mmol of gadolinium) and the following inactive ingredients: 0.196 mg of calcobutrol, 3.14 mg of sodium chloride,1.21 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. The main physicochemical properties of AMBELVIST are listed in Table 2."
    },
    {
      "NDCCode": "54568-341-11",
      "PackageDescription": "30 BOX in 1 BOX (54568-341-11)  / 330 CARTRIDGE in 1 BOX / 2.4 mL in 1 CARTRIDGE",
      "NDC11Code": "54568-0341-11",
      "ProductNDC": "54568-341",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Tirzepatide",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20240206",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Eli Lilly Italia SPA",
      "SubstanceName": "TIRZEPATIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/.6mL",
      "Status": "Unfinished",
      "LastUpdate": "2026-08-24",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20-AUG-26"
    },
    {
      "NDCCode": "55570-330-11",
      "PackageDescription": "50 kg in 1 DRUM (55570-330-11) ",
      "NDC11Code": "55570-0330-11",
      "ProductNDC": "55570-330",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Manganese Gluconate Dihydrate",
      "DosageFormName": "GRANULE",
      "StartMarketingDate": "20080229",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Jost Chemical Co.",
      "SubstanceName": "MANGANESE GLUCONATE DIHYDRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "29-FEB-08"
    },
    {
      "NDCCode": "58177-330-11",
      "PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (58177-330-11)",
      "NDC11Code": "58177-0330-11",
      "ProductNDC": "58177-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100422",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076720",
      "LabelerName": "ETHEX Corporation",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).",
      "Description": "Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&C red #27/phloxine aluminum lake, FD&C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide."
    },
    {
      "NDCCode": "60687-330-21",
      "PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-330-21)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-330-11) ",
      "NDC11Code": "60687-0330-21",
      "ProductNDC": "60687-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tolterodine Tartrate",
      "NonProprietaryName": "Tolterodine",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170814",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203016",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "TOLTERODINE TARTRATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170814",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)].",
      "Description": "Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7. Its structure is:. Tolterodine tartrate, USP is a white, crystalline powder with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate 4 mg extended-release capsules, USP for oral administration contain 4 mg of tolterodine tartrate, USP. Inactive ingredients are cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Tolterodine tartrate 2 mg extended-release capsules, USP for oral administration contain 2 mg of tolterodine tartrate, USP, and the following inactive ingredients: cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, iron oxide yellow, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "62584-330-01",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (62584-330-01)  > 10 TABLET in 1 BLISTER PACK (62584-330-11)",
      "NDC11Code": "62584-0330-01",
      "ProductNDC": "62584-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlorpromazine Hydrochloride",
      "NonProprietaryName": "Chlorpromazine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100528",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA080439",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-03"
    },
    {
      "NDCCode": "63354-330-01",
      "PackageDescription": "11.8 g in 1 TUBE (63354-330-01) ",
      "NDC11Code": "63354-0330-01",
      "ProductNDC": "63354-330",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Banana Boat",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120104",
      "EndMarketingDate": "20171231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Edgewell Personal Care Brands, LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "1; 10; 5; .8; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "63354-330-02",
      "PackageDescription": "11.8 g in 1 TUBE (63354-330-02) ",
      "NDC11Code": "63354-0330-02",
      "ProductNDC": "63354-330",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Banana Boat",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120104",
      "EndMarketingDate": "20171231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Edgewell Personal Care Brands, LLC",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "1; 10; 5; .8; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "68084-330-01",
      "PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-330-01)  > 1 TABLET in 1 BLISTER PACK (68084-330-11)",
      "NDC11Code": "68084-0330-01",
      "ProductNDC": "68084-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090113",
      "EndMarketingDate": "20160630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077653",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "68428-330-11",
      "PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-330-11) ",
      "NDC11Code": "68428-0330-11",
      "ProductNDC": "68428-330",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coccus Cacti",
      "NonProprietaryName": "Protortonia Cacti",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100324",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "PROTORTONIA CACTI",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100324",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68462-330-11",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (68462-330-11)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "68462-0330-11",
      "ProductNDC": "68462-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090781",
      "LabelerName": "Glenmark Pharmaceuticals Inc., USA",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": ".125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101008",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) (1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
      "Description": "Pramipexole Dihydrochloride Tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride, USP is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S.2HCl.H2O, and its molecular weight is 302.26. The structural formula is:. Pramipexole dihydrochloride, USP is a white to off-white powder. Melting occurs in the range of 296°C to 298°C. Pramipexole dihydrochloride, USP is soluble in methanol and water. Pramipexole Dihydrochloride Tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride, USP. Inactive ingredients consist of mannitol, corn starch, colloidal silicon dioxide, povidone K-30, and magnesium stearate."
    },
    {
      "NDCCode": "70257-330-51",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (70257-330-51)  / 1 LIQUID in 1 VIAL, SINGLE-DOSE (70257-330-11) ",
      "NDC11Code": "70257-0330-51",
      "ProductNDC": "70257-330",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Winrho Sdf",
      "NonProprietaryName": "Rho (d) Immune Globulin",
      "DosageFormName": "LIQUID",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20190301",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103649",
      "LabelerName": "Saol Therapeutics Inc.",
      "SubstanceName": "HUMAN RHO(D) IMMUNE GLOBULIN",
      "StrengthNumber": "1500",
      "StrengthUnit": "[iU]/1",
      "Pharm_Classes": "Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190301",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.",
      "Description": "WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA."
    },
    {
      "NDCCode": "73549-003-11",
      "PackageDescription": "330 mL in 1 BOTTLE (73549-003-11) ",
      "NDC11Code": "73549-0003-11",
      "ProductNDC": "73549-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Cleanser",
      "NonProprietaryName": "Hand Cleanser",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200503",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Fortress Expert Co., Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "76",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200503",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps reduce bacteria that potentially can cause disease. Helps prevent cross contamination by hand contact. Recommended for repeated use."
    },
    {
      "NDCCode": "76420-330-11",
      "PackageDescription": "10 TABLET in 1 BLISTER PACK (76420-330-11) ",
      "NDC11Code": "76420-0330-11",
      "ProductNDC": "76420-330",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loratadine Allergy Relief",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076134",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250419",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "43598-023-53",
      "PackageDescription": "1 KIT in 1 CARTON (43598-023-53)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "43598-0023-53",
      "ProductNDC": "43598-023",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Varenicline Tartrate",
      "NonProprietaryName": "Varenicline Tartrate",
      "DosageFormName": "KIT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215931",
      "LabelerName": "Dr. Reddys Laboratories Inc.",
      "Status": "Active",
      "LastUpdate": "2025-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
      "Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic receptor agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to slightly yellow color solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3] benzazepine, (2R,3R)-2,3-dihydroxybutanedioate. It is freely soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg modified capsule shape biconvex, orange colour, film-coated tablets debossed with “C2” on one side and plain on other side and free from physical defects and a 1 mg modified capsule shape biconvex, pink colour, film-coated tablets debossed with “C1\" on one side and plain on other side and free from physical defects. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline. The following inactive ingredients are included in the tablets: croscarmellose sodium, maltodextrin, microcrystalline cellulose, stearic acid, Opadry orange (for 0.5 mg), Opadry pink (for 1 mg)."
    },
    {
      "NDCCode": "43598-032-37",
      "PackageDescription": "10 CARTON in 1 BOX (43598-032-37)  / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11)  / .5 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "43598-0032-37",
      "ProductNDC": "43598-032",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phytonadione",
      "NonProprietaryName": "Phytonadione",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20261005",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215820",
      "LabelerName": "Dr.Reddys Laboratories Inc",
      "SubstanceName": "PHYTONADIONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/.5mL",
      "Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-10-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20261005",
      "SamplePackage": "N",
      "Description": "Phytonadione is a vitamin K replacement, which is an intense yellow viscous oily liquid. It is very soluble in ether, chloroform, and hexane; soluble in ethanol and very slightly soluble in water. It has a molecular weight of 450.7. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-enylnaphthalene-1,4-dione. Its molecular formula is C31H46O2 and its molecular structure is. Phytonadione Injectable Emulsion, USP injection is a clear yellow color, sterile solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0."
    },
    {
      "NDCCode": "43598-050-25",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (43598-050-25)  / 2 mL in 1 VIAL, MULTI-DOSE (43598-050-11) ",
      "NDC11Code": "43598-0050-25",
      "ProductNDC": "43598-050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Thiamine Hydrochloride",
      "NonProprietaryName": "Thiamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20230331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA080571",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "SubstanceName": "THIAMINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.",
      "Description": "Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride, USP in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride, USP 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; water for injection, q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH between 2.5 and 4.5. Thiamine hydrochloride, USP or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride, USP is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula."
    },
    {
      "NDCCode": "43598-051-11",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (43598-051-11)  / 2 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "43598-0051-11",
      "ProductNDC": "43598-051",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitonin Salmon",
      "NonProprietaryName": "Calcitonin Salmon",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "20240617",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215715",
      "LabelerName": "Dr. Reddy's Laboratories, Inc.",
      "SubstanceName": "CALCITONIN SALMON",
      "StrengthNumber": "200",
      "StrengthUnit": "[USP'U]/mL",
      "Pharm_Classes": "Calcitonin [CS], Calcitonin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240617",
      "SamplePackage": "N",
      "Description": "Calcitonin, USP is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin-salmon Injection, USP Synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula. It is provided in sterile solution for subcutaneous or intramuscular injection. Each milliliter contains: calcitonin-salmon 200 International Units. Inactive Ingredients (per mL): acetic acid, USP, 2.25 mg; phenol, USP, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP. The activity of calcitonin-salmon injection is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London."
    },
    {
      "NDCCode": "43598-053-11",
      "PackageDescription": "1 VIAL in 1 CARTON (43598-053-11)  > 10 mL in 1 VIAL",
      "NDC11Code": "43598-0053-11",
      "ProductNDC": "43598-053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20220912",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215961",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2022-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220912",
      "SamplePackage": "N",
      "Description": "Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1068.4. Molecular Formula: C46H64N14O12S2 C2H4O2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
    },
    {
      "NDCCode": "43598-061-58",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-061-58)  > 1 mL in 1 VIAL, SINGLE-DOSE (43598-061-11) ",
      "NDC11Code": "43598-0061-58",
      "ProductNDC": "43598-061",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ziprasidone Mesylate",
      "NonProprietaryName": "Ziprasidone Mesylate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220322",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211908",
      "LabelerName": "Dr.Reddy's Laboratories, Inc.",
      "SubstanceName": "ZIPRASIDONE MESYLATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and  sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Acute Treatment of Agitation in Schizophrenia: 1 Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation.",
      "Description": "Ziprasidone mesylate for injection is an atypical antipsychotic available as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS  CH3SO3H  3H2O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
    },
    {
      "NDCCode": "43598-078-58",
      "PackageDescription": "10 VIAL in 1 CARTON (43598-078-58)  / 1 mL in 1 VIAL (43598-078-11) ",
      "NDC11Code": "43598-0078-58",
      "ProductNDC": "43598-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Enalaprilat",
      "NonProprietaryName": "Enalaprilat",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230606",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075578",
      "LabelerName": "Dr. Reddys Laboratories Inc",
      "SubstanceName": "ENALAPRILAT",
      "StrengthNumber": "1.25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
      "Status": "Active",
      "LastUpdate": "2024-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230606",
      "SamplePackage": "N",
      "IndicationAndUsage": "Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalaprilat injection does not have a similar risk (see WARNINGS). In considering use of enalaprilat, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Angioedema).",
      "Description": "Enalaprilat injection, USP is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin-converting enzyme inhibitor. It is chemically described as (S)-1-[N-(1-carboxy-3-phenylpropyl)-L-alanyl]-L-proline dihydrate. Its molecular formula is C18H24N2O52H2O and its structural formula is. Enalaprilat, USP is a white or almost white crystalline powder with a molecular weight of 384.43. It is sparingly soluble in methanol and slightly soluble in water. Each milliliter of enalaprilat injection, USP contains 1.25 mg enalaprilat, USP (anhydrous equivalent); sodium chloride to adjust tonicity; sodium hydroxide to adjust pH; water for injection, q.s.; with benzyl alcohol, 9 mg, added as a preservative."
    },
    {
      "NDCCode": "43598-085-25",
      "PackageDescription": "25 VIAL in 1 CARTON (43598-085-25)  > 1 mL in 1 VIAL (43598-085-11) ",
      "NDC11Code": "43598-0085-25",
      "ProductNDC": "43598-085",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vasopressin",
      "NonProprietaryName": "Vasopressin",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20141112",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204485",
      "LabelerName": "DR. REDDYS LABORATORIES INC",
      "SubstanceName": "VASOPRESSIN, UNSPECIFIED",
      "StrengthNumber": "20",
      "StrengthUnit": "[USP'U]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220208",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
      "Description": "Vasopressin is a polypeptide hormone. Vasopressin injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer and Water for Injection, USP.  Sodium hydroxide and hydrochloric acid are included to adjust to a pH of 3.8. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2                 Molecular Weight: 1084.23. One mg is equivalent to 530 units."
    },
    {
      "NDCCode": "43598-087-58",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-087-58)  / 20 mL in 1 VIAL, SINGLE-DOSE (43598-087-11) ",
      "NDC11Code": "43598-0087-58",
      "ProductNDC": "43598-087",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lacosamide",
      "NonProprietaryName": "Lacosamide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240422",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217718",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "SubstanceName": "LACOSAMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2026-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240422",
      "SamplePackage": "N",
      "Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
    },
    {
      "NDCCode": "43598-097-30",
      "PackageDescription": "30 PACKET in 1 CARTON (43598-097-30)  / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11) ",
      "NDC11Code": "43598-0097-30",
      "ProductNDC": "43598-097",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Javygtor",
      "NonProprietaryName": "Sapropterin Dihydrochloride",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220916",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209452",
      "LabelerName": "Dr. Reddys Laboratories Inc",
      "SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220916",
      "SamplePackage": "N",
      "IndicationAndUsage": "JAVYGTOR (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.",
      "Description": "JAVYGTOR (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in JAVYGTOR, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is a white to off-white crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C9H15N5O3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. JAVYGTOR is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base) and 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). JAVYGTOR powder for oral solution is off white to pale yellow powder. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose."
    },
    {
      "NDCCode": "43598-106-10",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (43598-106-10)  / 2 mL in 1 SYRINGE, GLASS (43598-106-11) ",
      "NDC11Code": "43598-0106-10",
      "ProductNDC": "43598-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20240807",
      "EndMarketingDate": "20270723",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218422",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2026-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240807",
      "EndMarketingDatePackage": "20270723",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.",
      "Description": "Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative."
    },
    {
      "NDCCode": "43598-106-58",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (43598-106-58)  / 2 mL in 1 SYRINGE, GLASS (43598-106-11) ",
      "NDC11Code": "43598-0106-58",
      "ProductNDC": "43598-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20240807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218422",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260511",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.",
      "Description": "Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"43598-330-11","ProprietaryName":"Zoledronic Acid","NonProprietaryName":"Zoledronic Acid"},{"NDCCode":"46987-330-11","ProprietaryName":"Kadian","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"49591-330-51","ProprietaryName":"Winrho Sdf","NonProprietaryName":"Human Rho(d) Immune Globulin"},{"NDCCode":"50268-330-15","ProprietaryName":"Fludrocortisone Acetate","NonProprietaryName":"Fludrocortisone Acetate"},{"NDCCode":"50419-330-11","ProprietaryName":"Ambelvist","NonProprietaryName":"Gadoquatrane"},{"NDCCode":"54568-341-11","NonProprietaryName":"Tirzepatide"},{"NDCCode":"55570-330-11","NonProprietaryName":"Manganese Gluconate Dihydrate"},{"NDCCode":"58177-330-11","ProprietaryName":"Morphine Sulfate","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"60687-330-21","ProprietaryName":"Tolterodine Tartrate","NonProprietaryName":"Tolterodine"},{"NDCCode":"62584-330-01","ProprietaryName":"Chlorpromazine Hydrochloride","NonProprietaryName":"Chlorpromazine Hydrochloride"},{"NDCCode":"63354-330-01","ProprietaryName":"Banana Boat","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone"},{"NDCCode":"63354-330-02","ProprietaryName":"Banana Boat","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone"},{"NDCCode":"68084-330-01","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"68428-330-11","ProprietaryName":"Coccus Cacti","NonProprietaryName":"Protortonia Cacti"},{"NDCCode":"68462-330-11","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"70257-330-51","ProprietaryName":"Winrho Sdf","NonProprietaryName":"Rho (d) Immune Globulin"},{"NDCCode":"73549-003-11","ProprietaryName":"Hand Cleanser","NonProprietaryName":"Hand Cleanser"},{"NDCCode":"76420-330-11","ProprietaryName":"Loratadine Allergy Relief","NonProprietaryName":"Loratadine"},{"NDCCode":"43598-023-53","ProprietaryName":"Varenicline Tartrate","NonProprietaryName":"Varenicline Tartrate"},{"NDCCode":"43598-032-37","ProprietaryName":"Phytonadione","NonProprietaryName":"Phytonadione"},{"NDCCode":"43598-050-25","ProprietaryName":"Thiamine Hydrochloride","NonProprietaryName":"Thiamine Hydrochloride"},{"NDCCode":"43598-051-11","ProprietaryName":"Calcitonin Salmon","NonProprietaryName":"Calcitonin Salmon"},{"NDCCode":"43598-053-11","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"43598-061-58","ProprietaryName":"Ziprasidone Mesylate","NonProprietaryName":"Ziprasidone Mesylate"},{"NDCCode":"43598-078-58","ProprietaryName":"Enalaprilat","NonProprietaryName":"Enalaprilat"},{"NDCCode":"43598-085-25","ProprietaryName":"Vasopressin","NonProprietaryName":"Vasopressin"},{"NDCCode":"43598-087-58","ProprietaryName":"Lacosamide","NonProprietaryName":"Lacosamide"},{"NDCCode":"43598-097-30","ProprietaryName":"Javygtor","NonProprietaryName":"Sapropterin Dihydrochloride"},{"NDCCode":"43598-106-10","ProprietaryName":"Diazepam","NonProprietaryName":"Diazepam"},{"NDCCode":"43598-106-58","ProprietaryName":"Diazepam","NonProprietaryName":"Diazepam"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>43598-330-11</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (43598-330-11)  / 5 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>43598-0330-11</NDC11Code>
    <ProductNDC>43598-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zoledronic Acid</ProprietaryName>
    <NonProprietaryName>Zoledronic Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130819</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091186</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
    <SubstanceName>ZOLEDRONIC ACID</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zoledronic acid injection is a bisphosphonate indicated for the treatment of: 1 Hypercalcemia of malignancy. (1.1), 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)  .</IndicationAndUsage>
    <Description>Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is. Zoledronic acid is white to almost white crystalline solid. Its molecular formula is C5H10N2O7P2  H2O and its molar mass is 290.1g/mol. Zoledronic acid is sparingly soluble in 0.1N sodium hydroxide solution. The pH of a 0.7% aqueous solution of zoledronic acid is between 1.5 and 2.5. Zoledronic acid injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg zoledronic acid monohydrate, USP corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and 24 mg of sodium citrate, USP. Inactive Ingredients: mannitol, USP, as bulking agent, sodium citrate, USP, as buffering agent and water for injection as vehicle.</Description>
  </NDC>
  <NDC>
    <NDCCode>46987-330-11</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46987-330-11)</PackageDescription>
    <NDC11Code>46987-0330-11</NDC11Code>
    <ProductNDC>46987-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kadian</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120507</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020616</ApplicationNumber>
    <LabelerName>Actavis Kadian LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49591-330-51</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (49591-330-51)  / 1.3 mL in 1 VIAL, GLASS (49591-330-11) </PackageDescription>
    <NDC11Code>49591-0330-51</NDC11Code>
    <ProductNDC>49591-330</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Winrho Sdf</ProprietaryName>
    <NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103649</ApplicationNumber>
    <LabelerName>Kamada Ltd.</LabelerName>
    <SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>[iU]/1.3mL</StrengthUnit>
    <Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.</IndicationAndUsage>
    <Description>WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA.</Description>
  </NDC>
  <NDC>
    <NDCCode>50268-330-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-330-15)  / 1 TABLET in 1 BLISTER PACK (50268-330-11) </PackageDescription>
    <NDC11Code>50268-0330-15</NDC11Code>
    <ProductNDC>50268-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fludrocortisone Acetate</ProprietaryName>
    <NonProprietaryName>Fludrocortisone Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040431</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>FLUDROCORTISONE ACETATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fludrocortisone acetate tablets USP, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.</IndicationAndUsage>
    <Description>Fludrocortisone Acetate Tablets USP, 0.1 mg contain fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The chemical name for fludrocortisone acetate is 9-fluoro-11β, 17, 21-trihydroxypregn-4-ene-3, 20- dione 21-acetate; its structural formula is. Fludrocortisone acetate tablets USP, 0.1 mg are available for oral administration as scored tablets providing 0.1 mg fludrocortisone acetate per tablet. Inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, and microcrystalline cellulose NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>50419-330-11</NDCCode>
    <PackageDescription>5 SYRINGE in 1 CARTON (50419-330-11)  / 7.5 mL in 1 SYRINGE (50419-330-01) </PackageDescription>
    <NDC11Code>50419-0330-11</NDC11Code>
    <ProductNDC>50419-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ambelvist</ProprietaryName>
    <NonProprietaryName>Gadoquatrane</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260612</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219627</ApplicationNumber>
    <LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GADOQUATRANE</SubstanceName>
    <StrengthNumber>257.9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: : 1 the central nervous system (brain, spine, and associated tissues) , 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) .</IndicationAndUsage>
    <Description>AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use. The chemical name for gadoquatrane is tetragadolinium [4,10-bis(carboxylatomethyl)-7-{3,6,12,15-tetraoxo-16-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]-9,9-bis({[({2-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]propanoyl}amino)acetyl]-amino}methyl)-4,7,11,14-tetraazaheptadecan-2-yl}-1,4,7,10-tetraazacyclododecan-1-yl]acetate, with a molecular formula of C81H128Gd4N24O32 and a molecular weight of 2,579.1 g/mol. The structural formula of gadoquatrane is. AMBELVIST is a sterile, clear, colorless to pale yellow solution. Each mL contains 257.9 mg (0.1 mmol) of gadoquatrane (containing 0.4 mmol of gadolinium) and the following inactive ingredients: 0.196 mg of calcobutrol, 3.14 mg of sodium chloride,1.21 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. The main physicochemical properties of AMBELVIST are listed in Table 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>54568-341-11</NDCCode>
    <PackageDescription>30 BOX in 1 BOX (54568-341-11)  / 330 CARTRIDGE in 1 BOX / 2.4 mL in 1 CARTRIDGE</PackageDescription>
    <NDC11Code>54568-0341-11</NDC11Code>
    <ProductNDC>54568-341</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Tirzepatide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20240206</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Eli Lilly Italia SPA</LabelerName>
    <SubstanceName>TIRZEPATIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/.6mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-08-24</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-AUG-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>55570-330-11</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (55570-330-11) </PackageDescription>
    <NDC11Code>55570-0330-11</NDC11Code>
    <ProductNDC>55570-330</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Manganese Gluconate Dihydrate</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <StartMarketingDate>20080229</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Jost Chemical Co.</LabelerName>
    <SubstanceName>MANGANESE GLUCONATE DIHYDRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-FEB-08</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>58177-330-11</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (58177-330-11)</PackageDescription>
    <NDC11Code>58177-0330-11</NDC11Code>
    <ProductNDC>58177-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076720</ApplicationNumber>
    <LabelerName>ETHEX Corporation</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic. Morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, controlled-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only. Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established. Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild, or not expected to persist for an extended period of time. Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).</IndicationAndUsage>
    <Description>Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate extended-release tablets are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP). Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, stearic acid, and titanium dioxide. The 15 mg tablet also contains: D&amp;C yellow #10 aluminum lake, FD&amp;C blue #1 aluminum lake, hydrated alumina and polysorbate. The 30 mg tablet also contains: D&amp;C red #27/phloxine aluminum lake, FD&amp;C blue #1/FCD aluminum lake, lactose anhydrous and polysorbate. The 60 mg tablet also contains: lactose anhydrous and polysorbate. The 100 mg tablet also contains: black iron oxide, lactose monohydrate and polysorbate 80. The 200 mg tablet also contains: black iron oxide, lactose monohydrate, red iron oxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60687-330-21</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-330-21)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-330-11) </PackageDescription>
    <NDC11Code>60687-0330-21</NDC11Code>
    <ProductNDC>60687-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170814</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203016</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)].</IndicationAndUsage>
    <Description>Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7. Its structure is:. Tolterodine tartrate, USP is a white, crystalline powder with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate 4 mg extended-release capsules, USP for oral administration contain 4 mg of tolterodine tartrate, USP. Inactive ingredients are cellulose microcrystalline, ethyl cellulose, FD &amp; C blue 2, gelatin, hypromellose, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Tolterodine tartrate 2 mg extended-release capsules, USP for oral administration contain 2 mg of tolterodine tartrate, USP, and the following inactive ingredients: cellulose microcrystalline, ethyl cellulose, FD &amp; C blue 2, gelatin, hypromellose, iron oxide yellow, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>62584-330-01</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (62584-330-01)  &gt; 10 TABLET in 1 BLISTER PACK (62584-330-11)</PackageDescription>
    <NDC11Code>62584-0330-01</NDC11Code>
    <ProductNDC>62584-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100528</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA080439</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63354-330-01</NDCCode>
    <PackageDescription>11.8 g in 1 TUBE (63354-330-01) </PackageDescription>
    <NDC11Code>63354-0330-01</NDC11Code>
    <ProductNDC>63354-330</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Banana Boat</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120104</StartMarketingDate>
    <EndMarketingDate>20171231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Edgewell Personal Care Brands, LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>1; 10; 5; .8; 4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63354-330-02</NDCCode>
    <PackageDescription>11.8 g in 1 TUBE (63354-330-02) </PackageDescription>
    <NDC11Code>63354-0330-02</NDC11Code>
    <ProductNDC>63354-330</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Banana Boat</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120104</StartMarketingDate>
    <EndMarketingDate>20171231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Edgewell Personal Care Brands, LLC</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>1; 10; 5; .8; 4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68084-330-01</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-330-01)  &gt; 1 TABLET in 1 BLISTER PACK (68084-330-11)</PackageDescription>
    <NDC11Code>68084-0330-01</NDC11Code>
    <ProductNDC>68084-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090113</StartMarketingDate>
    <EndMarketingDate>20160630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077653</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>68428-330-11</NDCCode>
    <PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-330-11) </PackageDescription>
    <NDC11Code>68428-0330-11</NDC11Code>
    <ProductNDC>68428-330</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coccus Cacti</ProprietaryName>
    <NonProprietaryName>Protortonia Cacti</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100324</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>PROTORTONIA CACTI</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68462-330-11</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (68462-330-11)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68462-0330-11</NDC11Code>
    <ProductNDC>68462-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090781</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) (1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole Dihydrochloride Tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride, USP is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S.2HCl.H2O, and its molecular weight is 302.26. The structural formula is:. Pramipexole dihydrochloride, USP is a white to off-white powder. Melting occurs in the range of 296°C to 298°C. Pramipexole dihydrochloride, USP is soluble in methanol and water. Pramipexole Dihydrochloride Tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride, USP. Inactive ingredients consist of mannitol, corn starch, colloidal silicon dioxide, povidone K-30, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70257-330-51</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (70257-330-51)  / 1 LIQUID in 1 VIAL, SINGLE-DOSE (70257-330-11) </PackageDescription>
    <NDC11Code>70257-0330-51</NDC11Code>
    <ProductNDC>70257-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Winrho Sdf</ProprietaryName>
    <NonProprietaryName>Rho (d) Immune Globulin</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20190301</StartMarketingDate>
    <EndMarketingDate>20250531</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103649</ApplicationNumber>
    <LabelerName>Saol Therapeutics Inc.</LabelerName>
    <SubstanceName>HUMAN RHO(D) IMMUNE GLOBULIN</SubstanceName>
    <StrengthNumber>1500</StrengthNumber>
    <StrengthUnit>[iU]/1</StrengthUnit>
    <Pharm_Classes>Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.</IndicationAndUsage>
    <Description>WinRho ®SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh o(D) antigen (D antigen). WinRho ®SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization. WinRho ®SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and octoxynol) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a 20N virus filter, is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in Table 6. The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram (mcg)” dose. Potency and dosing recommendations are now expressed in IU by comparison to the WHO anti-Rh o(D) standard. The conversion of mcg to IU is: 1 mcg = 5 IU. A 1,500 IU (300 mcg) vial contains sufficient anti-Rh o(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o(D) (D-positive) RBCs. The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho ®SDF does not contain mercury. This product contains ≤ 40 mcg/mL IgA.</Description>
  </NDC>
  <NDC>
    <NDCCode>73549-003-11</NDCCode>
    <PackageDescription>330 mL in 1 BOTTLE (73549-003-11) </PackageDescription>
    <NDC11Code>73549-0003-11</NDC11Code>
    <ProductNDC>73549-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Cleanser</ProprietaryName>
    <NonProprietaryName>Hand Cleanser</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200503</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Fortress Expert Co., Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>76</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200503</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps reduce bacteria that potentially can cause disease. Helps prevent cross contamination by hand contact. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>76420-330-11</NDCCode>
    <PackageDescription>10 TABLET in 1 BLISTER PACK (76420-330-11) </PackageDescription>
    <NDC11Code>76420-0330-11</NDC11Code>
    <ProductNDC>76420-330</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Loratadine Allergy Relief</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076134</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-05-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43598-023-53</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (43598-023-53)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>43598-0023-53</NDC11Code>
    <ProductNDC>43598-023</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215931</ApplicationNumber>
    <LabelerName>Dr. Reddys Laboratories Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic receptor agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to slightly yellow color solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3] benzazepine, (2R,3R)-2,3-dihydroxybutanedioate. It is freely soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg modified capsule shape biconvex, orange colour, film-coated tablets debossed with “C2” on one side and plain on other side and free from physical defects and a 1 mg modified capsule shape biconvex, pink colour, film-coated tablets debossed with “C1" on one side and plain on other side and free from physical defects. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline. The following inactive ingredients are included in the tablets: croscarmellose sodium, maltodextrin, microcrystalline cellulose, stearic acid, Opadry orange (for 0.5 mg), Opadry pink (for 1 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-032-37</NDCCode>
    <PackageDescription>10 CARTON in 1 BOX (43598-032-37)  / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11)  / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>43598-0032-37</NDC11Code>
    <ProductNDC>43598-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phytonadione</ProprietaryName>
    <NonProprietaryName>Phytonadione</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20261005</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215820</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>PHYTONADIONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261005</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Phytonadione is a vitamin K replacement, which is an intense yellow viscous oily liquid. It is very soluble in ether, chloroform, and hexane; soluble in ethanol and very slightly soluble in water. It has a molecular weight of 450.7. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-enylnaphthalene-1,4-dione. Its molecular formula is C31H46O2 and its molecular structure is. Phytonadione Injectable Emulsion, USP injection is a clear yellow color, sterile solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-050-25</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (43598-050-25)  / 2 mL in 1 VIAL, MULTI-DOSE (43598-050-11) </PackageDescription>
    <NDC11Code>43598-0050-25</NDC11Code>
    <ProductNDC>43598-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Thiamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20230331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA080571</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
    <SubstanceName>THIAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.</IndicationAndUsage>
    <Description>Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride, USP in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride, USP 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; water for injection, q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH between 2.5 and 4.5. Thiamine hydrochloride, USP or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride, USP is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-051-11</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (43598-051-11)  / 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>43598-0051-11</NDC11Code>
    <ProductNDC>43598-051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcitonin Salmon</ProprietaryName>
    <NonProprietaryName>Calcitonin Salmon</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240617</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215715</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
    <SubstanceName>CALCITONIN SALMON</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Calcitonin [CS], Calcitonin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240617</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Calcitonin, USP is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin-salmon Injection, USP Synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula. It is provided in sterile solution for subcutaneous or intramuscular injection. Each milliliter contains: calcitonin-salmon 200 International Units. Inactive Ingredients (per mL): acetic acid, USP, 2.25 mg; phenol, USP, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP. The activity of calcitonin-salmon injection is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-053-11</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (43598-053-11)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>43598-0053-11</NDC11Code>
    <ProductNDC>43598-053</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20220912</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215961</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1068.4. Molecular Formula: C46H64N14O12S2 C2H4O2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-061-58</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (43598-061-58)  &gt; 1 mL in 1 VIAL, SINGLE-DOSE (43598-061-11) </PackageDescription>
    <NDC11Code>43598-0061-58</NDC11Code>
    <ProductNDC>43598-061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziprasidone Mesylate</ProprietaryName>
    <NonProprietaryName>Ziprasidone Mesylate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20220322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211908</ApplicationNumber>
    <LabelerName>Dr.Reddy's Laboratories, Inc.</LabelerName>
    <SubstanceName>ZIPRASIDONE MESYLATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and  sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]Acute Treatment of Agitation in Schizophrenia: 1 Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation.</IndicationAndUsage>
    <Description>Ziprasidone mesylate for injection is an atypical antipsychotic available as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS  CH3SO3H  3H2O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-078-58</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (43598-078-58)  / 1 mL in 1 VIAL (43598-078-11) </PackageDescription>
    <NDC11Code>43598-0078-58</NDC11Code>
    <ProductNDC>43598-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enalaprilat</ProprietaryName>
    <NonProprietaryName>Enalaprilat</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230606</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075578</ApplicationNumber>
    <LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
    <SubstanceName>ENALAPRILAT</SubstanceName>
    <StrengthNumber>1.25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalaprilat injection does not have a similar risk (see WARNINGS). In considering use of enalaprilat, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Angioedema).</IndicationAndUsage>
    <Description>Enalaprilat injection, USP is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin-converting enzyme inhibitor. It is chemically described as (S)-1-[N-(1-carboxy-3-phenylpropyl)-L-alanyl]-L-proline dihydrate. Its molecular formula is C18H24N2O52H2O and its structural formula is. Enalaprilat, USP is a white or almost white crystalline powder with a molecular weight of 384.43. It is sparingly soluble in methanol and slightly soluble in water. Each milliliter of enalaprilat injection, USP contains 1.25 mg enalaprilat, USP (anhydrous equivalent); sodium chloride to adjust tonicity; sodium hydroxide to adjust pH; water for injection, q.s.; with benzyl alcohol, 9 mg, added as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-085-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (43598-085-25)  &gt; 1 mL in 1 VIAL (43598-085-11) </PackageDescription>
    <NDC11Code>43598-0085-25</NDC11Code>
    <ProductNDC>43598-085</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vasopressin</ProprietaryName>
    <NonProprietaryName>Vasopressin</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20141112</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204485</ApplicationNumber>
    <LabelerName>DR. REDDYS LABORATORIES INC</LabelerName>
    <SubstanceName>VASOPRESSIN, UNSPECIFIED</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
    <Description>Vasopressin is a polypeptide hormone. Vasopressin injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer and Water for Injection, USP.  Sodium hydroxide and hydrochloric acid are included to adjust to a pH of 3.8. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2                 Molecular Weight: 1084.23. One mg is equivalent to 530 units.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-087-58</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-087-58)  / 20 mL in 1 VIAL, SINGLE-DOSE (43598-087-11) </PackageDescription>
    <NDC11Code>43598-0087-58</NDC11Code>
    <ProductNDC>43598-087</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lacosamide</ProprietaryName>
    <NonProprietaryName>Lacosamide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240422</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217718</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
    <SubstanceName>LACOSAMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-097-30</NDCCode>
    <PackageDescription>30 PACKET in 1 CARTON (43598-097-30)  / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11) </PackageDescription>
    <NDC11Code>43598-0097-30</NDC11Code>
    <ProductNDC>43598-097</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Javygtor</ProprietaryName>
    <NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220916</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209452</ApplicationNumber>
    <LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
    <SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JAVYGTOR (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.</IndicationAndUsage>
    <Description>JAVYGTOR (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in JAVYGTOR, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is a white to off-white crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C9H15N5O3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. JAVYGTOR is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base) and 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). JAVYGTOR powder for oral solution is off white to pale yellow powder. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-106-10</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (43598-106-10)  / 2 mL in 1 SYRINGE, GLASS (43598-106-11) </PackageDescription>
    <NDC11Code>43598-0106-10</NDC11Code>
    <ProductNDC>43598-106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20240807</StartMarketingDate>
    <EndMarketingDate>20270723</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218422</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240807</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270723</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.</IndicationAndUsage>
    <Description>Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-106-58</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (43598-106-58)  / 2 mL in 1 SYRINGE, GLASS (43598-106-11) </PackageDescription>
    <NDC11Code>43598-0106-58</NDC11Code>
    <ProductNDC>43598-106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20240807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218422</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.</IndicationAndUsage>
    <Description>Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>43598-330-11</NDCCode><ProprietaryName>Zoledronic Acid</ProprietaryName><NonProprietaryName>Zoledronic Acid</NonProprietaryName></NDC><NDC><NDCCode>46987-330-11</NDCCode><ProprietaryName>Kadian</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>49591-330-51</NDCCode><ProprietaryName>Winrho Sdf</ProprietaryName><NonProprietaryName>Human Rho(d) Immune Globulin</NonProprietaryName></NDC><NDC><NDCCode>50268-330-15</NDCCode><ProprietaryName>Fludrocortisone Acetate</ProprietaryName><NonProprietaryName>Fludrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>50419-330-11</NDCCode><ProprietaryName>Ambelvist</ProprietaryName><NonProprietaryName>Gadoquatrane</NonProprietaryName></NDC><NDC><NDCCode>54568-341-11</NDCCode><NonProprietaryName>Tirzepatide</NonProprietaryName></NDC><NDC><NDCCode>55570-330-11</NDCCode><NonProprietaryName>Manganese Gluconate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>58177-330-11</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>60687-330-21</NDCCode><ProprietaryName>Tolterodine Tartrate</ProprietaryName><NonProprietaryName>Tolterodine</NonProprietaryName></NDC><NDC><NDCCode>62584-330-01</NDCCode><ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName><NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63354-330-01</NDCCode><ProprietaryName>Banana Boat</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>63354-330-02</NDCCode><ProprietaryName>Banana Boat</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>68084-330-01</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68428-330-11</NDCCode><ProprietaryName>Coccus Cacti</ProprietaryName><NonProprietaryName>Protortonia Cacti</NonProprietaryName></NDC><NDC><NDCCode>68462-330-11</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70257-330-51</NDCCode><ProprietaryName>Winrho Sdf</ProprietaryName><NonProprietaryName>Rho (d) Immune Globulin</NonProprietaryName></NDC><NDC><NDCCode>73549-003-11</NDCCode><ProprietaryName>Hand Cleanser</ProprietaryName><NonProprietaryName>Hand Cleanser</NonProprietaryName></NDC><NDC><NDCCode>76420-330-11</NDCCode><ProprietaryName>Loratadine Allergy Relief</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>43598-023-53</NDCCode><ProprietaryName>Varenicline Tartrate</ProprietaryName><NonProprietaryName>Varenicline Tartrate</NonProprietaryName></NDC><NDC><NDCCode>43598-032-37</NDCCode><ProprietaryName>Phytonadione</ProprietaryName><NonProprietaryName>Phytonadione</NonProprietaryName></NDC><NDC><NDCCode>43598-050-25</NDCCode><ProprietaryName>Thiamine Hydrochloride</ProprietaryName><NonProprietaryName>Thiamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43598-051-11</NDCCode><ProprietaryName>Calcitonin Salmon</ProprietaryName><NonProprietaryName>Calcitonin Salmon</NonProprietaryName></NDC><NDC><NDCCode>43598-053-11</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>43598-061-58</NDCCode><ProprietaryName>Ziprasidone Mesylate</ProprietaryName><NonProprietaryName>Ziprasidone Mesylate</NonProprietaryName></NDC><NDC><NDCCode>43598-078-58</NDCCode><ProprietaryName>Enalaprilat</ProprietaryName><NonProprietaryName>Enalaprilat</NonProprietaryName></NDC><NDC><NDCCode>43598-085-25</NDCCode><ProprietaryName>Vasopressin</ProprietaryName><NonProprietaryName>Vasopressin</NonProprietaryName></NDC><NDC><NDCCode>43598-087-58</NDCCode><ProprietaryName>Lacosamide</ProprietaryName><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>43598-097-30</NDCCode><ProprietaryName>Javygtor</ProprietaryName><NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43598-106-10</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>43598-106-58</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

            
{
  "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",
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      "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 ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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",
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      "TaxonomyCode1": "171M00000X",
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  ]
}
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