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How to Find 21130-685-30 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "21130-685-30",
      "PackageDescription": "100 PACKET in 1 BOX (21130-685-30)  / 1 APPLICATOR in 1 PACKET (21130-685-09)  / 5 mL in 1 APPLICATOR",
      "NDC11Code": "21130-0685-30",
      "ProductNDC": "21130-685",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Signature Care Alcohol Prep Pad",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200831",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Better Living Brands LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N",
      "IndicationAndUsage": " first aid antiseptic to prevent infection in minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "13537-685-02",
      "PackageDescription": "1 BOTTLE in 1 BOX (13537-685-02)  > 30 mL in 1 BOTTLE (13537-685-01)",
      "NDC11Code": "13537-0685-02",
      "ProductNDC": "13537-685",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm",
      "ProprietaryNameSuffix": "Medium 5 - Beige",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151123",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": ".07; .0244",
      "StrengthUnit": "g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "13811-685-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (13811-685-30)",
      "NDC11Code": "13811-0685-30",
      "ProductNDC": "13811-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine And Valsartan",
      "NonProprietaryName": "Amlodipine And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202713",
      "LabelerName": "Trigen Laboratories, LLC",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
      "StrengthNumber": "5; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-22"
    },
    {
      "NDCCode": "14141-685-02",
      "PackageDescription": "1 BOTTLE in 1 BOX (14141-685-02)  / 30 mL in 1 BOTTLE (14141-685-01) ",
      "NDC11Code": "14141-0685-02",
      "ProductNDC": "14141-685",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm",
      "ProprietaryNameSuffix": "Medium 5 - Beige",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191202",
      "EndMarketingDate": "20240315",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Bel Star S.A. (Colombia)",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": ".07; .0244",
      "StrengthUnit": "g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-03-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191202",
      "EndMarketingDatePackage": "20240315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16571-685-03",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (16571-685-03) ",
      "NDC11Code": "16571-0685-03",
      "ProductNDC": "16571-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clomipramine Hydrochloride",
      "NonProprietaryName": "Clomipramine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212285",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
      "Description": "Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. D&C Yellow 10, FD&C Red 40, FD&C Blue 1 (50 mg capsules only), gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, black iron oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "16590-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16590-685-30)",
      "NDC11Code": "16590-0685-30",
      "ProductNDC": "16590-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078858",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.",
      "Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.                          250 mg tablets: FD&C Blue # 2 Lake of indigo carmine.                          500 mg tablets: Ferric oxide yellow.                          750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow."
    },
    {
      "NDCCode": "16714-685-01",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-685-01) ",
      "NDC11Code": "16714-0685-01",
      "ProductNDC": "16714-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077691",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20061220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red."
    },
    {
      "NDCCode": "33261-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-685-30)",
      "NDC11Code": "33261-0685-30",
      "ProductNDC": "33261-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
      "NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085762",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE",
      "StrengthNumber": "2.5; .025",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea.",
      "Description": "Each tablet for oral administration contains. diphenoxylatehydrochloride, USP 2.5 mg(Warning – May be habit forming). atropinesulfate, USP 0.025 mg. Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3, 3-diphenylpropyl)-4-phenyl-isonipecotate monohydrochloride and has the following structure. Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structure. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid."
    },
    {
      "NDCCode": "35356-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (35356-685-30) ",
      "NDC11Code": "35356-0685-30",
      "ProductNDC": "35356-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nabumetone",
      "NonProprietaryName": "Nabumentone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075280",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "NABUMETONE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20020225",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43063-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-685-30) ",
      "NDC11Code": "43063-0685-30",
      "ProductNDC": "43063-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160412",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202991",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "7.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20160628",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43598-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (43598-685-30) ",
      "NDC11Code": "43598-0685-30",
      "ProductNDC": "43598-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eslicarbazepine Acetate",
      "NonProprietaryName": "Eslicarbazepine Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250506",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211238",
      "LabelerName": "Dr.Reddys Laboratories Inc",
      "SubstanceName": "ESLICARBAZEPINE ACETATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250506",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
      "Description": "The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5Hdibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is. Eslicarbazepine acetate is a white to off-white crystalline powder. It is soluble in dichloromethane and sparingly soluble in methanol. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, hydroxyl propyl methyl cellulose, magnesium stearate and microcrystalline cellulose."
    },
    {
      "NDCCode": "45865-685-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (45865-685-30)",
      "NDC11Code": "45865-0685-30",
      "ProductNDC": "45865-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "Medsource Pharmaceuticals",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK a of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride is supplied as a 5 mg, 7.5 mg and 10 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "47335-685-83",
      "PackageDescription": "30 TABLET in 1 BOTTLE (47335-685-83) ",
      "NDC11Code": "47335-0685-83",
      "ProductNDC": "47335-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lurasidone Hydrochloride",
      "NonProprietaryName": "Lurasidone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208066",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "LURASIDONE HYDROCHLORIDE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
      "Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its  chemical  name  is  (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1­ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, alginic acid, pregelatinized corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and carnauba wax. The 80 mg tablets also contain yellow iron oxide, FD&C Blue#1 aluminum lake and black iron oxide."
    },
    {
      "NDCCode": "51655-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, DISPENSING (51655-685-30)",
      "NDC11Code": "51655-0685-30",
      "ProductNDC": "51655-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen Sodium",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140826",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078250",
      "LabelerName": "Northwind Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritisFor the relief of the signs and symptoms of osteoarthritisFor the relief of the signs and symptoms of ankylosing spondylitisFor the relief of the signs and symptoms of juvenile arthritis. Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen as naproxen and naproxen sodium tablets are also indicated. For relief of the signs and symptoms of tendonitisFor relief of the signs and symptoms of bursitisFor relief of the signs and symptoms of acute goutFor the management of painFor the management of primary dysmenorrhea.",
      "Description": "Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544."
    },
    {
      "NDCCode": "52083-685-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (52083-685-01)  > 30 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "52083-0685-01",
      "ProductNDC": "52083-685",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Abanatuss Ped Drops",
      "NonProprietaryName": "Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150805",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "KRAMER NOVIS",
      "SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "6.25; .5; 15",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20150805",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52125-685-02",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (52125-685-02)",
      "NDC11Code": "52125-0685-02",
      "ProductNDC": "52125-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenytoin Sodium",
      "NonProprietaryName": "Phenytoin Sodium",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130827",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040684",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "PHENYTOIN SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-02"
    },
    {
      "NDCCode": "55700-685-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-685-30) ",
      "NDC11Code": "55700-0685-30",
      "ProductNDC": "55700-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ropinirole Hydrochloride",
      "NonProprietaryName": "Ropinirole Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180914",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078110",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "ROPINIROLE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180914",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59651-685-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-685-30) ",
      "NDC11Code": "59651-0685-30",
      "ProductNDC": "59651-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tofacitinib",
      "NonProprietaryName": "Tofacitinib",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260603",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218462",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "TOFACITINIB CITRATE",
      "StrengthNumber": "11",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260603",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tofacitinib extended-release tablets are Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. , 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. , 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. .",
      "Description": "Tofacitinib extended-release tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white crystalline powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib extended-release tablets are supplied for oral administration as a 11 mg pink, oval, bevel edged, mat finished film-coated extended-release tablets imprinted with “TI11” on one side and plain on other side. Each 11 mg tablet of tofacitinib extended-release tablet contains 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) and the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene oxide, titanium dioxide and triacetin. Printing ink contains, iron oxide black, propylene glycol, and shellac glaze."
    },
    {
      "NDCCode": "61919-685-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61919-685-30) ",
      "NDC11Code": "61919-0685-30",
      "ProductNDC": "61919-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078154",
      "LabelerName": "DIRECT RX",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20140101",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Partial Onset Seizures. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.",
      "Description": "Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue No. 2 Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&C Blue No. 2 Aluminum Lake, FD&C yellow No.6 Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "66096-685-02",
      "PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-685-02)",
      "NDC11Code": "66096-0685-02",
      "ProductNDC": "66096-685",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rejuvenate 2000 Pm Formula For Women",
      "NonProprietaryName": "Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.",
      "DosageFormName": "SPRAY",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "OHM PHARMA INC.",
      "SubstanceName": "SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC",
      "StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12",
      "StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "USES: Temporarily relieves symptoms of low energy and occasional sleeplessness."
    },
    {
      "NDCCode": "66993-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (66993-685-30) ",
      "NDC11Code": "66993-0685-30",
      "ProductNDC": "66993-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120423",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202050",
      "LabelerName": "Prasco Laboratories",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120423",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
      "Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. Meets USP dissolution test 2."
    },
    {
      "NDCCode": "68083-685-01",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-685-01)  / 30 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "68083-0685-01",
      "ProductNDC": "68083-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epinephrine",
      "NonProprietaryName": "Epinephrine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20251002",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219239",
      "LabelerName": "Gland Pharma Limited",
      "SubstanceName": "EPINEPHRINE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251002",
      "SamplePackage": "N",
      "IndicationAndUsage": "Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: 1 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.1) , 2 For emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.2) .",
      "Description": "Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine. 10 mL Multiple Dose Vial: 10 mL multiple dose amber glass vial containing 10 mg/10 mL (1 mg/mL) epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 10 mL vial, each 1 mL of Epinephrine Injection, USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2 to 5.0. 30 mL Multiple Dose Vial. 30 mL multiple dose amber glass vial containing 30 mg/30 mL epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 30 mL vial, each 1 mL of Epinephrine Injection USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
    },
    {
      "NDCCode": "69097-685-02",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-685-02) ",
      "NDC11Code": "69097-0685-02",
      "ProductNDC": "69097-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin Capsules, Cv",
      "NonProprietaryName": "Pregabalin Capsules, Cv",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200110",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212280",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200110",
      "SamplePackage": "N",
      "IndicationAndUsage": ". Pregabalin capsules are indicated for.  : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
    },
    {
      "NDCCode": "71610-685-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (71610-685-30) ",
      "NDC11Code": "71610-0685-30",
      "ProductNDC": "71610-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Modafinil",
      "NonProprietaryName": "Modafinil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077667",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "MODAFINIL",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-01-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of UseIn OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.",
      "Description": "Modafinil, USP is a wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Modafinil Tablets meet USP Dissolution Test 3."
    },
    {
      "NDCCode": "71919-685-08",
      "PackageDescription": "30 mL in 1 VIAL, GLASS (71919-685-08) ",
      "NDC11Code": "71919-0685-08",
      "ProductNDC": "71919-685",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Toxicophis Pugnax",
      "NonProprietaryName": "Agkistrodon Piscivorus Venom",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110517",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "AGKISTRODON PISCIVORUS VENOM",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110517",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76282-685-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76282-685-30) ",
      "NDC11Code": "76282-0685-30",
      "ProductNDC": "76282-685",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambrisentan",
      "NonProprietaryName": "Ambrisentan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200722",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210715",
      "LabelerName": "Exelan Pharmaceuticals, Inc.",
      "SubstanceName": "AMBRISENTAN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200722",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ambrisentan tablet is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1   To improve exercise ability and delay clinical worsening.",
      "Description": "Ambrisentan is an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. The chemical name of ambrisentan is (+)-(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C22H22N2O4 and a molecular weight of 378.42. It contains a single chiral center determined to be the (S) configuration and has the following structural formula. Figure 1 Ambrisentan Structural Formula. Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each square, pale pink ambrisentan tablet contains 5 mg of ambrisentan. Each oval, deep pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored."
    },
    {
      "NDCCode": "76420-685-30",
      "PackageDescription": "1 JAR in 1 CARTON (76420-685-30)  > 30 g in 1 JAR",
      "NDC11Code": "76420-0685-30",
      "ProductNDC": "76420-685",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Testosterone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20161024",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "TESTOSTERONE",
      "StrengthNumber": ".004",
      "StrengthUnit": "g/g",
      "DEASchedule": "CIII",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-14",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "24-OCT-16"
    },
    {
      "NDCCode": "21130-001-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21130-001-10)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "21130-0001-10",
      "ProductNDC": "21130-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050711",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075217",
      "LabelerName": "Safeway",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "21130-003-30",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21130-003-30)  > 30 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "21130-0003-30",
      "ProductNDC": "21130-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acid Reducer",
      "NonProprietaryName": "Ranitidine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201745",
      "LabelerName": "SAFEWAY INC.",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages."
    },
    {
      "NDCCode": "21130-008-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21130-008-10)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "21130-0008-10",
      "ProductNDC": "21130-008",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Infants",
      "ProprietaryNameSuffix": "Concentrated Aspirin Free",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970917",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Safeway",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/.8mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    }
  ]
}
                    
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<NDCList>
  <NDC>
    <NDCCode>21130-685-30</NDCCode>
    <PackageDescription>100 PACKET in 1 BOX (21130-685-30)  / 1 APPLICATOR in 1 PACKET (21130-685-09)  / 5 mL in 1 APPLICATOR</PackageDescription>
    <NDC11Code>21130-0685-30</NDC11Code>
    <ProductNDC>21130-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Signature Care Alcohol Prep Pad</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200831</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Better Living Brands LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> first aid antiseptic to prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13537-685-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (13537-685-02)  &gt; 30 mL in 1 BOTTLE (13537-685-01)</PackageDescription>
    <NDC11Code>13537-0685-02</NDC11Code>
    <ProductNDC>13537-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName>
    <ProprietaryNameSuffix>Medium 5 - Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151123</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>.07; .0244</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13811-685-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (13811-685-30)</PackageDescription>
    <NDC11Code>13811-0685-30</NDC11Code>
    <ProductNDC>13811-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
    <NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202713</ApplicationNumber>
    <LabelerName>Trigen Laboratories, LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
    <StrengthNumber>5; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>14141-685-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (14141-685-02)  / 30 mL in 1 BOTTLE (14141-685-01) </PackageDescription>
    <NDC11Code>14141-0685-02</NDC11Code>
    <ProductNDC>14141-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName>
    <ProprietaryNameSuffix>Medium 5 - Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191202</StartMarketingDate>
    <EndMarketingDate>20240315</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Bel Star S.A. (Colombia)</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>.07; .0244</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20191202</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240315</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16571-685-03</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (16571-685-03) </PackageDescription>
    <NDC11Code>16571-0685-03</NDC11Code>
    <ProductNDC>16571-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212285</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. D&amp;C Yellow 10, FD&amp;C Red 40, FD&amp;C Blue 1 (50 mg capsules only), gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, black iron oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-685-30)</PackageDescription>
    <NDC11Code>16590-0685-30</NDC11Code>
    <ProductNDC>16590-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078858</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
    <Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.                          250 mg tablets: FD&amp;C Blue # 2 Lake of indigo carmine.                          500 mg tablets: Ferric oxide yellow.                          750 mg tablets: Ferric oxide red and FD&amp;C # 6 lake of sunset yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-685-01</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-685-01) </PackageDescription>
    <NDC11Code>16714-0685-01</NDC11Code>
    <ProductNDC>16714-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-685-30)</PackageDescription>
    <NDC11Code>33261-0685-30</NDC11Code>
    <ProductNDC>33261-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA085762</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>2.5; .025</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea.</IndicationAndUsage>
    <Description>Each tablet for oral administration contains. diphenoxylatehydrochloride, USP 2.5 mg(Warning – May be habit forming). atropinesulfate, USP 0.025 mg. Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3, 3-diphenylpropyl)-4-phenyl-isonipecotate monohydrochloride and has the following structure. Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structure. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (35356-685-30) </PackageDescription>
    <NDC11Code>35356-0685-30</NDC11Code>
    <ProductNDC>35356-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nabumetone</ProprietaryName>
    <NonProprietaryName>Nabumentone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075280</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>NABUMETONE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43063-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-685-30) </PackageDescription>
    <NDC11Code>43063-0685-30</NDC11Code>
    <ProductNDC>43063-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202991</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>7.5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43598-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43598-685-30) </PackageDescription>
    <NDC11Code>43598-0685-30</NDC11Code>
    <ProductNDC>43598-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
    <NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250506</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211238</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
    <Description>The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5Hdibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is. Eslicarbazepine acetate is a white to off-white crystalline powder. It is soluble in dichloromethane and sparingly soluble in methanol. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, hydroxyl propyl methyl cellulose, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>45865-685-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (45865-685-30)</PackageDescription>
    <NDC11Code>45865-0685-30</NDC11Code>
    <ProductNDC>45865-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110829</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078722</ApplicationNumber>
    <LabelerName>Medsource Pharmaceuticals</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK a of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride is supplied as a 5 mg, 7.5 mg and 10 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>47335-685-83</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (47335-685-83) </PackageDescription>
    <NDC11Code>47335-0685-83</NDC11Code>
    <ProductNDC>47335-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208066</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its  chemical  name  is  (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1­ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, alginic acid, pregelatinized corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and carnauba wax. The 80 mg tablets also contain yellow iron oxide, FD&amp;C Blue#1 aluminum lake and black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, DISPENSING (51655-685-30)</PackageDescription>
    <NDC11Code>51655-0685-30</NDC11Code>
    <ProductNDC>51655-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen Sodium</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritisFor the relief of the signs and symptoms of osteoarthritisFor the relief of the signs and symptoms of ankylosing spondylitisFor the relief of the signs and symptoms of juvenile arthritis. Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen as naproxen and naproxen sodium tablets are also indicated. For relief of the signs and symptoms of tendonitisFor relief of the signs and symptoms of bursitisFor relief of the signs and symptoms of acute goutFor the management of painFor the management of primary dysmenorrhea.</IndicationAndUsage>
    <Description>Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.</Description>
  </NDC>
  <NDC>
    <NDCCode>52083-685-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (52083-685-01)  &gt; 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>52083-0685-01</NDC11Code>
    <ProductNDC>52083-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Abanatuss Ped Drops</ProprietaryName>
    <NonProprietaryName>Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150805</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>KRAMER NOVIS</LabelerName>
    <SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>6.25; .5; 15</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52125-685-02</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (52125-685-02)</PackageDescription>
    <NDC11Code>52125-0685-02</NDC11Code>
    <ProductNDC>52125-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenytoin Sodium</ProprietaryName>
    <NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130827</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040684</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>PHENYTOIN SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55700-685-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-685-30) </PackageDescription>
    <NDC11Code>55700-0685-30</NDC11Code>
    <ProductNDC>55700-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180914</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078110</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59651-685-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-685-30) </PackageDescription>
    <NDC11Code>59651-0685-30</NDC11Code>
    <ProductNDC>59651-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218462</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>11</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib extended-release tablets are Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. , 2 Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. , 3 Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. .</IndicationAndUsage>
    <Description>Tofacitinib extended-release tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white crystalline powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib extended-release tablets are supplied for oral administration as a 11 mg pink, oval, bevel edged, mat finished film-coated extended-release tablets imprinted with “TI11” on one side and plain on other side. Each 11 mg tablet of tofacitinib extended-release tablet contains 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) and the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene oxide, titanium dioxide and triacetin. Printing ink contains, iron oxide black, propylene glycol, and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-685-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-685-30) </PackageDescription>
    <NDC11Code>61919-0685-30</NDC11Code>
    <ProductNDC>61919-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078154</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Partial Onset Seizures. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures. Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
    <Description>Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&amp;C Blue No. 2 Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C yellow No.6 Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>66096-685-02</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-685-02)</PackageDescription>
    <NDC11Code>66096-0685-02</NDC11Code>
    <ProductNDC>66096-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rejuvenate 2000 Pm Formula For Women</ProprietaryName>
    <NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130701</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>OHM PHARMA INC.</LabelerName>
    <SubstanceName>SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC</SubstanceName>
    <StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USES: Temporarily relieves symptoms of low energy and occasional sleeplessness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66993-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (66993-685-30) </PackageDescription>
    <NDC11Code>66993-0685-30</NDC11Code>
    <ProductNDC>66993-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120423</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202050</ApplicationNumber>
    <LabelerName>Prasco Laboratories</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120423</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
    <Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. Meets USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>68083-685-01</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (68083-685-01)  / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>68083-0685-01</NDC11Code>
    <ProductNDC>68083-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epinephrine</ProprietaryName>
    <NonProprietaryName>Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20251002</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219239</ApplicationNumber>
    <LabelerName>Gland Pharma Limited</LabelerName>
    <SubstanceName>EPINEPHRINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: 1 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.1) , 2 For emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.2) .</IndicationAndUsage>
    <Description>Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine. 10 mL Multiple Dose Vial: 10 mL multiple dose amber glass vial containing 10 mg/10 mL (1 mg/mL) epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 10 mL vial, each 1 mL of Epinephrine Injection, USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2 to 5.0. 30 mL Multiple Dose Vial. 30 mL multiple dose amber glass vial containing 30 mg/30 mL epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 30 mL vial, each 1 mL of Epinephrine Injection USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
  </NDC>
  <NDC>
    <NDCCode>69097-685-02</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (69097-685-02) </PackageDescription>
    <NDC11Code>69097-0685-02</NDC11Code>
    <ProductNDC>69097-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
    <NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212280</ApplicationNumber>
    <LabelerName>Cipla USA Inc.</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. Pregabalin capsules are indicated for.  : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg &amp; 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg &amp; 300 mg contains: FD &amp;C Blue 1, FD&amp; C Red 40, FD&amp; C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-685-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (71610-685-30) </PackageDescription>
    <NDC11Code>71610-0685-30</NDC11Code>
    <ProductNDC>71610-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Modafinil</ProprietaryName>
    <NonProprietaryName>Modafinil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077667</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>MODAFINIL</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-01-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of UseIn OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.</IndicationAndUsage>
    <Description>Modafinil, USP is a wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Modafinil Tablets meet USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-685-08</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, GLASS (71919-685-08) </PackageDescription>
    <NDC11Code>71919-0685-08</NDC11Code>
    <ProductNDC>71919-685</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Toxicophis Pugnax</ProprietaryName>
    <NonProprietaryName>Agkistrodon Piscivorus Venom</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>AGKISTRODON PISCIVORUS VENOM</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76282-685-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76282-685-30) </PackageDescription>
    <NDC11Code>76282-0685-30</NDC11Code>
    <ProductNDC>76282-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ambrisentan</ProprietaryName>
    <NonProprietaryName>Ambrisentan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200722</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210715</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMBRISENTAN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ambrisentan tablet is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1   To improve exercise ability and delay clinical worsening.</IndicationAndUsage>
    <Description>Ambrisentan is an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. The chemical name of ambrisentan is (+)-(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C22H22N2O4 and a molecular weight of 378.42. It contains a single chiral center determined to be the (S) configuration and has the following structural formula. Figure 1 Ambrisentan Structural Formula. Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&amp;C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each square, pale pink ambrisentan tablet contains 5 mg of ambrisentan. Each oval, deep pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-685-30</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (76420-685-30)  &gt; 30 g in 1 JAR</PackageDescription>
    <NDC11Code>76420-0685-30</NDC11Code>
    <ProductNDC>76420-685</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Testosterone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20161024</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>TESTOSTERONE</SubstanceName>
    <StrengthNumber>.004</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <DEASchedule>CIII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-14</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-OCT-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>21130-001-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-001-10)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0001-10</NDC11Code>
    <ProductNDC>21130-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050711</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075217</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1.25mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>21130-003-30</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-003-30)  &gt; 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0003-30</NDC11Code>
    <ProductNDC>21130-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acid Reducer</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201745</ApplicationNumber>
    <LabelerName>SAFEWAY INC.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-008-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-008-10)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0008-10</NDC11Code>
    <ProductNDC>21130-008</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Infants</ProprietaryName>
    <ProprietaryNameSuffix>Concentrated Aspirin Free</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970917</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>21130-685-30</NDCCode><ProprietaryName>Signature Care Alcohol Prep Pad</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>13537-685-02</NDCCode><ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>13811-685-30</NDCCode><ProprietaryName>Amlodipine And Valsartan</ProprietaryName><NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>14141-685-02</NDCCode><ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>16571-685-03</NDCCode><ProprietaryName>Clomipramine Hydrochloride</ProprietaryName><NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-685-30</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>16714-685-01</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>33261-685-30</NDCCode><ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName><NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35356-685-30</NDCCode><ProprietaryName>Nabumetone</ProprietaryName><NonProprietaryName>Nabumentone</NonProprietaryName></NDC><NDC><NDCCode>43063-685-30</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>43598-685-30</NDCCode><ProprietaryName>Eslicarbazepine Acetate</ProprietaryName><NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName></NDC><NDC><NDCCode>45865-685-30</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>47335-685-83</NDCCode><ProprietaryName>Lurasidone Hydrochloride</ProprietaryName><NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51655-685-30</NDCCode><ProprietaryName>Naproxen Sodium</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>52083-685-01</NDCCode><ProprietaryName>Abanatuss Ped Drops</ProprietaryName><NonProprietaryName>Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>52125-685-02</NDCCode><ProprietaryName>Phenytoin Sodium</ProprietaryName><NonProprietaryName>Phenytoin Sodium</NonProprietaryName></NDC><NDC><NDCCode>55700-685-30</NDCCode><ProprietaryName>Ropinirole Hydrochloride</ProprietaryName><NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59651-685-30</NDCCode><ProprietaryName>Tofacitinib</ProprietaryName><NonProprietaryName>Tofacitinib</NonProprietaryName></NDC><NDC><NDCCode>61919-685-30</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>66096-685-02</NDCCode><ProprietaryName>Rejuvenate 2000 Pm Formula For Women</ProprietaryName><NonProprietaryName>Rsomatotropin, Rigf-i, Rigf-ii, Rna, Dna,glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met.</NonProprietaryName></NDC><NDC><NDCCode>66993-685-30</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>68083-685-01</NDCCode><ProprietaryName>Epinephrine</ProprietaryName><NonProprietaryName>Epinephrine</NonProprietaryName></NDC><NDC><NDCCode>69097-685-02</NDCCode><ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName><NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName></NDC><NDC><NDCCode>71610-685-30</NDCCode><ProprietaryName>Modafinil</ProprietaryName><NonProprietaryName>Modafinil</NonProprietaryName></NDC><NDC><NDCCode>71919-685-08</NDCCode><ProprietaryName>Toxicophis Pugnax</ProprietaryName><NonProprietaryName>Agkistrodon Piscivorus Venom</NonProprietaryName></NDC><NDC><NDCCode>76282-685-30</NDCCode><ProprietaryName>Ambrisentan</ProprietaryName><NonProprietaryName>Ambrisentan</NonProprietaryName></NDC><NDC><NDCCode>76420-685-30</NDCCode><NonProprietaryName>Testosterone</NonProprietaryName></NDC><NDC><NDCCode>21130-001-10</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>21130-003-30</NDCCode><ProprietaryName>Acid Reducer</ProprietaryName><NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>21130-008-10</NDCCode><ProprietaryName>Infants</ProprietaryName><NonProprietaryName>Acetaminophen</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",
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    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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}
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