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How to Find 10893-083-12 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "10893-083-12",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (10893-083-12)  > 1 CREAM in 1 BOTTLE, GLASS",
      "NDC11Code": "10893-0083-12",
      "ProductNDC": "10893-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naturasil",
      "ProprietaryNameSuffix": "Scabies",
      "NonProprietaryName": "Sulfur",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111001",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Nature's Innovation, Inc.",
      "SubstanceName": "SULFUR",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "12634-083-52",
      "PackageDescription": "12 TABLET, FILM COATED in 1 BLISTER PACK (12634-083-52)",
      "NDC11Code": "12634-0083-52",
      "ProductNDC": "12634-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090278",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1) , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (  1.2)  .",
      "Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate  tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-­Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
    },
    {
      "NDCCode": "12634-083-82",
      "PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (12634-083-82)",
      "NDC11Code": "12634-0083-82",
      "ProductNDC": "12634-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090278",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1) , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (  1.2)  .",
      "Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate  tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-­Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
    },
    {
      "NDCCode": "16714-083-12",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (16714-083-12)",
      "NDC11Code": "16714-0083-12",
      "ProductNDC": "16714-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Hydrochloride",
      "NonProprietaryName": "Hydroxyzine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040840",
      "LabelerName": "Northstar RxLLC",
      "SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "24236-083-07",
      "PackageDescription": "12 CAPSULE in 1 VIAL (24236-083-07)",
      "NDC11Code": "24236-0083-07",
      "ProductNDC": "24236-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130521",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "24236-083-12",
      "PackageDescription": "8 CAPSULE in 1 VIAL (24236-083-12)",
      "NDC11Code": "24236-0083-12",
      "ProductNDC": "24236-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130523",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "33342-083-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-083-12)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "33342-0083-12",
      "ProductNDC": "33342-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine",
      "NonProprietaryName": "Olanzapine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203044",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "OLANZAPINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150227",
      "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 13-17): 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 13-17): 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 USP 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 orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2."
    },
    {
      "NDCCode": "42851-083-12",
      "PackageDescription": "1 TUBE in 1 CARTON (42851-083-12)  > 113 mL in 1 TUBE",
      "NDC11Code": "42851-0083-12",
      "ProductNDC": "42851-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Revitatrol Epidermal Repair Skin Protectant",
      "NonProprietaryName": "Oatmeal",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "ZO Skin Health, Inc.",
      "SubstanceName": "OATMEAL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to: 1 rashes."
    },
    {
      "NDCCode": "61715-083-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (61715-083-24)  > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "61715-0083-24",
      "ProductNDC": "61715-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131125",
      "EndMarketingDate": "20201125",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part336",
      "LabelerName": "Preferred Plus (Kinray)",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20131125",
      "EndMarketingDatePackage": "20201125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61715-083-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (61715-083-48)  > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "61715-0083-48",
      "ProductNDC": "61715-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131125",
      "EndMarketingDate": "20201125",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part336",
      "LabelerName": "Preferred Plus (Kinray)",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20131125",
      "EndMarketingDatePackage": "20201125",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64896-083-12",
      "PackageDescription": "6 BOTTLE, SPRAY in 1 CARTON (64896-083-12)  / 1 SPRAY, METERED in 1 BOTTLE, SPRAY",
      "NDC11Code": "64896-0083-12",
      "ProductNDC": "64896-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zomig",
      "NonProprietaryName": "Zolmitriptan",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20240715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021450",
      "LabelerName": "Amneal Pharmaceuticals LLC",
      "SubstanceName": "ZOLMITRIPTAN",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240715",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks., 2 ZOMIG is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of ZOMIG have not been established for cluster headache., 4 Not recommended in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.2)].",
      "Description": "ZOMIG® (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino) ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. ZOMIG Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray contains 2.5 mg or 5 mg of zolmitriptan in a 100-μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP. ZOMIG Nasal Spray is hypertonic. The osmolarity of ZOMIG Nasal Spray for 2.5 mg is 360 to 420 mOsmol, and for 5 mg is 420 to 470 mOsmol."
    },
    {
      "NDCCode": "72673-083-12",
      "PackageDescription": "1 BOTTLE in 1 CARTON (72673-083-12)  / 30 mL in 1 BOTTLE",
      "NDC11Code": "72673-0083-12",
      "ProductNDC": "72673-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azithromycin",
      "NonProprietaryName": "Azithromycin",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217036",
      "LabelerName": "Zhejiang Poly Pharm. Co., Ltd.",
      "SubstanceName": "AZITHROMYCIN DIHYDRATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
      "Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "73212-083-12",
      "PackageDescription": "100 g in 1 BOTTLE (73212-083-12) ",
      "NDC11Code": "73212-0083-12",
      "ProductNDC": "73212-083",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Afamelanotide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20231101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Qingdao Biopeptek Co., Ltd.",
      "SubstanceName": "AFAMELANOTIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-12",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-NOV-23"
    },
    {
      "NDCCode": "79903-083-01",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (79903-083-01)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "79903-0083-01",
      "ProductNDC": "79903-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nighttime Sleep Aid",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210622",
      "EndMarketingDate": "20280731",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M010",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210622",
      "EndMarketingDatePackage": "20280331",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
    },
    {
      "NDCCode": "79903-083-02",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (79903-083-02)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "79903-0083-02",
      "ProductNDC": "79903-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nighttime Sleep Aid",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210622",
      "EndMarketingDate": "20280731",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M010",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210622",
      "EndMarketingDatePackage": "20280731",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
    },
    {
      "NDCCode": "0404-9807-10",
      "PackageDescription": "1 SYRINGE, GLASS in 1 BAG (0404-9807-10)  / 10 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "00404-9807-10",
      "ProductNDC": "0404-9807",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atropine Sulfate",
      "NonProprietaryName": "Atropine Sulfate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20241119",
      "EndMarketingDate": "20251130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215342",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "ATROPINE SULFATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20241119",
      "EndMarketingDatePackage": "20251130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning and to treat bradyasystolic cardiac arrest.",
      "Description": "Atropine sulfate injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine sulfate, USP is chemically designated 1α H, 5α H-tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 H2SO4H2O, colorless, almost white to white solid. It is very soluble in water and glacial acetic acid, freely soluble in ethanol (96%) and practically insoluble in diethyl ether. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water."
    },
    {
      "NDCCode": "11527-083-54",
      "PackageDescription": "1 TUBE in 1 CARTON (11527-083-54)  > 28 g in 1 TUBE",
      "NDC11Code": "11527-0083-54",
      "ProductNDC": "11527-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr. Sheffield Vapor Cream",
      "NonProprietaryName": "Vapor Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Sheffield Pharmaceuticals LLC",
      "SubstanceName": "CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL",
      "StrengthNumber": "52; 12; 28",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-22",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231"
    },
    {
      "NDCCode": "11722-083-00",
      "PackageDescription": "1 kg in 1 CARTON (11722-083-00) ",
      "NDC11Code": "11722-0083-00",
      "ProductNDC": "11722-083",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Zavegepant",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20241216",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "TAPI Croatia Industries Ltd.",
      "SubstanceName": "ZAVEGEPANT HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-12-19",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "16-DEC-24"
    },
    {
      "NDCCode": "13107-083-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13107-083-01) ",
      "NDC11Code": "13107-0083-01",
      "ProductNDC": "13107-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lorazepam",
      "NonProprietaryName": "Lorazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203572",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "LORAZEPAM",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
      "Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
    },
    {
      "NDCCode": "13107-083-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (13107-083-05) ",
      "NDC11Code": "13107-0083-05",
      "ProductNDC": "13107-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lorazepam",
      "NonProprietaryName": "Lorazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203572",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "LORAZEPAM",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
      "Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
    },
    {
      "NDCCode": "13107-083-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE (13107-083-10) ",
      "NDC11Code": "13107-0083-10",
      "ProductNDC": "13107-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lorazepam",
      "NonProprietaryName": "Lorazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203572",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "LORAZEPAM",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
      "Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
    },
    {
      "NDCCode": "13107-083-99",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (13107-083-99) ",
      "NDC11Code": "13107-0083-99",
      "ProductNDC": "13107-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lorazepam",
      "NonProprietaryName": "Lorazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203572",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "LORAZEPAM",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.",
      "Description": "Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
    },
    {
      "NDCCode": "21130-083-58",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (21130-083-58)  > 10 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "21130-0083-58",
      "ProductNDC": "21130-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold And Sinus Pain Relief",
      "NonProprietaryName": "Ibuprofen, Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20011030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074567",
      "LabelerName": "Safeway",
      "SubstanceName": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "200; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "21130-083-60",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (21130-083-60)  > 10 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "21130-0083-60",
      "ProductNDC": "21130-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold And Sinus Pain Relief",
      "NonProprietaryName": "Ibuprofen, Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20011030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074567",
      "LabelerName": "Safeway",
      "SubstanceName": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "200; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "21695-083-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-083-30)",
      "NDC11Code": "21695-0083-30",
      "ProductNDC": "21695-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mirtazapine",
      "NonProprietaryName": "Mirtazapine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20041022",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076921",
      "LabelerName": "Rebel Distributors Corp.",
      "SubstanceName": "MIRTAZAPINE",
      "StrengthNumber": "45",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).",
      "Description": "Mirtazapine tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine. Each tablet also contains corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose monohydrate, hypromellose and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black and iron oxide yellow."
    },
    {
      "NDCCode": "24236-083-04",
      "PackageDescription": "14 CAPSULE in 1 BLISTER PACK (24236-083-04)",
      "NDC11Code": "24236-0083-04",
      "ProductNDC": "24236-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "24236-083-08",
      "PackageDescription": "10 CAPSULE in 1 BLISTER PACK (24236-083-08)",
      "NDC11Code": "24236-0083-08",
      "ProductNDC": "24236-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120821",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "24236-083-10",
      "PackageDescription": "6 CAPSULE in 1 BOTTLE (24236-083-10)",
      "NDC11Code": "24236-0083-10",
      "ProductNDC": "24236-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "24236-083-15",
      "PackageDescription": "15 CAPSULE in 1 BLISTER PACK (24236-083-15)",
      "NDC11Code": "24236-0083-15",
      "ProductNDC": "24236-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "24236-083-57",
      "PackageDescription": "5 CAPSULE in 1 BOTTLE (24236-083-57)",
      "NDC11Code": "24236-0083-57",
      "ProductNDC": "24236-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loperamide Hydrochloride",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073192",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    }
  ]
}
                    
{"NDC":[{"NDCCode":"10893-083-12","ProprietaryName":"Naturasil","NonProprietaryName":"Sulfur"},{"NDCCode":"12634-083-52","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"},{"NDCCode":"12634-083-82","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"},{"NDCCode":"16714-083-12","ProprietaryName":"Hydroxyzine Hydrochloride","NonProprietaryName":"Hydroxyzine Hydrochloride"},{"NDCCode":"24236-083-07","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"24236-083-12","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"33342-083-12","ProprietaryName":"Olanzapine","NonProprietaryName":"Olanzapine"},{"NDCCode":"42851-083-12","ProprietaryName":"Revitatrol Epidermal Repair Skin Protectant","NonProprietaryName":"Oatmeal"},{"NDCCode":"61715-083-24","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"61715-083-48","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"64896-083-12","ProprietaryName":"Zomig","NonProprietaryName":"Zolmitriptan"},{"NDCCode":"72673-083-12","ProprietaryName":"Azithromycin","NonProprietaryName":"Azithromycin"},{"NDCCode":"73212-083-12","NonProprietaryName":"Afamelanotide"},{"NDCCode":"79903-083-01","ProprietaryName":"Nighttime Sleep Aid","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"79903-083-02","ProprietaryName":"Nighttime Sleep Aid","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"0404-9807-10","ProprietaryName":"Atropine Sulfate","NonProprietaryName":"Atropine Sulfate"},{"NDCCode":"11527-083-54","ProprietaryName":"Dr. Sheffield Vapor Cream","NonProprietaryName":"Vapor Cream"},{"NDCCode":"11722-083-00","NonProprietaryName":"Zavegepant"},{"NDCCode":"13107-083-01","ProprietaryName":"Lorazepam","NonProprietaryName":"Lorazepam"},{"NDCCode":"13107-083-05","ProprietaryName":"Lorazepam","NonProprietaryName":"Lorazepam"},{"NDCCode":"13107-083-10","ProprietaryName":"Lorazepam","NonProprietaryName":"Lorazepam"},{"NDCCode":"13107-083-99","ProprietaryName":"Lorazepam","NonProprietaryName":"Lorazepam"},{"NDCCode":"21130-083-58","ProprietaryName":"Cold And Sinus Pain Relief","NonProprietaryName":"Ibuprofen, Pseudoephedrine Hydrochloride"},{"NDCCode":"21130-083-60","ProprietaryName":"Cold And Sinus Pain Relief","NonProprietaryName":"Ibuprofen, Pseudoephedrine Hydrochloride"},{"NDCCode":"21695-083-30","ProprietaryName":"Mirtazapine","NonProprietaryName":"Mirtazapine"},{"NDCCode":"24236-083-04","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"24236-083-08","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"24236-083-10","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"24236-083-15","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"},{"NDCCode":"24236-083-57","ProprietaryName":"Loperamide Hydrochloride","NonProprietaryName":"Loperamide Hydrochloride"}]}
                    
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<NDCList>
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    <NDCCode>10893-083-12</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (10893-083-12)  &gt; 1 CREAM in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>10893-0083-12</NDC11Code>
    <ProductNDC>10893-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naturasil</ProprietaryName>
    <ProprietaryNameSuffix>Scabies</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfur</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nature's Innovation, Inc.</LabelerName>
    <SubstanceName>SULFUR</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>12634-083-52</NDCCode>
    <PackageDescription>12 TABLET, FILM COATED in 1 BLISTER PACK (12634-083-52)</PackageDescription>
    <NDC11Code>12634-0083-52</NDC11Code>
    <ProductNDC>12634-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090278</ApplicationNumber>
    <LabelerName>Apotheca Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1) , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (  1.2)  .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate  tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-­Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&amp;C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>12634-083-82</NDCCode>
    <PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (12634-083-82)</PackageDescription>
    <NDC11Code>12634-0083-82</NDC11Code>
    <ProductNDC>12634-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090278</ApplicationNumber>
    <LabelerName>Apotheca Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1) , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (  1.2)  .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate  tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-­Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain:. 50 mg tablets: iron oxide yellow. 100 mg tablets: iron oxide yellow, and D&amp;C Yellow # 10 Aluminum Lake. 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-083-12</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (16714-083-12)</PackageDescription>
    <NDC11Code>16714-0083-12</NDC11Code>
    <ProductNDC>16714-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040840</ApplicationNumber>
    <LabelerName>Northstar RxLLC</LabelerName>
    <SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>24236-083-07</NDCCode>
    <PackageDescription>12 CAPSULE in 1 VIAL (24236-083-07)</PackageDescription>
    <NDC11Code>24236-0083-07</NDC11Code>
    <ProductNDC>24236-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130521</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>24236-083-12</NDCCode>
    <PackageDescription>8 CAPSULE in 1 VIAL (24236-083-12)</PackageDescription>
    <NDC11Code>24236-0083-12</NDC11Code>
    <ProductNDC>24236-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>33342-083-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-083-12)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0083-12</NDC11Code>
    <ProductNDC>33342-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
    <NonProprietaryName>Olanzapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203044</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150227</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 13-17): 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 13-17): 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 USP 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 orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>42851-083-12</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (42851-083-12)  &gt; 113 mL in 1 TUBE</PackageDescription>
    <NDC11Code>42851-0083-12</NDC11Code>
    <ProductNDC>42851-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Revitatrol Epidermal Repair Skin Protectant</ProprietaryName>
    <NonProprietaryName>Oatmeal</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <SubstanceName>OATMEAL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Temporarily protects and helps relieve minor skin irritation and itching due to: 1 rashes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61715-083-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (61715-083-24)  &gt; 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>61715-0083-24</NDC11Code>
    <ProductNDC>61715-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131125</StartMarketingDate>
    <EndMarketingDate>20201125</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part336</ApplicationNumber>
    <LabelerName>Preferred Plus (Kinray)</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201125</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61715-083-48</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (61715-083-48)  &gt; 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>61715-0083-48</NDC11Code>
    <ProductNDC>61715-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131125</StartMarketingDate>
    <EndMarketingDate>20201125</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part336</ApplicationNumber>
    <LabelerName>Preferred Plus (Kinray)</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201125</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>64896-083-12</NDCCode>
    <PackageDescription>6 BOTTLE, SPRAY in 1 CARTON (64896-083-12)  / 1 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>64896-0083-12</NDC11Code>
    <ProductNDC>64896-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zomig</ProprietaryName>
    <NonProprietaryName>Zolmitriptan</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20240715</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021450</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ZOLMITRIPTAN</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks., 2 ZOMIG is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of ZOMIG have not been established for cluster headache., 4 Not recommended in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.2)].</IndicationAndUsage>
    <Description>ZOMIG® (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino) ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. ZOMIG Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray contains 2.5 mg or 5 mg of zolmitriptan in a 100-μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP. ZOMIG Nasal Spray is hypertonic. The osmolarity of ZOMIG Nasal Spray for 2.5 mg is 360 to 420 mOsmol, and for 5 mg is 420 to 470 mOsmol.</Description>
  </NDC>
  <NDC>
    <NDCCode>72673-083-12</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (72673-083-12)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>72673-0083-12</NDC11Code>
    <ProductNDC>72673-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217036</ApplicationNumber>
    <LabelerName>Zhejiang Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>73212-083-12</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE (73212-083-12) </PackageDescription>
    <NDC11Code>73212-0083-12</NDC11Code>
    <ProductNDC>73212-083</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Afamelanotide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
    <SubstanceName>AFAMELANOTIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-12</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-NOV-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>79903-083-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (79903-083-01)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>79903-0083-01</NDC11Code>
    <ProductNDC>79903-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210622</StartMarketingDate>
    <EndMarketingDate>20280731</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M010</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210622</StartMarketingDatePackage>
    <EndMarketingDatePackage>20280331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79903-083-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (79903-083-02)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>79903-0083-02</NDC11Code>
    <ProductNDC>79903-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210622</StartMarketingDate>
    <EndMarketingDate>20280731</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M010</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210622</StartMarketingDatePackage>
    <EndMarketingDatePackage>20280731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0404-9807-10</NDCCode>
    <PackageDescription>1 SYRINGE, GLASS in 1 BAG (0404-9807-10)  / 10 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>00404-9807-10</NDC11Code>
    <ProductNDC>0404-9807</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine Sulfate</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20241119</StartMarketingDate>
    <EndMarketingDate>20251130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215342</ApplicationNumber>
    <LabelerName>Henry Schein, Inc.</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241119</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
    <Description>Atropine sulfate injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine sulfate, USP is chemically designated 1α H, 5α H-tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 H2SO4H2O, colorless, almost white to white solid. It is very soluble in water and glacial acetic acid, freely soluble in ethanol (96%) and practically insoluble in diethyl ether. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>11527-083-54</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11527-083-54)  &gt; 28 g in 1 TUBE</PackageDescription>
    <NDC11Code>11527-0083-54</NDC11Code>
    <ProductNDC>11527-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr. Sheffield Vapor Cream</ProprietaryName>
    <NonProprietaryName>Vapor Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Sheffield Pharmaceuticals LLC</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL</SubstanceName>
    <StrengthNumber>52; 12; 28</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11722-083-00</NDCCode>
    <PackageDescription>1 kg in 1 CARTON (11722-083-00) </PackageDescription>
    <NDC11Code>11722-0083-00</NDC11Code>
    <ProductNDC>11722-083</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Zavegepant</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20241216</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>TAPI Croatia Industries Ltd.</LabelerName>
    <SubstanceName>ZAVEGEPANT HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-DEC-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>13107-083-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13107-083-01) </PackageDescription>
    <NDC11Code>13107-0083-01</NDC11Code>
    <ProductNDC>13107-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203572</ApplicationNumber>
    <LabelerName>Aurolife Pharma LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
    <Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>13107-083-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13107-083-05) </PackageDescription>
    <NDC11Code>13107-0083-05</NDC11Code>
    <ProductNDC>13107-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203572</ApplicationNumber>
    <LabelerName>Aurolife Pharma LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
    <Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>13107-083-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (13107-083-10) </PackageDescription>
    <NDC11Code>13107-0083-10</NDC11Code>
    <ProductNDC>13107-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203572</ApplicationNumber>
    <LabelerName>Aurolife Pharma LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
    <Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>13107-083-99</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (13107-083-99) </PackageDescription>
    <NDC11Code>13107-0083-99</NDC11Code>
    <ProductNDC>13107-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203572</ApplicationNumber>
    <LabelerName>Aurolife Pharma LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.</IndicationAndUsage>
    <Description>Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-(o-chlorophenyl)-1,3­-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-083-58</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (21130-083-58)  &gt; 10 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0083-58</NDC11Code>
    <ProductNDC>21130-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold And Sinus Pain Relief</ProprietaryName>
    <NonProprietaryName>Ibuprofen, Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, SUGAR COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20011030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074567</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>21130-083-60</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (21130-083-60)  &gt; 10 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0083-60</NDC11Code>
    <ProductNDC>21130-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold And Sinus Pain Relief</ProprietaryName>
    <NonProprietaryName>Ibuprofen, Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, SUGAR COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20011030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074567</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200; 30</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>21695-083-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-083-30)</PackageDescription>
    <NDC11Code>21695-0083-30</NDC11Code>
    <ProductNDC>21695-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mirtazapine</ProprietaryName>
    <NonProprietaryName>Mirtazapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20041022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076921</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>MIRTAZAPINE</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).</IndicationAndUsage>
    <Description>Mirtazapine tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine. Each tablet also contains corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose monohydrate, hypromellose and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>24236-083-04</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BLISTER PACK (24236-083-04)</PackageDescription>
    <NDC11Code>24236-0083-04</NDC11Code>
    <ProductNDC>24236-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>24236-083-08</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BLISTER PACK (24236-083-08)</PackageDescription>
    <NDC11Code>24236-0083-08</NDC11Code>
    <ProductNDC>24236-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120821</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>24236-083-10</NDCCode>
    <PackageDescription>6 CAPSULE in 1 BOTTLE (24236-083-10)</PackageDescription>
    <NDC11Code>24236-0083-10</NDC11Code>
    <ProductNDC>24236-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>24236-083-15</NDCCode>
    <PackageDescription>15 CAPSULE in 1 BLISTER PACK (24236-083-15)</PackageDescription>
    <NDC11Code>24236-0083-15</NDC11Code>
    <ProductNDC>24236-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>24236-083-57</NDCCode>
    <PackageDescription>5 CAPSULE in 1 BOTTLE (24236-083-57)</PackageDescription>
    <NDC11Code>24236-0083-57</NDC11Code>
    <ProductNDC>24236-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA073192</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>10893-083-12</NDCCode><ProprietaryName>Naturasil</ProprietaryName><NonProprietaryName>Sulfur</NonProprietaryName></NDC><NDC><NDCCode>12634-083-52</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>12634-083-82</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>16714-083-12</NDCCode><ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName><NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24236-083-07</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24236-083-12</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33342-083-12</NDCCode><ProprietaryName>Olanzapine</ProprietaryName><NonProprietaryName>Olanzapine</NonProprietaryName></NDC><NDC><NDCCode>42851-083-12</NDCCode><ProprietaryName>Revitatrol Epidermal Repair Skin Protectant</ProprietaryName><NonProprietaryName>Oatmeal</NonProprietaryName></NDC><NDC><NDCCode>61715-083-24</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>61715-083-48</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>64896-083-12</NDCCode><ProprietaryName>Zomig</ProprietaryName><NonProprietaryName>Zolmitriptan</NonProprietaryName></NDC><NDC><NDCCode>72673-083-12</NDCCode><ProprietaryName>Azithromycin</ProprietaryName><NonProprietaryName>Azithromycin</NonProprietaryName></NDC><NDC><NDCCode>73212-083-12</NDCCode><NonProprietaryName>Afamelanotide</NonProprietaryName></NDC><NDC><NDCCode>79903-083-01</NDCCode><ProprietaryName>Nighttime Sleep Aid</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>79903-083-02</NDCCode><ProprietaryName>Nighttime Sleep Aid</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0404-9807-10</NDCCode><ProprietaryName>Atropine Sulfate</ProprietaryName><NonProprietaryName>Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>11527-083-54</NDCCode><ProprietaryName>Dr. Sheffield Vapor Cream</ProprietaryName><NonProprietaryName>Vapor Cream</NonProprietaryName></NDC><NDC><NDCCode>11722-083-00</NDCCode><NonProprietaryName>Zavegepant</NonProprietaryName></NDC><NDC><NDCCode>13107-083-01</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>13107-083-05</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>13107-083-10</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>13107-083-99</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>21130-083-58</NDCCode><ProprietaryName>Cold And Sinus Pain Relief</ProprietaryName><NonProprietaryName>Ibuprofen, Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>21130-083-60</NDCCode><ProprietaryName>Cold And Sinus Pain Relief</ProprietaryName><NonProprietaryName>Ibuprofen, Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>21695-083-30</NDCCode><ProprietaryName>Mirtazapine</ProprietaryName><NonProprietaryName>Mirtazapine</NonProprietaryName></NDC><NDC><NDCCode>24236-083-04</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24236-083-08</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24236-083-10</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24236-083-15</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24236-083-57</NDCCode><ProprietaryName>Loperamide Hydrochloride</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
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      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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