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How to Find 59088-233-05 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "59088-233-05",
      "PackageDescription": "57 g in 1 TUBE (59088-233-05) ",
      "NDC11Code": "59088-0233-05",
      "ProductNDC": "59088-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bruselix Gel",
      "NonProprietaryName": "Lidocaine Hci 3.88%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240321",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "38.8",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240321",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain.",
      "Description": "Bruselix Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxyethylcellulose, PEG-4, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:."
    },
    {
      "NDCCode": "12714-233-05",
      "PackageDescription": "5 mg in 1 TANK (12714-233-05) ",
      "NDC11Code": "12714-0233-05",
      "ProductNDC": "12714-233",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tenecteplase",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20000602",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
      "SubstanceName": "TENECTEPLASE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mg",
      "Status": "Unfinished",
      "LastUpdate": "2024-05-23",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "02-JUN-00"
    },
    {
      "NDCCode": "23155-233-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (23155-233-05) ",
      "NDC11Code": "23155-0233-05",
      "ProductNDC": "23155-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glyburide-metformin Hydrochloride",
      "NonProprietaryName": "Glyburide-metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079009",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1.25; 250",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glyburide and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Glyburide and metformin hydrochloride tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetis, glyburide USP and metformin hydrochloride USP. Glyburide, USP is an oral antihyperglycemia sulfonylurea class. The chemical name for glyburide USP is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound with a molecular formula of C23H28ClN3O5S and a molecular weight of 494.01. Micronised glyburide is used in glyburide and metformin hydrochloride tablets, USP. The structural formula is represented below. Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) Is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C4H12CIN5 (monohydrochloride) and a molecular weight of 165.63. Metformin is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin is 6.68. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available for oral administration in tablets containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Povidone, Colloidal Silicon Dioxide, Magnesium Stearate. The tablets are film coated, which provides color differentiation. Additionally 1.25 mg/250 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol and Iron Oxide Yellow. The 2.5 mg/500 mg tablet contains Opadry Pink which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and Iron Oxide Red. The 5 mg/500 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and D & C Yellow #10 Aluminium Lake."
    },
    {
      "NDCCode": "42571-233-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (42571-233-05) ",
      "NDC11Code": "42571-0233-05",
      "ProductNDC": "42571-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin",
      "NonProprietaryName": "Amoxicillin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207471",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "AMOXICILLIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-10-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).",
      "Description": "Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane­2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide."
    },
    {
      "NDCCode": "50228-233-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (50228-233-05) ",
      "NDC11Code": "50228-0233-05",
      "ProductNDC": "50228-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoclopramide",
      "NonProprietaryName": "Metoclopramide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072215",
      "LabelerName": "ScieGen Pharmaceuticals, Inc.",
      "SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoclopramide tablets are indicated for the: : 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1) , 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1) .",
      "Description": "Metoclopramide hydrochloride, the active ingredient of metoclopramide tablets, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. The molecular formula is C 14H 22ClN 3O 2HClH 2O. Its molecular weight is 354.3. The structural formula is:. Metoclopramide tablets are for oral administration. Metoclopramide tablets are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide 5 mg tablet contains 5 mg metoclopramide (equivalent to 5.909 mg of metoclopramide hydrochloride USP). Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate and magnesium stearate., 2 Each metoclopramide 10 mg tablet contains 10 mg metoclopramide (equivalent to 11.818 mg metoclopramide hydrochloride USP). Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate and magnesium stearate."
    },
    {
      "NDCCode": "50383-233-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (50383-233-05)  > 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "50383-0233-05",
      "ProductNDC": "50383-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
      "NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20081028",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077847",
      "LabelerName": "Hi-Tech Pharmacal Co., Inc.",
      "SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
      "StrengthNumber": "20; 5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20091028",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "57237-233-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (57237-233-05) ",
      "NDC11Code": "57237-0233-05",
      "ProductNDC": "57237-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100216",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
      "Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
    },
    {
      "NDCCode": "59651-233-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (59651-233-05) ",
      "NDC11Code": "59651-0233-05",
      "ProductNDC": "59651-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210602",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070886",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210602",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, in addition 0.1 mg and 0.2 mg contains D&C Yellow No. 10, 0.1 mg and 0.3 mg contains FD&C Blue No. 1, and 0.3 mg contains FD&C Blue No. 2.  Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white or almost white crystalline powder. Soluble in water and ethanol, slightly soluble in chloroform."
    },
    {
      "NDCCode": "59746-233-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59746-233-05)",
      "NDC11Code": "59746-0233-05",
      "ProductNDC": "59746-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxcarbazepine",
      "NonProprietaryName": "Oxcarbazepine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100214",
      "EndMarketingDate": "20150630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090239",
      "LabelerName": "JUBILANT CADISTA PHARMACEUTICALS, INC.",
      "SubstanceName": "OXCARBAZEPINE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-03"
    },
    {
      "NDCCode": "64922-233-05",
      "PackageDescription": "1698 L in 1 CYLINDER (64922-233-05) ",
      "NDC11Code": "64922-0233-05",
      "ProductNDC": "64922-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19900101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205767",
      "LabelerName": "ADF Welding & Medical, Inc.",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "99",
      "StrengthUnit": "L/100L",
      "Status": "Active",
      "LastUpdate": "2024-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19900101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-233-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-233-05) ",
      "NDC11Code": "68428-0233-05",
      "ProductNDC": "68428-233",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Asclepias Tuberosa",
      "NonProprietaryName": "Asclepias Tuberosa Root",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "ASCLEPIAS TUBEROSA ROOT",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69367-233-05",
      "PackageDescription": "5 mL in 1 BOTTLE, DROPPER (69367-233-05) ",
      "NDC11Code": "69367-0233-05",
      "ProductNDC": "69367-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olopatadine Hydrochloride",
      "NonProprietaryName": "Olopatadine Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20190919",
      "EndMarketingDate": "20220502",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203152",
      "LabelerName": "Westminster Pharmaceuticals, LLC",
      "SubstanceName": "OLOPATADINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190919",
      "EndMarketingDatePackage": "20220502",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70010-233-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (70010-233-05) ",
      "NDC11Code": "70010-0233-05",
      "ProductNDC": "70010-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trazodone Hydrochloride",
      "NonProprietaryName": "Trazodone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240809",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218988",
      "LabelerName": "Granules Pharmaceuticals Inc.",
      "SubstanceName": "TRAZODONE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240809",
      "SamplePackage": "N",
      "IndicationAndUsage": "Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, USP, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 1,2,4-Triazolo[4,3-a]pyridin-3(2H)-one, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-, monohydrochloride. It is a white to off white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows. Molecular Formula: C 19H 22CIN 5O  HCl Molecular Weight: 408.32. Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinised starch, sodium lauryl sulphate, sodium starch glycolate type A. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "71052-233-05",
      "PackageDescription": "500 g in 1 CONTAINER (71052-233-05) ",
      "NDC11Code": "71052-0233-05",
      "ProductNDC": "71052-233",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Azithromycin Dihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200420",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "DARMERICA, LLC",
      "SubstanceName": "AZITHROMYCIN DIHYDRATE",
      "StrengthNumber": "1000",
      "StrengthUnit": "g/1000g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "12-JAN-22"
    },
    {
      "NDCCode": "72865-233-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (72865-233-05) ",
      "NDC11Code": "72865-0233-05",
      "ProductNDC": "72865-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methocarbamol",
      "NonProprietaryName": "Methocarbamol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090200",
      "LabelerName": "XLCare Pharmaceuticals Inc.",
      "SubstanceName": "METHOCARBAMOL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methocarbamol tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
      "Description": "Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid."
    },
    {
      "NDCCode": "76420-233-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (76420-233-05) ",
      "NDC11Code": "76420-0233-05",
      "ProductNDC": "76420-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zolpidem Tartrate",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077903",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-02-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.",
      "Description": "Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow."
    },
    {
      "NDCCode": "59088-215-05",
      "PackageDescription": "59 mL in 1 JAR (59088-215-05) ",
      "NDC11Code": "59088-0215-05",
      "ProductNDC": "59088-215",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mencylate",
      "ProprietaryNameSuffix": "Pain Relieving",
      "NonProprietaryName": "Menthol, Methyl Salicylate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230324",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "METHYL SALICYLATE; MENTHOL",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230324",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with  simple backache  arthritis  strains  bruises  sprains."
    },
    {
      "NDCCode": "59088-227-05",
      "PackageDescription": "57 g in 1 JAR (59088-227-05) ",
      "NDC11Code": "59088-0227-05",
      "ProductNDC": "59088-227",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Salycim",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231206",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PURETEK CORPORATION",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2024-05-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231206",
      "SamplePackage": "N",
      "IndicationAndUsage": "For Dermatologic Use: Salycim Cream is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use: Salycim Cream is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.",
      "Description": "Salycim Cream contains 6% salicylic acid USP in a vehicle consisting of Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Butyrospermum Parkii (Shea) Butter, Carbomer, Cetyl Alcohol, GenRx Complex® (proprietary blend), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Helianthus Annuus (Hybrid Sunflower) Seed Oil, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Hydroxide, Squalane, Stearic Acid."
    },
    {
      "NDCCode": "59088-234-05",
      "PackageDescription": "57 g in 1 TUBE (59088-234-05) ",
      "NDC11Code": "59088-0234-05",
      "ProductNDC": "59088-234",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bruselix Cream",
      "NonProprietaryName": "Lidocaine Hci 3.88%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "38.8",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain.",
      "Description": "Bruselix Cream contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Arnica Montana Flower Extract, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Phosphate, Mineral Oil. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:."
    },
    {
      "NDCCode": "59088-351-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-351-00)  *  5 g in 1 TUBE (0168-0357-05)  *  1 VIAL, MULTI-DOSE in 1 CARTON (0003-0293-05)  > 1 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "59088-0351-00",
      "ProductNDC": "59088-351",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermacinrx Cinlone-i Cpi",
      "NonProprietaryName": "Lidocaine And Prilocaine, Triamcinolone Acetonide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076453",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-25",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "59088-352-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-352-00)  *  5 g in 1 TUBE (0168-0357-05)  *  1 VIAL, MULTI-DOSE in 1 CARTON (0003-0293-05)  > 1 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "59088-0352-00",
      "ProductNDC": "59088-352",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermacinrx Cinlone-ii Cpi",
      "NonProprietaryName": "Lidocaine And Prilocaine, Triamcinolone Acetonide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160624",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076453",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2019-05-17",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "59088-378-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-378-00)  *  5 g in 1 TUBE (0168-0357-05)  *  1  in 1 BAG (GS1:19555240400625)",
      "NDC11Code": "59088-0378-00",
      "ProductNDC": "59088-378",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venipuncture Cpi",
      "NonProprietaryName": "Lidocaine And Prilocaine",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160509",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076453",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2019-05-31",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "59088-383-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-383-00)  *  1000 mL in 1 CONTAINER (0264-7800-00)  *  .8 mL in 1 PACKET (10819-3883-1)  *  5 g in 1 TUBE (0168-0357-05)",
      "NDC11Code": "59088-0383-00",
      "ProductNDC": "59088-383",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Iv Infusion Cpi",
      "NonProprietaryName": "Lidocaine And Prilocaine, Sodium Chloride, Povidone-iodine",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076453",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "59088-430-05",
      "PackageDescription": "85 g in 1 TUBE (59088-430-05) ",
      "NDC11Code": "59088-0430-05",
      "ProductNDC": "59088-430",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocort",
      "NonProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
      "DosageFormName": "CREAM",
      "RouteName": "RECTAL; TOPICAL",
      "StartMarketingDate": "20200901",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
      "StrengthNumber": "30; 5",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200901",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburns, minor skin irritations or hemmorhoids and itching associated with inflammation, and rashes due to eczema.",
      "Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream Each gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 0.5%."
    },
    {
      "NDCCode": "59088-433-05",
      "PackageDescription": "57 g in 1 TUBE (59088-433-05) ",
      "NDC11Code": "59088-0433-05",
      "ProductNDC": "59088-433",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Circata",
      "NonProprietaryName": "Capsaicin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210902",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "CAPSICUM OLEORESIN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210902",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains."
    },
    {
      "NDCCode": "59088-434-05",
      "PackageDescription": "59 mL in 1 JAR (59088-434-05) ",
      "NDC11Code": "59088-0434-05",
      "ProductNDC": "59088-434",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Capasil",
      "ProprietaryNameSuffix": "Pain Relieving",
      "NonProprietaryName": "Menthol, Methyl Salicylate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201014",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "METHYL SALICYLATE; MENTHOL",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201014",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains."
    },
    {
      "NDCCode": "59088-446-05",
      "PackageDescription": "59 mL in 1 TUBE (59088-446-05) ",
      "NDC11Code": "59088-0446-05",
      "ProductNDC": "59088-446",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Atrix Acne Treatment",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210406",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210406",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ for the treatment of acne ■ dries and clears acne pimples, acne blemishes, whiteheads and blackheads ■ helps prevent the development of new acne pimples, acne blemishes, whiteheads and blackheads."
    },
    {
      "NDCCode": "59088-479-05",
      "PackageDescription": "57 g in 1 TUBE (59088-479-05) ",
      "NDC11Code": "59088-0479-05",
      "ProductNDC": "59088-479",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Circatrix",
      "NonProprietaryName": "Capsaicin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220114",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "CAPSICUM OLEORESIN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220114",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains."
    },
    {
      "NDCCode": "59088-568-05",
      "PackageDescription": "56 mL in 1 BOTTLE (59088-568-05) ",
      "NDC11Code": "59088-0568-05",
      "ProductNDC": "59088-568",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermacinrx Skin Moisturizing Ultra Spf 50 Sunscreen",
      "NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "25; 30; 30; 12.5",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170216",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ Helps prevent sunburn. ■ If used as a directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "59088-627-05",
      "PackageDescription": "57 g in 1 TUBE (59088-627-05) ",
      "NDC11Code": "59088-0627-05",
      "ProductNDC": "59088-627",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zinctral",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230324",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2024-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230324",
      "SamplePackage": "N",
      "IndicationAndUsage": "dries the oozing and weeping of poison:. ivy. oak. sumac. Helps treat and prevent diaper rash. Protects minor skin irritations due to diaper rash and helps protect from wetness."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"59088-233-05","ProprietaryName":"Bruselix Gel","NonProprietaryName":"Lidocaine Hci 3.88%"},{"NDCCode":"12714-233-05","NonProprietaryName":"Tenecteplase"},{"NDCCode":"23155-233-05","ProprietaryName":"Glyburide-metformin Hydrochloride","NonProprietaryName":"Glyburide-metformin Hydrochloride"},{"NDCCode":"42571-233-05","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"50228-233-05","ProprietaryName":"Metoclopramide","NonProprietaryName":"Metoclopramide"},{"NDCCode":"50383-233-05","ProprietaryName":"Dorzolamide Hydrochloride And Timolol Maleate","NonProprietaryName":"Dorzolamide Hydrochloride And Timolol Maleate"},{"NDCCode":"57237-233-05","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"59651-233-05","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"59746-233-05","ProprietaryName":"Oxcarbazepine","NonProprietaryName":"Oxcarbazepine"},{"NDCCode":"64922-233-05","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"68428-233-05","ProprietaryName":"Asclepias Tuberosa","NonProprietaryName":"Asclepias Tuberosa Root"},{"NDCCode":"69367-233-05","ProprietaryName":"Olopatadine Hydrochloride","NonProprietaryName":"Olopatadine Hydrochloride"},{"NDCCode":"70010-233-05","ProprietaryName":"Trazodone Hydrochloride","NonProprietaryName":"Trazodone Hydrochloride"},{"NDCCode":"71052-233-05","NonProprietaryName":"Azithromycin Dihydrate"},{"NDCCode":"72865-233-05","ProprietaryName":"Methocarbamol","NonProprietaryName":"Methocarbamol"},{"NDCCode":"76420-233-05","ProprietaryName":"Zolpidem Tartrate","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"59088-215-05","ProprietaryName":"Mencylate","NonProprietaryName":"Menthol, Methyl Salicylate"},{"NDCCode":"59088-227-05","ProprietaryName":"Salycim","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"59088-234-05","ProprietaryName":"Bruselix Cream","NonProprietaryName":"Lidocaine Hci 3.88%"},{"NDCCode":"59088-351-00","ProprietaryName":"Dermacinrx Cinlone-i Cpi","NonProprietaryName":"Lidocaine And Prilocaine, Triamcinolone Acetonide"},{"NDCCode":"59088-352-00","ProprietaryName":"Dermacinrx Cinlone-ii Cpi","NonProprietaryName":"Lidocaine And Prilocaine, Triamcinolone Acetonide"},{"NDCCode":"59088-378-00","ProprietaryName":"Venipuncture Cpi","NonProprietaryName":"Lidocaine And Prilocaine"},{"NDCCode":"59088-383-00","ProprietaryName":"Iv Infusion Cpi","NonProprietaryName":"Lidocaine And Prilocaine, Sodium Chloride, Povidone-iodine"},{"NDCCode":"59088-430-05","ProprietaryName":"Lidocort","NonProprietaryName":"Lidocaine Hcl - Hydrocortisone Acetate"},{"NDCCode":"59088-433-05","ProprietaryName":"Circata","NonProprietaryName":"Capsaicin"},{"NDCCode":"59088-434-05","ProprietaryName":"Capasil","NonProprietaryName":"Menthol, Methyl Salicylate"},{"NDCCode":"59088-446-05","ProprietaryName":"Atrix Acne Treatment","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"59088-479-05","ProprietaryName":"Circatrix","NonProprietaryName":"Capsaicin"},{"NDCCode":"59088-568-05","ProprietaryName":"Dermacinrx Skin Moisturizing Ultra Spf 50 Sunscreen","NonProprietaryName":"Avobenzone, Octinoxate, Octisalate, Titanium Dioxide"},{"NDCCode":"59088-627-05","ProprietaryName":"Zinctral","NonProprietaryName":"Zinc Oxide"}]}
                    
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  <NDC>
    <NDCCode>59088-233-05</NDCCode>
    <PackageDescription>57 g in 1 TUBE (59088-233-05) </PackageDescription>
    <NDC11Code>59088-0233-05</NDC11Code>
    <ProductNDC>59088-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bruselix Gel</ProprietaryName>
    <NonProprietaryName>Lidocaine Hci 3.88%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240321</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>38.8</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240321</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
    <Description>Bruselix Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxyethylcellulose, PEG-4, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:.</Description>
  </NDC>
  <NDC>
    <NDCCode>12714-233-05</NDCCode>
    <PackageDescription>5 mg in 1 TANK (12714-233-05) </PackageDescription>
    <NDC11Code>12714-0233-05</NDC11Code>
    <ProductNDC>12714-233</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tenecteplase</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>20000602</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
    <SubstanceName>TENECTEPLASE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-05-23</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-JUN-00</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>23155-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (23155-233-05) </PackageDescription>
    <NDC11Code>23155-0233-05</NDC11Code>
    <ProductNDC>23155-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyburide-metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Glyburide-metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079009</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.25; 250</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glyburide and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glyburide and metformin hydrochloride tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetis, glyburide USP and metformin hydrochloride USP. Glyburide, USP is an oral antihyperglycemia sulfonylurea class. The chemical name for glyburide USP is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound with a molecular formula of C23H28ClN3O5S and a molecular weight of 494.01. Micronised glyburide is used in glyburide and metformin hydrochloride tablets, USP. The structural formula is represented below. Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) Is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C4H12CIN5 (monohydrochloride) and a molecular weight of 165.63. Metformin is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin is 6.68. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available for oral administration in tablets containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Povidone, Colloidal Silicon Dioxide, Magnesium Stearate. The tablets are film coated, which provides color differentiation. Additionally 1.25 mg/250 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol and Iron Oxide Yellow. The 2.5 mg/500 mg tablet contains Opadry Pink which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and Iron Oxide Red. The 5 mg/500 mg tablet contains Opadry Yellow which contains Hypromellose, Talc, Titanium Dioxide, Macrogol/PEG 6000, Propylene Glycol, Iron Oxide Yellow and D &amp; C Yellow #10 Aluminium Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-233-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (42571-233-05) </PackageDescription>
    <NDC11Code>42571-0233-05</NDC11Code>
    <ProductNDC>42571-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207471</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).</IndicationAndUsage>
    <Description>Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane­2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>50228-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (50228-233-05) </PackageDescription>
    <NDC11Code>50228-0233-05</NDC11Code>
    <ProductNDC>50228-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoclopramide</ProprietaryName>
    <NonProprietaryName>Metoclopramide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072215</ApplicationNumber>
    <LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoclopramide tablets are indicated for the: : 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1) , 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1) .</IndicationAndUsage>
    <Description>Metoclopramide hydrochloride, the active ingredient of metoclopramide tablets, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. The molecular formula is C 14H 22ClN 3O 2HClH 2O. Its molecular weight is 354.3. The structural formula is:. Metoclopramide tablets are for oral administration. Metoclopramide tablets are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide 5 mg tablet contains 5 mg metoclopramide (equivalent to 5.909 mg of metoclopramide hydrochloride USP). Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate and magnesium stearate., 2 Each metoclopramide 10 mg tablet contains 10 mg metoclopramide (equivalent to 11.818 mg metoclopramide hydrochloride USP). Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50383-233-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (50383-233-05)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>50383-0233-05</NDC11Code>
    <ProductNDC>50383-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20081028</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077847</ApplicationNumber>
    <LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
    <SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>20; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>57237-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (57237-233-05) </PackageDescription>
    <NDC11Code>57237-0233-05</NDC11Code>
    <ProductNDC>57237-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090624</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
    <Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (59651-233-05) </PackageDescription>
    <NDC11Code>59651-0233-05</NDC11Code>
    <ProductNDC>59651-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070886</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
    <Description>Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, in addition 0.1 mg and 0.2 mg contains D&amp;C Yellow No. 10, 0.1 mg and 0.3 mg contains FD&amp;C Blue No. 1, and 0.3 mg contains FD&amp;C Blue No. 2.  Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white or almost white crystalline powder. Soluble in water and ethanol, slightly soluble in chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>59746-233-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59746-233-05)</PackageDescription>
    <NDC11Code>59746-0233-05</NDC11Code>
    <ProductNDC>59746-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxcarbazepine</ProprietaryName>
    <NonProprietaryName>Oxcarbazepine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100214</StartMarketingDate>
    <EndMarketingDate>20150630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090239</ApplicationNumber>
    <LabelerName>JUBILANT CADISTA PHARMACEUTICALS, INC.</LabelerName>
    <SubstanceName>OXCARBAZEPINE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>64922-233-05</NDCCode>
    <PackageDescription>1698 L in 1 CYLINDER (64922-233-05) </PackageDescription>
    <NDC11Code>64922-0233-05</NDC11Code>
    <ProductNDC>64922-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19900101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205767</ApplicationNumber>
    <LabelerName>ADF Welding &amp; Medical, Inc.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68428-233-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-233-05) </PackageDescription>
    <NDC11Code>68428-0233-05</NDC11Code>
    <ProductNDC>68428-233</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Asclepias Tuberosa</ProprietaryName>
    <NonProprietaryName>Asclepias Tuberosa Root</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>ASCLEPIAS TUBEROSA ROOT</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69367-233-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE, DROPPER (69367-233-05) </PackageDescription>
    <NDC11Code>69367-0233-05</NDC11Code>
    <ProductNDC>69367-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olopatadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20190919</StartMarketingDate>
    <EndMarketingDate>20220502</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203152</ApplicationNumber>
    <LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190919</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220502</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70010-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (70010-233-05) </PackageDescription>
    <NDC11Code>70010-0233-05</NDC11Code>
    <ProductNDC>70010-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218988</ApplicationNumber>
    <LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
    <Description>Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, USP, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 1,2,4-Triazolo[4,3-a]pyridin-3(2H)-one, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-, monohydrochloride. It is a white to off white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows. Molecular Formula: C 19H 22CIN 5O  HCl Molecular Weight: 408.32. Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinised starch, sodium lauryl sulphate, sodium starch glycolate type A. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>71052-233-05</NDCCode>
    <PackageDescription>500 g in 1 CONTAINER (71052-233-05) </PackageDescription>
    <NDC11Code>71052-0233-05</NDC11Code>
    <ProductNDC>71052-233</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200420</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>DARMERICA, LLC</LabelerName>
    <SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>g/1000g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-JAN-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>72865-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (72865-233-05) </PackageDescription>
    <NDC11Code>72865-0233-05</NDC11Code>
    <ProductNDC>72865-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methocarbamol</ProprietaryName>
    <NonProprietaryName>Methocarbamol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090200</ApplicationNumber>
    <LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>METHOCARBAMOL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methocarbamol tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
    <Description>Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76420-233-05) </PackageDescription>
    <NDC11Code>76420-0233-05</NDC11Code>
    <ProductNDC>76420-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077903</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-02-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.</IndicationAndUsage>
    <Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-215-05</NDCCode>
    <PackageDescription>59 mL in 1 JAR (59088-215-05) </PackageDescription>
    <NDC11Code>59088-0215-05</NDC11Code>
    <ProductNDC>59088-215</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mencylate</ProprietaryName>
    <ProprietaryNameSuffix>Pain Relieving</ProprietaryNameSuffix>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230324</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>METHYL SALICYLATE; MENTHOL</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with  simple backache  arthritis  strains  bruises  sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-227-05</NDCCode>
    <PackageDescription>57 g in 1 JAR (59088-227-05) </PackageDescription>
    <NDC11Code>59088-0227-05</NDC11Code>
    <ProductNDC>59088-227</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Salycim</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231206</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PURETEK CORPORATION</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-05-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For Dermatologic Use: Salycim Cream is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use: Salycim Cream is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.</IndicationAndUsage>
    <Description>Salycim Cream contains 6% salicylic acid USP in a vehicle consisting of Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Butyrospermum Parkii (Shea) Butter, Carbomer, Cetyl Alcohol, GenRx Complex® (proprietary blend), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Helianthus Annuus (Hybrid Sunflower) Seed Oil, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Hydroxide, Squalane, Stearic Acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-234-05</NDCCode>
    <PackageDescription>57 g in 1 TUBE (59088-234-05) </PackageDescription>
    <NDC11Code>59088-0234-05</NDC11Code>
    <ProductNDC>59088-234</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bruselix Cream</ProprietaryName>
    <NonProprietaryName>Lidocaine Hci 3.88%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>38.8</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
    <Description>Bruselix Cream contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Arnica Montana Flower Extract, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Phosphate, Mineral Oil. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-351-00</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (59088-351-00)  *  5 g in 1 TUBE (0168-0357-05)  *  1 VIAL, MULTI-DOSE in 1 CARTON (0003-0293-05)  &gt; 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>59088-0351-00</NDC11Code>
    <ProductNDC>59088-351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dermacinrx Cinlone-i Cpi</ProprietaryName>
    <NonProprietaryName>Lidocaine And Prilocaine, Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076453</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-25</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>59088-352-00</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (59088-352-00)  *  5 g in 1 TUBE (0168-0357-05)  *  1 VIAL, MULTI-DOSE in 1 CARTON (0003-0293-05)  &gt; 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>59088-0352-00</NDC11Code>
    <ProductNDC>59088-352</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dermacinrx Cinlone-ii Cpi</ProprietaryName>
    <NonProprietaryName>Lidocaine And Prilocaine, Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076453</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-05-17</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>59088-378-00</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (59088-378-00)  *  5 g in 1 TUBE (0168-0357-05)  *  1  in 1 BAG (GS1:19555240400625)</PackageDescription>
    <NDC11Code>59088-0378-00</NDC11Code>
    <ProductNDC>59088-378</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venipuncture Cpi</ProprietaryName>
    <NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160509</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076453</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-05-31</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>59088-383-00</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (59088-383-00)  *  1000 mL in 1 CONTAINER (0264-7800-00)  *  .8 mL in 1 PACKET (10819-3883-1)  *  5 g in 1 TUBE (0168-0357-05)</PackageDescription>
    <NDC11Code>59088-0383-00</NDC11Code>
    <ProductNDC>59088-383</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iv Infusion Cpi</ProprietaryName>
    <NonProprietaryName>Lidocaine And Prilocaine, Sodium Chloride, Povidone-iodine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076453</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59088-430-05</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-430-05) </PackageDescription>
    <NDC11Code>59088-0430-05</NDC11Code>
    <ProductNDC>59088-430</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocort</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>RECTAL; TOPICAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
    <StrengthNumber>30; 5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburns, minor skin irritations or hemmorhoids and itching associated with inflammation, and rashes due to eczema.</IndicationAndUsage>
    <Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream Each gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 0.5%.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-433-05</NDCCode>
    <PackageDescription>57 g in 1 TUBE (59088-433-05) </PackageDescription>
    <NDC11Code>59088-0433-05</NDC11Code>
    <ProductNDC>59088-433</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Circata</ProprietaryName>
    <NonProprietaryName>Capsaicin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210902</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>CAPSICUM OLEORESIN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210902</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-434-05</NDCCode>
    <PackageDescription>59 mL in 1 JAR (59088-434-05) </PackageDescription>
    <NDC11Code>59088-0434-05</NDC11Code>
    <ProductNDC>59088-434</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Capasil</ProprietaryName>
    <ProprietaryNameSuffix>Pain Relieving</ProprietaryNameSuffix>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201014</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>METHYL SALICYLATE; MENTHOL</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-446-05</NDCCode>
    <PackageDescription>59 mL in 1 TUBE (59088-446-05) </PackageDescription>
    <NDC11Code>59088-0446-05</NDC11Code>
    <ProductNDC>59088-446</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Atrix Acne Treatment</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210406</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ for the treatment of acne ■ dries and clears acne pimples, acne blemishes, whiteheads and blackheads ■ helps prevent the development of new acne pimples, acne blemishes, whiteheads and blackheads.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-479-05</NDCCode>
    <PackageDescription>57 g in 1 TUBE (59088-479-05) </PackageDescription>
    <NDC11Code>59088-0479-05</NDC11Code>
    <ProductNDC>59088-479</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Circatrix</ProprietaryName>
    <NonProprietaryName>Capsaicin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220114</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>CAPSICUM OLEORESIN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-568-05</NDCCode>
    <PackageDescription>56 mL in 1 BOTTLE (59088-568-05) </PackageDescription>
    <NDC11Code>59088-0568-05</NDC11Code>
    <ProductNDC>59088-568</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermacinrx Skin Moisturizing Ultra Spf 50 Sunscreen</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>25; 30; 30; 12.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ Helps prevent sunburn. ■ If used as a directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-627-05</NDCCode>
    <PackageDescription>57 g in 1 TUBE (59088-627-05) </PackageDescription>
    <NDC11Code>59088-0627-05</NDC11Code>
    <ProductNDC>59088-627</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zinctral</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230324</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>dries the oozing and weeping of poison:. ivy. oak. sumac. Helps treat and prevent diaper rash. Protects minor skin irritations due to diaper rash and helps protect from wetness.</IndicationAndUsage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>59088-233-05</NDCCode><ProprietaryName>Bruselix Gel</ProprietaryName><NonProprietaryName>Lidocaine Hci 3.88%</NonProprietaryName></NDC><NDC><NDCCode>12714-233-05</NDCCode><NonProprietaryName>Tenecteplase</NonProprietaryName></NDC><NDC><NDCCode>23155-233-05</NDCCode><ProprietaryName>Glyburide-metformin Hydrochloride</ProprietaryName><NonProprietaryName>Glyburide-metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-233-05</NDCCode><ProprietaryName>Amoxicillin</ProprietaryName><NonProprietaryName>Amoxicillin</NonProprietaryName></NDC><NDC><NDCCode>50228-233-05</NDCCode><ProprietaryName>Metoclopramide</ProprietaryName><NonProprietaryName>Metoclopramide</NonProprietaryName></NDC><NDC><NDCCode>50383-233-05</NDCCode><ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName><NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>57237-233-05</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>59651-233-05</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59746-233-05</NDCCode><ProprietaryName>Oxcarbazepine</ProprietaryName><NonProprietaryName>Oxcarbazepine</NonProprietaryName></NDC><NDC><NDCCode>64922-233-05</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>68428-233-05</NDCCode><ProprietaryName>Asclepias Tuberosa</ProprietaryName><NonProprietaryName>Asclepias Tuberosa Root</NonProprietaryName></NDC><NDC><NDCCode>69367-233-05</NDCCode><ProprietaryName>Olopatadine Hydrochloride</ProprietaryName><NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70010-233-05</NDCCode><ProprietaryName>Trazodone Hydrochloride</ProprietaryName><NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71052-233-05</NDCCode><NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>72865-233-05</NDCCode><ProprietaryName>Methocarbamol</ProprietaryName><NonProprietaryName>Methocarbamol</NonProprietaryName></NDC><NDC><NDCCode>76420-233-05</NDCCode><ProprietaryName>Zolpidem Tartrate</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>59088-215-05</NDCCode><ProprietaryName>Mencylate</ProprietaryName><NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>59088-227-05</NDCCode><ProprietaryName>Salycim</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>59088-234-05</NDCCode><ProprietaryName>Bruselix Cream</ProprietaryName><NonProprietaryName>Lidocaine Hci 3.88%</NonProprietaryName></NDC><NDC><NDCCode>59088-351-00</NDCCode><ProprietaryName>Dermacinrx Cinlone-i Cpi</ProprietaryName><NonProprietaryName>Lidocaine And Prilocaine, Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>59088-352-00</NDCCode><ProprietaryName>Dermacinrx Cinlone-ii Cpi</ProprietaryName><NonProprietaryName>Lidocaine And Prilocaine, Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>59088-378-00</NDCCode><ProprietaryName>Venipuncture Cpi</ProprietaryName><NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName></NDC><NDC><NDCCode>59088-383-00</NDCCode><ProprietaryName>Iv Infusion Cpi</ProprietaryName><NonProprietaryName>Lidocaine And Prilocaine, Sodium Chloride, Povidone-iodine</NonProprietaryName></NDC><NDC><NDCCode>59088-430-05</NDCCode><ProprietaryName>Lidocort</ProprietaryName><NonProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>59088-433-05</NDCCode><ProprietaryName>Circata</ProprietaryName><NonProprietaryName>Capsaicin</NonProprietaryName></NDC><NDC><NDCCode>59088-434-05</NDCCode><ProprietaryName>Capasil</ProprietaryName><NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>59088-446-05</NDCCode><ProprietaryName>Atrix Acne Treatment</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>59088-479-05</NDCCode><ProprietaryName>Circatrix</ProprietaryName><NonProprietaryName>Capsaicin</NonProprietaryName></NDC><NDC><NDCCode>59088-568-05</NDCCode><ProprietaryName>Dermacinrx Skin Moisturizing Ultra Spf 50 Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>59088-627-05</NDCCode><ProprietaryName>Zinctral</ProprietaryName><NonProprietaryName>Zinc Oxide</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",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

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

How does it work

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

Full Text Search & DataLabs REST API

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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