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How to Find 0406-0147-15 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "0406-0147-15",
      "PackageDescription": "700 kg in 1 SUPERSACK (0406-0147-15)",
      "NDC11Code": "00406-0147-15",
      "ProductNDC": "0406-0147",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "P-aminophenol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130219",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Mallinckrodt, Inc.",
      "SubstanceName": "P-AMINOPHENOL",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0406-0147-26",
      "PackageDescription": "100 kg in 1 DRUM (0406-0147-26)",
      "NDC11Code": "00406-0147-26",
      "ProductNDC": "0406-0147",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "P-aminophenol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130219",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Mallinckrodt, Inc.",
      "SubstanceName": "P-AMINOPHENOL",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0245-0147-15",
      "PackageDescription": "500 TABLET in 1 BOTTLE (0245-0147-15) ",
      "NDC11Code": "00245-0147-15",
      "ProductNDC": "0245-0147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pacerone",
      "NonProprietaryName": "Amiodarone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075135",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "AMIODARONE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.",
      "Description": "Pacerone (amiodarone hydrochloride tablets, USP) are an antiarrhythmic drug, available for oral administration as 100 mg; peach tablets, 200 mg; pink tablets and 400 mg; white tablets containing amiodarone hydrochloride, USP. All three strengths of Pacerone tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized corn starch, sodium starch glycolate and stearic acid. The 200 mg tablets also contain FD&C Red No. 40 and FD&C Yellow No. 6. The 100 mg tablets also contain FD&C Yellow No. 6. Amiodarone hydrochloride, USP is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows. C 25H 29I 2NO 3∙ HCl                                              Molecular Weight: 681.8. C 25H 29I 2NO 3∙ HCl                                              Molecular Weight: 681.8. Amiodarone hydrochloride, USP is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Meets USP Dissolution Test 4."
    },
    {
      "NDCCode": "11523-0147-1",
      "PackageDescription": "1 KIT in 1 CARTON (11523-0147-1)  *  15 mL in 1 BOTTLE, SPRAY *  15 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "11523-0147-01",
      "ProductNDC": "11523-0147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Afrin No Drip",
      "ProprietaryNameSuffix": "Pump Mist Bundle Pack",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "KIT",
      "RouteName": "NASAL",
      "StartMarketingDate": "20240419",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Bayer HealthCare LLC.",
      "Status": "Active",
      "LastUpdate": "2025-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240419",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves nasal congestion due to: common coldhay feverupper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen nasal membranes so you can breathe more freely."
    },
    {
      "NDCCode": "11673-147-15",
      "PackageDescription": "150 mL in 1 TUBE (11673-147-15) ",
      "NDC11Code": "11673-0147-15",
      "ProductNDC": "11673-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Target Up And Up 2-in-1 Hand Sanitizer",
      "NonProprietaryName": "Benzethonium Chloride",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210517",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "TARGET CORPORATION",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210517",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps decrease bacteria on the hands."
    },
    {
      "NDCCode": "20276-147-15",
      "PackageDescription": "444 mL in 1 BOTTLE, PLASTIC (20276-147-15) ",
      "NDC11Code": "20276-0147-15",
      "ProductNDC": "20276-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lucky",
      "ProprietaryNameSuffix": "Antibacterial",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160510",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Delta Brands, Inc",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20201104",
      "SamplePackage": "N",
      "IndicationAndUsage": "for hand washing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "21695-147-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (21695-147-15)",
      "NDC11Code": "21695-0147-15",
      "ProductNDC": "21695-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Actos",
      "NonProprietaryName": "Pioglitazone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19990715",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021073",
      "LabelerName": "Rebel Distributors Corp.",
      "SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. ACTOS is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes). Pharmacological studies indicate that ACTOS improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. ACTOS improves glycemic control while reducing circulating insulin levels.       Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride belongs to a different chemical class and has a different pharmacological action than the sulfonylureas, metformin, or the α-glucosidase inhibitors. The molecule contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:.       Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.       ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF."
    },
    {
      "NDCCode": "24909-147-15",
      "PackageDescription": "14 g in 1 TUBE (24909-147-15) ",
      "NDC11Code": "24909-0147-15",
      "ProductNDC": "24909-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Terrasil Ipl Relief",
      "ProprietaryNameSuffix": "Maximum Strength",
      "NonProprietaryName": "Thuja Occidentalis",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140314",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Aidance Skincare & Topical Solutions, LLC",
      "SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
      "StrengthNumber": "3",
      "StrengthUnit": "[hp_X]/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20181229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Relief from symptoms of itch, papules (bumps) and lesions often associated with Molluscum per diagnosis and care by physician."
    },
    {
      "NDCCode": "33261-147-15",
      "PackageDescription": "15 CAPSULE in 1 BOTTLE, PLASTIC (33261-147-15)",
      "NDC11Code": "33261-0147-15",
      "ProductNDC": "33261-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benzonatate",
      "NonProprietaryName": "Benzonatate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070725",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040627",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "BENZONATATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Benzonatate is indicated for the symptomatic relief of cough.",
      "Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow # 10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide."
    },
    {
      "NDCCode": "43353-147-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (43353-147-15)",
      "NDC11Code": "43353-0147-15",
      "ProductNDC": "43353-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aripiprazole",
      "NonProprietaryName": "Aripiprazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150728",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078583",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "ARIPIPRAZOLE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-17",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231"
    },
    {
      "NDCCode": "43744-147-15",
      "PackageDescription": "10 g in 1 DRUM (43744-147-15)",
      "NDC11Code": "43744-0147-15",
      "ProductNDC": "43744-147",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cefpodoxime Proxetil",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130624",
      "EndMarketingDate": "20130630",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "CEFPODOXIME PROXETIL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130630"
    },
    {
      "NDCCode": "55289-147-15",
      "PackageDescription": "15 CAPSULE in 1 BOTTLE, PLASTIC (55289-147-15) ",
      "NDC11Code": "55289-0147-15",
      "ProductNDC": "55289-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Indomethacin",
      "NonProprietaryName": "Indomethacin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19840420",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018858",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "INDOMETHACIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-08-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20080313",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67046-147-15",
      "PackageDescription": "15 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-15)",
      "NDC11Code": "67046-0147-15",
      "ProductNDC": "67046-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Divalproex Sodium",
      "NonProprietaryName": "Divalproex Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170925",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079163",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "DIVALPROEX SODIUM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Divalproex sodium delayed release tablets are an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches (  1.3)  .",
      "Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets are for oral administration. Divalproex sodium delayed release tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets: Microcrystalline cellulose, silicon dioxide, pregelatinized starch (contains corn starch), povidone, talc, opadry II white 33G28707, simethicone and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, ethanol and isopropyl alcohol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
    },
    {
      "NDCCode": "71630-147-15",
      "PackageDescription": "50 g in 1 BOTTLE, PUMP (71630-147-15) ",
      "NDC11Code": "71630-0147-15",
      "ProductNDC": "71630-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Doterra Sun Face Daily Moisturizer",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "doTERRA International, LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "13",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "0363-0406-15",
      "PackageDescription": "198.1 mL in 1 TUBE (0363-0406-15) ",
      "NDC11Code": "00363-0406-15",
      "ProductNDC": "0363-0406",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Walgreens Pink Grapefruit Acne Wash",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "WALGREEN COMPANY",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241216",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the treatment of acne."
    },
    {
      "NDCCode": "0406-0527-15",
      "PackageDescription": "15000 mL in 1 BOTTLE, PLASTIC (0406-0527-15) ",
      "NDC11Code": "00406-0527-15",
      "ProductNDC": "0406-0527",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methadose",
      "NonProprietaryName": "Methadone Hydrochloride",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19730314",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017116",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "METHADONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19730314",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0406-1516-42",
      "PackageDescription": "15 kg in 1 DRUM (0406-1516-42) ",
      "NDC11Code": "00406-1516-42",
      "ProductNDC": "0406-1516",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130401",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "95",
      "StrengthUnit": "kg/95kg",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2025-07-22",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-25"
    },
    {
      "NDCCode": "0406-2257-15",
      "PackageDescription": "22 kg in 1 CONTAINER (0406-2257-15)",
      "NDC11Code": "00406-2257-15",
      "ProductNDC": "0406-2257",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Magnesium Stearate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20030101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "MAGNESIUM STEARATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "0406-8003-15",
      "PackageDescription": "6 CARTON in 1 CASE (0406-8003-15)  / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00406-8003-15",
      "ProductNDC": "0406-8003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110715",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202348",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate oral solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
      "Description": "Morphine sulfate oral solution is an opioid agonist, available in the following concentration for oral administration: 1 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine)."
    },
    {
      "NDCCode": "0406-8725-15",
      "PackageDescription": "15000 mL in 1 BOTTLE, PLASTIC (0406-8725-15) ",
      "NDC11Code": "00406-8725-15",
      "ProductNDC": "0406-8725",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methadose",
      "ProprietaryNameSuffix": "Sugar-free",
      "NonProprietaryName": "Methadone Hydrochloride",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19730314",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017116",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "METHADONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19730314",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "33342-406-15",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-15) ",
      "NDC11Code": "33342-0406-15",
      "ProductNDC": "33342-406",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
      "NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260406",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211559",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "5; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260406",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dapagliflozin and metformin hydrochloride extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of.  Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression.  Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure.  Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use.  Dapagliflozin and metformin hydrochloride extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2)].  Because of the metformin HCl component, the use of dapagliflozin and metformin hydrochloride extended-release tablets is limited to patients with type 2 diabetes mellitus for all indications.  Dapagliflozin and metformin hydrochloride extended-release tablets are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dapagliflozin and metformin hydrochloride extended-release tablets are not expected to be effective in these populations. Pediatric use information is approved for AstraZeneca AB’s Xigduo® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. DapagliflozinDapagliflozin is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.87. The structural formula is.   Metformin HClMetformin HCl (N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, 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 HCl is 6.68. The structural formula is. Dapagliflozin and metformin hydrochloride extended-release tabletsDapagliflozin and metformin hydrochloride extended-release tablets is available for oral administration as tablets containing the 5 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg), or 10 mg dapagliflozin and 1000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, sodium carboxymethylcellulose. Dry mixing of Dapagliflozin layer contains following- 5 mg/500 mg and 5mg/1000 mg strength tablets contain red iron oxide and the 10 mg/500 mg and 10 mg/1,000 mg strength tablets contain yellow iron oxide. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/ 500 mg contains FD and C Yellow No.6 Al. Lake, 5 mg/ 1000 mg and 10 mg/500 mg contains red iron oxide, 10 mg/1000 mg contains yellow iron oxide."
    },
    {
      "NDCCode": "43063-406-15",
      "PackageDescription": "15 CAPSULE in 1 BOTTLE, PLASTIC (43063-406-15) ",
      "NDC11Code": "43063-0406-15",
      "ProductNDC": "43063-406",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxyzine Pamoate",
      "NonProprietaryName": "Hydroxyzine Pamoate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19811214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087479",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROXYZINE PAMOATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140701",
      "SamplePackage": "N",
      "IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
      "Description": "Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows. C 21H 27CIN 2O 2C 23H 16O 6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze."
    },
    {
      "NDCCode": "50268-406-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOX (50268-406-15)  / 1 TABLET in 1 BLISTER PACK (50268-406-11) ",
      "NDC11Code": "50268-0406-15",
      "ProductNDC": "50268-406",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040646",
      "LabelerName": "AvPAK",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230131",
      "SamplePackage": "N",
      "Description": "Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3, 20-dione,11,17,21-trihydroxy-,(11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: lactose, pregelatinized corn starch, microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, and magnesium stearate."
    },
    {
      "NDCCode": "55289-406-15",
      "PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-406-15) ",
      "NDC11Code": "55289-0406-15",
      "ProductNDC": "55289-406",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arthrotec",
      "NonProprietaryName": "Diclofenac Sodium And Misoprostol",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19971224",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020607",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
      "StrengthNumber": "50; 200",
      "StrengthUnit": "mg/1; ug/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20110728",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55319-406-15",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55319-406-15)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "55319-0406-15",
      "ProductNDC": "55319-406",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204872",
      "LabelerName": "Family Dollar Services Inc",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "220",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231215",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachemuscular achesthe common coldtoothachemenstrual crampsbackacheminor pain of arthritis. temporarily reduces fever."
    },
    {
      "NDCCode": "63187-406-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (63187-406-15) ",
      "NDC11Code": "63187-0406-15",
      "ProductNDC": "63187-406",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040105",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets are indicated for the relief of moderate to moderately severe pain.",
      "Description": "Each tablet, for oral administration, contains: 1  Oxycodone hydrochloride, USP ................................................................. 5 mg (equivalent to 4.4815 mg of Oxycodone) Acetaminophen, USP .............................................................................. 325 mg."
    },
    {
      "NDCCode": "65197-406-15",
      "PackageDescription": "1 TUBE in 1 BOX (65197-406-15)  / 42.5 g in 1 TUBE",
      "NDC11Code": "65197-0406-15",
      "ProductNDC": "65197-406",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ad Medicated Rash",
      "NonProprietaryName": "Ad Medicated Rash",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "WellSpring Pharmaceutical Corporation",
      "SubstanceName": "MINERAL OIL; OATMEAL",
      "StrengthNumber": "30; 2",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to: 1 rashes , 2 eczema."
    },
    {
      "NDCCode": "66336-406-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (66336-406-15)",
      "NDC11Code": "66336-0406-15",
      "ProductNDC": "66336-406",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040143",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 650",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
    },
    {
      "NDCCode": "72789-406-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (72789-406-15) ",
      "NDC11Code": "72789-0406-15",
      "ProductNDC": "72789-406",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil Citrate",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200904",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209302",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240607",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
      "Description": "Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "10572-147-62",
      "PackageDescription": "480 mL in 1 BOTTLE, PLASTIC (10572-147-62)",
      "NDC11Code": "10572-0147-62",
      "ProductNDC": "10572-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nizatidine",
      "NonProprietaryName": "Nizatidine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091218",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021494",
      "LabelerName": "Affordable Pharmaceuticals, LLC",
      "SubstanceName": "NIZATIDINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2015-03-06"
    }
  ]
}
                    
{"NDC":[{"NDCCode":"0406-0147-15","NonProprietaryName":"P-aminophenol"},{"NDCCode":"0406-0147-26","NonProprietaryName":"P-aminophenol"},{"NDCCode":"0245-0147-15","ProprietaryName":"Pacerone","NonProprietaryName":"Amiodarone Hydrochloride"},{"NDCCode":"11523-0147-1","ProprietaryName":"Afrin No Drip","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"11673-147-15","ProprietaryName":"Target Up And Up 2-in-1 Hand Sanitizer","NonProprietaryName":"Benzethonium Chloride"},{"NDCCode":"20276-147-15","ProprietaryName":"Lucky","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"21695-147-15","ProprietaryName":"Actos","NonProprietaryName":"Pioglitazone Hydrochloride"},{"NDCCode":"24909-147-15","ProprietaryName":"Terrasil Ipl Relief","NonProprietaryName":"Thuja Occidentalis"},{"NDCCode":"33261-147-15","ProprietaryName":"Benzonatate","NonProprietaryName":"Benzonatate"},{"NDCCode":"43353-147-15","ProprietaryName":"Aripiprazole","NonProprietaryName":"Aripiprazole"},{"NDCCode":"43744-147-15","NonProprietaryName":"Cefpodoxime Proxetil"},{"NDCCode":"55289-147-15","ProprietaryName":"Indomethacin","NonProprietaryName":"Indomethacin"},{"NDCCode":"67046-147-15","ProprietaryName":"Divalproex Sodium","NonProprietaryName":"Divalproex Sodium"},{"NDCCode":"71630-147-15","ProprietaryName":"Doterra Sun Face Daily Moisturizer","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"0363-0406-15","ProprietaryName":"Walgreens Pink Grapefruit Acne Wash","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"0406-0527-15","ProprietaryName":"Methadose","NonProprietaryName":"Methadone Hydrochloride"},{"NDCCode":"0406-1516-42","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"0406-2257-15","NonProprietaryName":"Magnesium Stearate"},{"NDCCode":"0406-8003-15","ProprietaryName":"Morphine Sulfate","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"0406-8725-15","ProprietaryName":"Methadose","NonProprietaryName":"Methadone Hydrochloride"},{"NDCCode":"33342-406-15","ProprietaryName":"Dapagliflozin And Metformin Hydrochloride","NonProprietaryName":"Dapagliflozin And Metformin Hydrochloride"},{"NDCCode":"43063-406-15","ProprietaryName":"Hydroxyzine Pamoate","NonProprietaryName":"Hydroxyzine Pamoate"},{"NDCCode":"50268-406-15","ProprietaryName":"Hydrocortisone","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"55289-406-15","ProprietaryName":"Arthrotec","NonProprietaryName":"Diclofenac Sodium And Misoprostol"},{"NDCCode":"55319-406-15","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"63187-406-15","ProprietaryName":"Oxycodone And Acetaminophen","NonProprietaryName":"Oxycodone Hydrochloride And Acetaminophen"},{"NDCCode":"65197-406-15","ProprietaryName":"Ad Medicated Rash","NonProprietaryName":"Ad Medicated Rash"},{"NDCCode":"66336-406-15","ProprietaryName":"Hydrocodone Bitartrate And Acetaminophen","NonProprietaryName":"Hydrocodone Bitartrate And Acetaminophen"},{"NDCCode":"72789-406-15","ProprietaryName":"Sildenafil Citrate","NonProprietaryName":"Sildenafil Citrate"},{"NDCCode":"10572-147-62","ProprietaryName":"Nizatidine","NonProprietaryName":"Nizatidine"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>0406-0147-15</NDCCode>
    <PackageDescription>700 kg in 1 SUPERSACK (0406-0147-15)</PackageDescription>
    <NDC11Code>00406-0147-15</NDC11Code>
    <ProductNDC>0406-0147</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>P-aminophenol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130219</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Mallinckrodt, Inc.</LabelerName>
    <SubstanceName>P-AMINOPHENOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0406-0147-26</NDCCode>
    <PackageDescription>100 kg in 1 DRUM (0406-0147-26)</PackageDescription>
    <NDC11Code>00406-0147-26</NDC11Code>
    <ProductNDC>0406-0147</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>P-aminophenol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130219</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Mallinckrodt, Inc.</LabelerName>
    <SubstanceName>P-AMINOPHENOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0245-0147-15</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (0245-0147-15) </PackageDescription>
    <NDC11Code>00245-0147-15</NDC11Code>
    <ProductNDC>0245-0147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pacerone</ProprietaryName>
    <NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075135</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.</IndicationAndUsage>
    <Description>Pacerone (amiodarone hydrochloride tablets, USP) are an antiarrhythmic drug, available for oral administration as 100 mg; peach tablets, 200 mg; pink tablets and 400 mg; white tablets containing amiodarone hydrochloride, USP. All three strengths of Pacerone tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized corn starch, sodium starch glycolate and stearic acid. The 200 mg tablets also contain FD&amp;C Red No. 40 and FD&amp;C Yellow No. 6. The 100 mg tablets also contain FD&amp;C Yellow No. 6. Amiodarone hydrochloride, USP is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows. C 25H 29I 2NO 3∙ HCl                                              Molecular Weight: 681.8. C 25H 29I 2NO 3∙ HCl                                              Molecular Weight: 681.8. Amiodarone hydrochloride, USP is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>11523-0147-1</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (11523-0147-1)  *  15 mL in 1 BOTTLE, SPRAY *  15 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>11523-0147-01</NDC11Code>
    <ProductNDC>11523-0147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Afrin No Drip</ProprietaryName>
    <ProprietaryNameSuffix>Pump Mist Bundle Pack</ProprietaryNameSuffix>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20240419</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Bayer HealthCare LLC.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240419</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves nasal congestion due to: common coldhay feverupper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11673-147-15</NDCCode>
    <PackageDescription>150 mL in 1 TUBE (11673-147-15) </PackageDescription>
    <NDC11Code>11673-0147-15</NDC11Code>
    <ProductNDC>11673-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Target Up And Up 2-in-1 Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210517</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>TARGET CORPORATION</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps decrease bacteria on the hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>20276-147-15</NDCCode>
    <PackageDescription>444 mL in 1 BOTTLE, PLASTIC (20276-147-15) </PackageDescription>
    <NDC11Code>20276-0147-15</NDC11Code>
    <ProductNDC>20276-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lucky</ProprietaryName>
    <ProprietaryNameSuffix>Antibacterial</ProprietaryNameSuffix>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160510</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Delta Brands, Inc</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for hand washing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21695-147-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (21695-147-15)</PackageDescription>
    <NDC11Code>21695-0147-15</NDC11Code>
    <ProductNDC>21695-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Actos</ProprietaryName>
    <NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19990715</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021073</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp.</LabelerName>
    <SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. ACTOS is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes). Pharmacological studies indicate that ACTOS improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. ACTOS improves glycemic control while reducing circulating insulin levels.       Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride belongs to a different chemical class and has a different pharmacological action than the sulfonylureas, metformin, or the α-glucosidase inhibitors. The molecule contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:.       Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.       ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>24909-147-15</NDCCode>
    <PackageDescription>14 g in 1 TUBE (24909-147-15) </PackageDescription>
    <NDC11Code>24909-0147-15</NDC11Code>
    <ProductNDC>24909-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Terrasil Ipl Relief</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140314</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Aidance Skincare &amp; Topical Solutions, LLC</LabelerName>
    <SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>[hp_X]/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Relief from symptoms of itch, papules (bumps) and lesions often associated with Molluscum per diagnosis and care by physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33261-147-15</NDCCode>
    <PackageDescription>15 CAPSULE in 1 BOTTLE, PLASTIC (33261-147-15)</PackageDescription>
    <NDC11Code>33261-0147-15</NDC11Code>
    <ProductNDC>33261-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benzonatate</ProprietaryName>
    <NonProprietaryName>Benzonatate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040627</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BENZONATATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Benzonatate is indicated for the symptomatic relief of cough.</IndicationAndUsage>
    <Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&amp;C Yellow # 10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-147-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (43353-147-15)</PackageDescription>
    <NDC11Code>43353-0147-15</NDC11Code>
    <ProductNDC>43353-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078583</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-17</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-147-15</NDCCode>
    <PackageDescription>10 g in 1 DRUM (43744-147-15)</PackageDescription>
    <NDC11Code>43744-0147-15</NDC11Code>
    <ProductNDC>43744-147</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cefpodoxime Proxetil</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130624</StartMarketingDate>
    <EndMarketingDate>20130630</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>CEFPODOXIME PROXETIL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55289-147-15</NDCCode>
    <PackageDescription>15 CAPSULE in 1 BOTTLE, PLASTIC (55289-147-15) </PackageDescription>
    <NDC11Code>55289-0147-15</NDC11Code>
    <ProductNDC>55289-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Indomethacin</ProprietaryName>
    <NonProprietaryName>Indomethacin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840420</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018858</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>INDOMETHACIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67046-147-15</NDCCode>
    <PackageDescription>15 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-15)</PackageDescription>
    <NDC11Code>67046-0147-15</NDC11Code>
    <ProductNDC>67046-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Divalproex Sodium</ProprietaryName>
    <NonProprietaryName>Divalproex Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170925</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079163</ApplicationNumber>
    <LabelerName>Contract Pharmacy Services-PA</LabelerName>
    <SubstanceName>DIVALPROEX SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Divalproex sodium delayed release tablets are an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches (  1.3)  .</IndicationAndUsage>
    <Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets are for oral administration. Divalproex sodium delayed release tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets: Microcrystalline cellulose, silicon dioxide, pregelatinized starch (contains corn starch), povidone, talc, opadry II white 33G28707, simethicone and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, ethanol and isopropyl alcohol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD &amp; C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate &amp; yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D &amp; C Red No. 30, FD &amp; C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD &amp; C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>71630-147-15</NDCCode>
    <PackageDescription>50 g in 1 BOTTLE, PUMP (71630-147-15) </PackageDescription>
    <NDC11Code>71630-0147-15</NDC11Code>
    <ProductNDC>71630-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Doterra Sun Face Daily Moisturizer</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>doTERRA International, LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>13</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-02-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0363-0406-15</NDCCode>
    <PackageDescription>198.1 mL in 1 TUBE (0363-0406-15) </PackageDescription>
    <NDC11Code>00363-0406-15</NDC11Code>
    <ProductNDC>0363-0406</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Walgreens Pink Grapefruit Acne Wash</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>WALGREEN COMPANY</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0406-0527-15</NDCCode>
    <PackageDescription>15000 mL in 1 BOTTLE, PLASTIC (0406-0527-15) </PackageDescription>
    <NDC11Code>00406-0527-15</NDC11Code>
    <ProductNDC>0406-0527</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadose</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19730314</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017116</ApplicationNumber>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19730314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0406-1516-42</NDCCode>
    <PackageDescription>15 kg in 1 DRUM (0406-1516-42) </PackageDescription>
    <NDC11Code>00406-1516-42</NDC11Code>
    <ProductNDC>0406-1516</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130401</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>95</StrengthNumber>
    <StrengthUnit>kg/95kg</StrengthUnit>
    <DEASchedule>CII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2025-07-22</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0406-2257-15</NDCCode>
    <PackageDescription>22 kg in 1 CONTAINER (0406-2257-15)</PackageDescription>
    <NDC11Code>00406-2257-15</NDC11Code>
    <ProductNDC>0406-2257</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Magnesium Stearate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20030101</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>MAGNESIUM STEARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0406-8003-15</NDCCode>
    <PackageDescription>6 CARTON in 1 CASE (0406-8003-15)  / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00406-8003-15</NDC11Code>
    <ProductNDC>0406-8003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202348</ApplicationNumber>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate oral solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Morphine sulfate oral solution is an opioid agonist, available in the following concentration for oral administration: 1 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).</Description>
  </NDC>
  <NDC>
    <NDCCode>0406-8725-15</NDCCode>
    <PackageDescription>15000 mL in 1 BOTTLE, PLASTIC (0406-8725-15) </PackageDescription>
    <NDC11Code>00406-8725-15</NDC11Code>
    <ProductNDC>0406-8725</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadose</ProprietaryName>
    <ProprietaryNameSuffix>Sugar-free</ProprietaryNameSuffix>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19730314</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017116</ApplicationNumber>
    <LabelerName>SpecGx LLC</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19730314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>33342-406-15</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-15) </PackageDescription>
    <NDC11Code>33342-0406-15</NDC11Code>
    <ProductNDC>33342-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211559</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 500</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dapagliflozin and metformin hydrochloride extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of.  Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression.  Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure.  Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use.  Dapagliflozin and metformin hydrochloride extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2)].  Because of the metformin HCl component, the use of dapagliflozin and metformin hydrochloride extended-release tablets is limited to patients with type 2 diabetes mellitus for all indications.  Dapagliflozin and metformin hydrochloride extended-release tablets are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dapagliflozin and metformin hydrochloride extended-release tablets are not expected to be effective in these populations. Pediatric use information is approved for AstraZeneca AB’s Xigduo® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. DapagliflozinDapagliflozin is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.87. The structural formula is.   Metformin HClMetformin HCl (N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, 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 HCl is 6.68. The structural formula is. Dapagliflozin and metformin hydrochloride extended-release tabletsDapagliflozin and metformin hydrochloride extended-release tablets is available for oral administration as tablets containing the 5 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg), or 10 mg dapagliflozin and 1000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, sodium carboxymethylcellulose. Dry mixing of Dapagliflozin layer contains following- 5 mg/500 mg and 5mg/1000 mg strength tablets contain red iron oxide and the 10 mg/500 mg and 10 mg/1,000 mg strength tablets contain yellow iron oxide. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/ 500 mg contains FD and C Yellow No.6 Al. Lake, 5 mg/ 1000 mg and 10 mg/500 mg contains red iron oxide, 10 mg/1000 mg contains yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-406-15</NDCCode>
    <PackageDescription>15 CAPSULE in 1 BOTTLE, PLASTIC (43063-406-15) </PackageDescription>
    <NDC11Code>43063-0406-15</NDC11Code>
    <ProductNDC>43063-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19811214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087479</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows. C 21H 27CIN 2O 2C 23H 16O 6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&amp;C Yellow #10, FD&amp;C Green #3, FD&amp;C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Blue #2, FD&amp;C Red #40, propylene glycol, and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>50268-406-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX (50268-406-15)  / 1 TABLET in 1 BLISTER PACK (50268-406-11) </PackageDescription>
    <NDC11Code>50268-0406-15</NDC11Code>
    <ProductNDC>50268-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040646</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3, 20-dione,11,17,21-trihydroxy-,(11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: lactose, pregelatinized corn starch, microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-406-15</NDCCode>
    <PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-406-15) </PackageDescription>
    <NDC11Code>55289-0406-15</NDC11Code>
    <ProductNDC>55289-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Arthrotec</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19971224</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020607</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
    <StrengthNumber>50; 200</StrengthNumber>
    <StrengthUnit>mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55319-406-15</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55319-406-15)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>55319-0406-15</NDC11Code>
    <ProductNDC>55319-406</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204872</ApplicationNumber>
    <LabelerName>Family Dollar Services Inc</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>220</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:headachemuscular achesthe common coldtoothachemenstrual crampsbackacheminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63187-406-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (63187-406-15) </PackageDescription>
    <NDC11Code>63187-0406-15</NDC11Code>
    <ProductNDC>63187-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040105</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
    <Description>Each tablet, for oral administration, contains: 1  Oxycodone hydrochloride, USP ................................................................. 5 mg (equivalent to 4.4815 mg of Oxycodone) Acetaminophen, USP .............................................................................. 325 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>65197-406-15</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (65197-406-15)  / 42.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>65197-0406-15</NDC11Code>
    <ProductNDC>65197-406</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ad Medicated Rash</ProprietaryName>
    <NonProprietaryName>Ad Medicated Rash</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>WellSpring Pharmaceutical Corporation</LabelerName>
    <SubstanceName>MINERAL OIL; OATMEAL</SubstanceName>
    <StrengthNumber>30; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects and helps relieve minor skin irritation and itching due to: 1 rashes , 2 eczema.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66336-406-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (66336-406-15)</PackageDescription>
    <NDC11Code>66336-0406-15</NDC11Code>
    <ProductNDC>66336-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040143</ApplicationNumber>
    <LabelerName>Dispensing Solutions, Inc.</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 650</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72789-406-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (72789-406-15) </PackageDescription>
    <NDC11Code>72789-0406-15</NDC11Code>
    <ProductNDC>72789-406</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil Citrate</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200904</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209302</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&amp;C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>10572-147-62</NDCCode>
    <PackageDescription>480 mL in 1 BOTTLE, PLASTIC (10572-147-62)</PackageDescription>
    <NDC11Code>10572-0147-62</NDC11Code>
    <ProductNDC>10572-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nizatidine</ProprietaryName>
    <NonProprietaryName>Nizatidine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091218</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021494</ApplicationNumber>
    <LabelerName>Affordable Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>NIZATIDINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-03-06</LastUpdate>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>0406-0147-15</NDCCode><NonProprietaryName>P-aminophenol</NonProprietaryName></NDC><NDC><NDCCode>0406-0147-26</NDCCode><NonProprietaryName>P-aminophenol</NonProprietaryName></NDC><NDC><NDCCode>0245-0147-15</NDCCode><ProprietaryName>Pacerone</ProprietaryName><NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11523-0147-1</NDCCode><ProprietaryName>Afrin No Drip</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11673-147-15</NDCCode><ProprietaryName>Target Up And Up 2-in-1 Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzethonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>20276-147-15</NDCCode><ProprietaryName>Lucky</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>21695-147-15</NDCCode><ProprietaryName>Actos</ProprietaryName><NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>24909-147-15</NDCCode><ProprietaryName>Terrasil Ipl Relief</ProprietaryName><NonProprietaryName>Thuja Occidentalis</NonProprietaryName></NDC><NDC><NDCCode>33261-147-15</NDCCode><ProprietaryName>Benzonatate</ProprietaryName><NonProprietaryName>Benzonatate</NonProprietaryName></NDC><NDC><NDCCode>43353-147-15</NDCCode><ProprietaryName>Aripiprazole</ProprietaryName><NonProprietaryName>Aripiprazole</NonProprietaryName></NDC><NDC><NDCCode>43744-147-15</NDCCode><NonProprietaryName>Cefpodoxime Proxetil</NonProprietaryName></NDC><NDC><NDCCode>55289-147-15</NDCCode><ProprietaryName>Indomethacin</ProprietaryName><NonProprietaryName>Indomethacin</NonProprietaryName></NDC><NDC><NDCCode>67046-147-15</NDCCode><ProprietaryName>Divalproex Sodium</ProprietaryName><NonProprietaryName>Divalproex Sodium</NonProprietaryName></NDC><NDC><NDCCode>71630-147-15</NDCCode><ProprietaryName>Doterra Sun Face Daily Moisturizer</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0363-0406-15</NDCCode><ProprietaryName>Walgreens Pink Grapefruit Acne Wash</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>0406-0527-15</NDCCode><ProprietaryName>Methadose</ProprietaryName><NonProprietaryName>Methadone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0406-1516-42</NDCCode><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0406-2257-15</NDCCode><NonProprietaryName>Magnesium Stearate</NonProprietaryName></NDC><NDC><NDCCode>0406-8003-15</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0406-8725-15</NDCCode><ProprietaryName>Methadose</ProprietaryName><NonProprietaryName>Methadone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33342-406-15</NDCCode><ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43063-406-15</NDCCode><ProprietaryName>Hydroxyzine Pamoate</ProprietaryName><NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName></NDC><NDC><NDCCode>50268-406-15</NDCCode><ProprietaryName>Hydrocortisone</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>55289-406-15</NDCCode><ProprietaryName>Arthrotec</ProprietaryName><NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName></NDC><NDC><NDCCode>55319-406-15</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>63187-406-15</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>65197-406-15</NDCCode><ProprietaryName>Ad Medicated Rash</ProprietaryName><NonProprietaryName>Ad Medicated Rash</NonProprietaryName></NDC><NDC><NDCCode>66336-406-15</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>72789-406-15</NDCCode><ProprietaryName>Sildenafil Citrate</ProprietaryName><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>10572-147-62</NDCCode><ProprietaryName>Nizatidine</ProprietaryName><NonProprietaryName>Nizatidine</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",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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}
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