RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "83252-121-17",
      "PackageDescription": ".24 kg in 1 TUBE (83252-121-17) ",
      "NDC11Code": "83252-0121-17",
      "ProductNDC": "83252-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Zapper - Pure Zinc Sunscreen Spf50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250820",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Veganic SKN Limited",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2026-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20261007",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83252-122-17",
      "PackageDescription": ".24 kg in 1 TUBE (83252-122-17) ",
      "NDC11Code": "83252-0122-17",
      "ProductNDC": "83252-122",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Zapper - Pure Zinc Anti Mozzie Sunscreen Spf50",
      "NonProprietaryName": "Zinc Oxide Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250820",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "VEGANIC SKN LIMITED",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2026-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260723",
      "SamplePackage": "N",
      "IndicationAndUsage": "Please kindy refer to label."
    },
    {
      "NDCCode": "83252-121-03",
      "PackageDescription": ".1 kg in 1 TUBE (83252-121-03) ",
      "NDC11Code": "83252-0121-03",
      "ProductNDC": "83252-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Zapper - Pure Zinc Sunscreen Spf50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250820",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Veganic SKN Limited",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2026-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20261007",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83252-121-25",
      "PackageDescription": ".1 kg in 1 BOTTLE, PUMP (83252-121-25) ",
      "NDC11Code": "83252-0121-25",
      "ProductNDC": "83252-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Zapper - Pure Zinc Sunscreen Spf50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250820",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Veganic SKN Limited",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2026-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250820",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52920-121-17",
      "PackageDescription": "100 g in 1 JAR (52920-121-17)",
      "NDC11Code": "52920-0121-17",
      "ProductNDC": "52920-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pure Petroleum",
      "NonProprietaryName": "White Petroleum",
      "DosageFormName": "JELLY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100310",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Singhfam Corporation",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Uses. For the temporary protection of minor cuts, scrapes and burns. : 1 Helps relieve cracked or chapped lips and skin., 2 Helps to protect from the drying effects of wind and cold weather., 3 Helps reduce the appearance of fine dry lines., 4 May be used daily all over your body, face and hands."
    },
    {
      "NDCCode": "67777-121-18",
      "PackageDescription": "10 BOX in 1 CASE (67777-121-18)  / 100 POUCH in 1 BOX (67777-121-17)  / .7 mL in 1 POUCH (67777-121-16) ",
      "NDC11Code": "67777-0121-18",
      "ProductNDC": "67777-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Prep",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Dynarex Corporation",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100701",
      "SamplePackage": "N",
      "IndicationAndUsage": " First aid to help prevent infection in minor cuts, scrapes, and burns.  For preparation of the skin prior to an injection."
    },
    {
      "NDCCode": "75038-121-17",
      "PackageDescription": "1 BAG in 1 BOX (75038-121-17)  > 5 L in 1 BAG (75038-121-16) ",
      "NDC11Code": "75038-0121-17",
      "ProductNDC": "75038-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Multi-purpose Sanitiser",
      "NonProprietaryName": "Hypochlorous Acid Disinfectant",
      "DosageFormName": "LIQUID",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200415",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Guangdong Leaus Biotechnology Co., Ltd.",
      "SubstanceName": "HYPOCHLOROUS ACID",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/L",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200918",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83252-124-25",
      "PackageDescription": ".1 kg in 1 BOTTLE, PUMP (83252-124-25) ",
      "NDC11Code": "83252-0124-25",
      "ProductNDC": "83252-124",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Zapper - Acne Pure Zinc Sunscreen Spf50",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250916",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Veganic SKN Limited",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250916",
      "SamplePackage": "N",
      "IndicationAndUsage": "Please refer to the label."
    },
    {
      "NDCCode": "83252-126-25",
      "PackageDescription": ".1 kg in 1 BOTTLE, PUMP (83252-126-25) ",
      "NDC11Code": "83252-0126-25",
      "ProductNDC": "83252-126",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Zapper - Baby Pure Zinc Sunscreen Spf30",
      "NonProprietaryName": "Zinc Oxide Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250916",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "VEGANIC SKN LIMITED",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250916",
      "SamplePackage": "N",
      "IndicationAndUsage": "kindly refer to label picture."
    },
    {
      "NDCCode": "83252-128-25",
      "PackageDescription": ".1 kg in 1 BOTTLE, PUMP (83252-128-25) ",
      "NDC11Code": "83252-0128-25",
      "ProductNDC": "83252-128",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sun Zapper - Anti-ageing Pure Zinc Sunscreen Spf30",
      "NonProprietaryName": "Zinc Oxide Sunscreen",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250918",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "VEGANIC SKN LIMITED",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/100kg",
      "Status": "Active",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250918",
      "SamplePackage": "N",
      "IndicationAndUsage": "kindly refer to label picture."
    },
    {
      "NDCCode": "10122-121-02",
      "PackageDescription": "1 CANISTER in 1 CARTON (10122-121-02)  / 120 AEROSOL, METERED in 1 CANISTER",
      "NDC11Code": "10122-0121-02",
      "ProductNDC": "10122-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trimbow",
      "NonProprietaryName": "Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20260514",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA219622",
      "LabelerName": "Chiesi USA, Inc.",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE",
      "StrengthNumber": "172; 4.9; 10.6",
      "StrengthUnit": "ug/1; ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260714",
      "SamplePackage": "N",
      "IndicationAndUsage": "TRIMBOW is indicated for the maintenance treatment of asthma in adult patients aged 18 years and older. Limitations of Use. TRIMBOW is NOT indicated for relief of acute bronchospasm [see Warnings and Precautions (5.2)].",
      "Description": "TRIMBOW (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of beclomethasone dipropionate [an inhaled corticosteroid (ICS)], formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] and glycopyrrolate (an anticholinergic) for oral inhalation. Beclomethasone dipropionate, an inhaled corticosteroid [ICS], has the chemical name. [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate. Beclomethasone dipropionate is a white to creamy white, odorless powder, insoluble in water, freely soluble in acetone, and sparingly soluble in alcohol, with a molecular weight of 521.04218 g/mol, and the molecular formula is C28H37ClO7. The structural formula is as follows:. Formoterol fumarate, a long-acting β2 agonist has the chemical name (E)-but-2-enedioic acid; N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-formamide dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. Formoterol fumarate  has a molecular weight of 840.91 g/mol, and the molecular formula is C42H52N4O12. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S) . Glycopyrrolate is a quarternary ammonium bromide salt with the following chemical name: [RS-]-3-[(SR)-(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-Pyrrolidinium bromide. Two asymmetric atoms of carbon are present in the molecule: Glycopyrronium bromide is represented by the (R,S)-(S,R) racemic pair of enantiomers, corresponding to the threo diastereoisomeric structure. Glycopyrrolate is a powder that is freely soluble in water. Glycopyrrolate has a molecular weight of 398.33 g/mol, and the molecular formula is C19H28BrNO3. The structural formula is as follows. Glycopyrrolate contains two chiral centers and is a racemate of a 1;1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. TRIMBOW 86 mcg/4.9 mcg/10.6 mcg and TRIMBOW 172 mcg/4.9 mcg/10.6 mcg are formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized, metered-dose inhalers, each containing 120 actuations.  The canister is supplied with a grey plastic actuator with an integrated dose counter mechanism and mouthpiece, and a red cap (TRIMBOW 86 mcg/4.9 mcg/10.6 mcg) or a green cap (TRIMBOW 172 mcg/4.9 mcg/10.6 mcg). As a solution, TRIMBOW does not need to be shaken before use. TRIMBOW should be “primed” by actuating 2 times prior to using the first dose from a new canister. If the inhaler has not been used for 30 days or longer, re-prime the inhaler [see How Supplied/Storage and Handling (16)]. After priming, each actuation meters 100 or 200 mcg of beclomethasone dipropionate, 6.0 mcg of formoterol fumarate (equivalent to 5.7 mcg of formoterol fumarate anhydrous), and 12.5 mcg of glycopyrrolate (equivalent to 10 mcg of glycopyrronium) in 73.8 mg of solution from the valve and delivers 86 or 172 mcg of beclomethasone dipropionate, 4.9 mcg of formoterol fumarate (equivalent to 4.2 mcg of formoterol fumarate anhydrous), and 10.6 mcg of glycopyrrolate (equivalent to 8.5 mcg of glycopyrronium) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as coordination of the device (metered dose inhaler [MDI]) actuation with the inhalation maneuver, inspiratory flow and peak inspiratory flow through the delivery system, which may vary in patients with asthma and other pulmonary diseases and conditions. Avoid spraying in the eyes or face while using TRIMBOW. TRIMBOW contains dehydrated alcohol (18% v/v), HFA 134a, and hydrochloric acid as excipients in the formulation."
    },
    {
      "NDCCode": "10237-668-09",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-668-09)  > 121 g in 1 TUBE",
      "NDC11Code": "10237-0668-09",
      "ProductNDC": "10237-668",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Truly Radiant Clean And Fresh",
      "NonProprietaryName": "Sodium Monofluorophosphate 0.833%",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20151215",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": ".833",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20170510",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "16590-121-30",
      "PackageDescription": "1 TUBE in 1 CARTON (16590-121-30)  > 28.4 g in 1 TUBE",
      "NDC11Code": "16590-0121-30",
      "ProductNDC": "16590-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20020103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087795",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone is included in this class of synthetic corticosteroid. Chemically, hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)- its molecular formula is C21H30O5; its molecular weight is 362.46; its Chemical Abstract Service (CAS) registry number is 50-23-7; and its structural formula is. Each gram of Hydrocortisone Cream USP 1% provides 10 mg of hydrocortisone in a non-staining water washable cream base consisting of stearyl alcohol, glyceryl monostearate, polyoxyl 40 stearate, isopropyl palmitate, paraffin, sorbitan monostearate, glycerin, lactic acid, potassium sorbate and purified water. Each gram of Hydrocortisone Ointment USP 1% provides 10 mg of hydrocortisone in a white petrolatum base."
    },
    {
      "NDCCode": "21130-121-29",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (21130-121-29)  > 45 g in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "21130-0121-29",
      "ProductNDC": "21130-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Signature Care Miconazole 7",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20151103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074760",
      "LabelerName": "Safeway",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-17",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "IndicationAndUsage": "treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection."
    },
    {
      "NDCCode": "31722-121-01",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-121-01) ",
      "NDC11Code": "31722-0121-01",
      "ProductNDC": "31722-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200924",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212133",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-08-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 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 (5.1)], reserve opioid analgesics, including hydromorphone hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.",
      "Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
    },
    {
      "NDCCode": "42254-121-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (42254-121-90)",
      "NDC11Code": "42254-0121-90",
      "ProductNDC": "42254-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Etodolac",
      "NonProprietaryName": "Etodolac",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075078",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "ETODOLAC",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
      "Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C. 17. H. 21. NO. 3. , and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10)."
    },
    {
      "NDCCode": "43063-121-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-121-30) ",
      "NDC11Code": "43063-0121-30",
      "ProductNDC": "43063-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051006",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077091",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20091223",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1) ]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrys­talline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake)."
    },
    {
      "NDCCode": "43063-121-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43063-121-90) ",
      "NDC11Code": "43063-0121-90",
      "ProductNDC": "43063-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glimepiride",
      "NonProprietaryName": "Glimepiride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051006",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077091",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "GLIMEPIRIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20091223",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1) ]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
      "Description": "Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrys­talline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake)."
    },
    {
      "NDCCode": "46708-121-10",
      "PackageDescription": "100 CAPSULE in 1 CARTON (46708-121-10) ",
      "NDC11Code": "46708-0121-10",
      "ProductNDC": "46708-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190719",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203459",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2023-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190719",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "46708-121-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (46708-121-30) ",
      "NDC11Code": "46708-0121-30",
      "ProductNDC": "46708-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190719",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203459",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2023-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190719",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "46708-121-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (46708-121-90) ",
      "NDC11Code": "46708-0121-90",
      "ProductNDC": "46708-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190719",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203459",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2023-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190719",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "46708-121-91",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (46708-121-91) ",
      "NDC11Code": "46708-0121-91",
      "ProductNDC": "46708-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190719",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203459",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Active",
      "LastUpdate": "2023-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190719",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "51316-121-22",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (51316-121-22)  / 24 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "51316-0121-22",
      "ProductNDC": "51316-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sinus And Nasal Decongestant",
      "NonProprietaryName": "Pseudoephedrine Hcl",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250924",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
      "SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250924",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure."
    },
    {
      "NDCCode": "56104-258-01",
      "PackageDescription": "6 PATCH in 1 PACKAGE (56104-258-01) ",
      "NDC11Code": "56104-0258-01",
      "ProductNDC": "56104-258",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Salicylic Acid",
      "NonProprietaryName": "Clear Medicated Corn Removers",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220222",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M030",
      "LabelerName": "Premier Brands of America Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/121",
      "Status": "Active",
      "LastUpdate": "2026-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220222",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the removal of corns."
    },
    {
      "NDCCode": "57572-0725-1",
      "PackageDescription": "20 kg in 1 DRUM (57572-0725-1) ",
      "NDC11Code": "57572-0725-01",
      "ProductNDC": "57572-0725",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Vx-121",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240419",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Esteve Quimica SA",
      "SubstanceName": "VANZACAFTOR CALCIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-17",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19-APR-24"
    },
    {
      "NDCCode": "58232-0027-1",
      "PackageDescription": "1 CANISTER in 1 CARTON (58232-0027-1)  > 75 mL in 1 CANISTER",
      "NDC11Code": "58232-0027-01",
      "ProductNDC": "58232-0027",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aveeno Active Naturals Positively Ageless Youth Perfecting Moisturizer",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100115",
      "EndMarketingDate": "20150524",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "30.3; 121.2; 50.5; 17.2; 30.3",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-05-29"
    },
    {
      "NDCCode": "59469-121-10",
      "PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-121-10)  > 50 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "59469-0121-10",
      "ProductNDC": "59469-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Akutur",
      "NonProprietaryName": "Benzoic Acid, Nitric Acid, Apis Mellifera, Lytta Vesicatoria, Populus Tremuloides Bark, Anemone Pratensis Flowering Top, Ginger, And Solidago Virgaurea Flowering Top",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081211",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "PEKANA Nautrheilmittel GmbH",
      "SubstanceName": "BENZOIC ACID; NITRIC ACID; APIS MELLIFERA; LYTTA VESICATORIA; POPULUS TREMULOIDES BARK; ANEMONE PRATENSIS FLOWERING TOP; GINGER; SOLIDAGO VIRGAUREA FLOWERING TOP",
      "StrengthNumber": "4; 4; 3; 4; 2; 4; 3; 2208",
      "StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20081211",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61726-121-00",
      "PackageDescription": "600 g in 1 JAR (61726-121-00) ",
      "NDC11Code": "61726-0121-00",
      "ProductNDC": "61726-121",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "PASTE",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "MakingCosmetics Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2024-01-17",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-MAY-23"
    },
    {
      "NDCCode": "62207-121-13",
      "PackageDescription": "50000000 mg in 1 DRUM (62207-121-13) ",
      "NDC11Code": "62207-0121-13",
      "ProductNDC": "62207-121",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Compresso Pap 90 F",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170929",
      "MarketingCategoryName": "EXPORT ONLY",
      "LabelerName": "Granules India Limited",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "90",
      "StrengthUnit": "mg/90mg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "29-SEP-17"
    },
    {
      "NDCCode": "65862-121-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-121-05) ",
      "NDC11Code": "65862-0121-05",
      "ProductNDC": "65862-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Risperidone",
      "NonProprietaryName": "Risperidone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078269",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "RISPERIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20081008",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"83252-121-17","ProprietaryName":"Sun Zapper - Pure Zinc Sunscreen Spf50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"83252-122-17","ProprietaryName":"Sun Zapper - Pure Zinc Anti Mozzie Sunscreen Spf50","NonProprietaryName":"Zinc Oxide Sunscreen"},{"NDCCode":"83252-121-03","ProprietaryName":"Sun Zapper - Pure Zinc Sunscreen Spf50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"83252-121-25","ProprietaryName":"Sun Zapper - Pure Zinc Sunscreen Spf50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"52920-121-17","ProprietaryName":"Pure Petroleum","NonProprietaryName":"White Petroleum"},{"NDCCode":"67777-121-18","ProprietaryName":"Alcohol Prep","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"75038-121-17","ProprietaryName":"Multi-purpose Sanitiser","NonProprietaryName":"Hypochlorous Acid Disinfectant"},{"NDCCode":"83252-124-25","ProprietaryName":"Sun Zapper - Acne Pure Zinc Sunscreen Spf50","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"83252-126-25","ProprietaryName":"Sun Zapper - Baby Pure Zinc Sunscreen Spf30","NonProprietaryName":"Zinc Oxide Sunscreen"},{"NDCCode":"83252-128-25","ProprietaryName":"Sun Zapper - Anti-ageing Pure Zinc Sunscreen Spf30","NonProprietaryName":"Zinc Oxide Sunscreen"},{"NDCCode":"10122-121-02","ProprietaryName":"Trimbow","NonProprietaryName":"Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate"},{"NDCCode":"10237-668-09","ProprietaryName":"Truly Radiant Clean And Fresh","NonProprietaryName":"Sodium Monofluorophosphate 0.833%"},{"NDCCode":"16590-121-30","ProprietaryName":"Hydrocortisone","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"21130-121-29","ProprietaryName":"Signature Care Miconazole 7","NonProprietaryName":"Miconazole Nitrate"},{"NDCCode":"31722-121-01","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"42254-121-90","ProprietaryName":"Etodolac","NonProprietaryName":"Etodolac"},{"NDCCode":"43063-121-30","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"43063-121-90","ProprietaryName":"Glimepiride","NonProprietaryName":"Glimepiride"},{"NDCCode":"46708-121-10","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"46708-121-30","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"46708-121-90","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"46708-121-91","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"51316-121-22","ProprietaryName":"Sinus And Nasal Decongestant","NonProprietaryName":"Pseudoephedrine Hcl"},{"NDCCode":"56104-258-01","ProprietaryName":"Salicylic Acid","NonProprietaryName":"Clear Medicated Corn Removers"},{"NDCCode":"57572-0725-1","NonProprietaryName":"Vx-121"},{"NDCCode":"58232-0027-1","ProprietaryName":"Aveeno Active Naturals Positively Ageless Youth Perfecting Moisturizer","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone"},{"NDCCode":"59469-121-10","ProprietaryName":"Akutur","NonProprietaryName":"Benzoic Acid, Nitric Acid, Apis Mellifera, Lytta Vesicatoria, Populus Tremuloides Bark, Anemone Pratensis Flowering Top, Ginger, And Solidago Virgaurea Flowering Top"},{"NDCCode":"61726-121-00","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"62207-121-13","NonProprietaryName":"Compresso Pap 90 F"},{"NDCCode":"65862-121-05","ProprietaryName":"Risperidone","NonProprietaryName":"Risperidone"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>83252-121-17</NDCCode>
    <PackageDescription>.24 kg in 1 TUBE (83252-121-17) </PackageDescription>
    <NDC11Code>83252-0121-17</NDC11Code>
    <ProductNDC>83252-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Zapper - Pure Zinc Sunscreen Spf50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Veganic SKN Limited</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83252-122-17</NDCCode>
    <PackageDescription>.24 kg in 1 TUBE (83252-122-17) </PackageDescription>
    <NDC11Code>83252-0122-17</NDC11Code>
    <ProductNDC>83252-122</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Zapper - Pure Zinc Anti Mozzie Sunscreen Spf50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>VEGANIC SKN LIMITED</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Please kindy refer to label.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83252-121-03</NDCCode>
    <PackageDescription>.1 kg in 1 TUBE (83252-121-03) </PackageDescription>
    <NDC11Code>83252-0121-03</NDC11Code>
    <ProductNDC>83252-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Zapper - Pure Zinc Sunscreen Spf50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Veganic SKN Limited</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83252-121-25</NDCCode>
    <PackageDescription>.1 kg in 1 BOTTLE, PUMP (83252-121-25) </PackageDescription>
    <NDC11Code>83252-0121-25</NDC11Code>
    <ProductNDC>83252-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Zapper - Pure Zinc Sunscreen Spf50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Veganic SKN Limited</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52920-121-17</NDCCode>
    <PackageDescription>100 g in 1 JAR (52920-121-17)</PackageDescription>
    <NDC11Code>52920-0121-17</NDC11Code>
    <ProductNDC>52920-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pure Petroleum</ProprietaryName>
    <NonProprietaryName>White Petroleum</NonProprietaryName>
    <DosageFormName>JELLY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100310</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Singhfam Corporation</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. For the temporary protection of minor cuts, scrapes and burns. : 1 Helps relieve cracked or chapped lips and skin., 2 Helps to protect from the drying effects of wind and cold weather., 3 Helps reduce the appearance of fine dry lines., 4 May be used daily all over your body, face and hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67777-121-18</NDCCode>
    <PackageDescription>10 BOX in 1 CASE (67777-121-18)  / 100 POUCH in 1 BOX (67777-121-17)  / .7 mL in 1 POUCH (67777-121-16) </PackageDescription>
    <NDC11Code>67777-0121-18</NDC11Code>
    <ProductNDC>67777-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Prep</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>Dynarex Corporation</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> First aid to help prevent infection in minor cuts, scrapes, and burns.  For preparation of the skin prior to an injection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75038-121-17</NDCCode>
    <PackageDescription>1 BAG in 1 BOX (75038-121-17)  &gt; 5 L in 1 BAG (75038-121-16) </PackageDescription>
    <NDC11Code>75038-0121-17</NDC11Code>
    <ProductNDC>75038-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Multi-purpose Sanitiser</ProprietaryName>
    <NonProprietaryName>Hypochlorous Acid Disinfectant</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>EXTRACORPOREAL</RouteName>
    <StartMarketingDate>20200415</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Guangdong Leaus Biotechnology Co., Ltd.</LabelerName>
    <SubstanceName>HYPOCHLOROUS ACID</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83252-124-25</NDCCode>
    <PackageDescription>.1 kg in 1 BOTTLE, PUMP (83252-124-25) </PackageDescription>
    <NDC11Code>83252-0124-25</NDC11Code>
    <ProductNDC>83252-124</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Zapper - Acne Pure Zinc Sunscreen Spf50</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Veganic SKN Limited</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Please refer to the label.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83252-126-25</NDCCode>
    <PackageDescription>.1 kg in 1 BOTTLE, PUMP (83252-126-25) </PackageDescription>
    <NDC11Code>83252-0126-25</NDC11Code>
    <ProductNDC>83252-126</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Zapper - Baby Pure Zinc Sunscreen Spf30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250916</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>VEGANIC SKN LIMITED</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>kindly refer to label picture.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83252-128-25</NDCCode>
    <PackageDescription>.1 kg in 1 BOTTLE, PUMP (83252-128-25) </PackageDescription>
    <NDC11Code>83252-0128-25</NDC11Code>
    <ProductNDC>83252-128</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sun Zapper - Anti-ageing Pure Zinc Sunscreen Spf30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide Sunscreen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250918</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>VEGANIC SKN LIMITED</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>kindly refer to label picture.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10122-121-02</NDCCode>
    <PackageDescription>1 CANISTER in 1 CARTON (10122-121-02)  / 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
    <NDC11Code>10122-0121-02</NDC11Code>
    <ProductNDC>10122-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trimbow</ProprietaryName>
    <NonProprietaryName>Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20260514</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219622</ApplicationNumber>
    <LabelerName>Chiesi USA, Inc.</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>172; 4.9; 10.6</StrengthNumber>
    <StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TRIMBOW is indicated for the maintenance treatment of asthma in adult patients aged 18 years and older. Limitations of Use. TRIMBOW is NOT indicated for relief of acute bronchospasm [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>TRIMBOW (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of beclomethasone dipropionate [an inhaled corticosteroid (ICS)], formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] and glycopyrrolate (an anticholinergic) for oral inhalation. Beclomethasone dipropionate, an inhaled corticosteroid [ICS], has the chemical name. [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate. Beclomethasone dipropionate is a white to creamy white, odorless powder, insoluble in water, freely soluble in acetone, and sparingly soluble in alcohol, with a molecular weight of 521.04218 g/mol, and the molecular formula is C28H37ClO7. The structural formula is as follows:. Formoterol fumarate, a long-acting β2 agonist has the chemical name (E)-but-2-enedioic acid; N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-formamide dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. Formoterol fumarate  has a molecular weight of 840.91 g/mol, and the molecular formula is C42H52N4O12. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S) . Glycopyrrolate is a quarternary ammonium bromide salt with the following chemical name: [RS-]-3-[(SR)-(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-Pyrrolidinium bromide. Two asymmetric atoms of carbon are present in the molecule: Glycopyrronium bromide is represented by the (R,S)-(S,R) racemic pair of enantiomers, corresponding to the threo diastereoisomeric structure. Glycopyrrolate is a powder that is freely soluble in water. Glycopyrrolate has a molecular weight of 398.33 g/mol, and the molecular formula is C19H28BrNO3. The structural formula is as follows. Glycopyrrolate contains two chiral centers and is a racemate of a 1;1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. TRIMBOW 86 mcg/4.9 mcg/10.6 mcg and TRIMBOW 172 mcg/4.9 mcg/10.6 mcg are formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized, metered-dose inhalers, each containing 120 actuations.  The canister is supplied with a grey plastic actuator with an integrated dose counter mechanism and mouthpiece, and a red cap (TRIMBOW 86 mcg/4.9 mcg/10.6 mcg) or a green cap (TRIMBOW 172 mcg/4.9 mcg/10.6 mcg). As a solution, TRIMBOW does not need to be shaken before use. TRIMBOW should be “primed” by actuating 2 times prior to using the first dose from a new canister. If the inhaler has not been used for 30 days or longer, re-prime the inhaler [see How Supplied/Storage and Handling (16)]. After priming, each actuation meters 100 or 200 mcg of beclomethasone dipropionate, 6.0 mcg of formoterol fumarate (equivalent to 5.7 mcg of formoterol fumarate anhydrous), and 12.5 mcg of glycopyrrolate (equivalent to 10 mcg of glycopyrronium) in 73.8 mg of solution from the valve and delivers 86 or 172 mcg of beclomethasone dipropionate, 4.9 mcg of formoterol fumarate (equivalent to 4.2 mcg of formoterol fumarate anhydrous), and 10.6 mcg of glycopyrrolate (equivalent to 8.5 mcg of glycopyrronium) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as coordination of the device (metered dose inhaler [MDI]) actuation with the inhalation maneuver, inspiratory flow and peak inspiratory flow through the delivery system, which may vary in patients with asthma and other pulmonary diseases and conditions. Avoid spraying in the eyes or face while using TRIMBOW. TRIMBOW contains dehydrated alcohol (18% v/v), HFA 134a, and hydrochloric acid as excipients in the formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>10237-668-09</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-668-09)  &gt; 121 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0668-09</NDC11Code>
    <ProductNDC>10237-668</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Truly Radiant Clean And Fresh</ProprietaryName>
    <NonProprietaryName>Sodium Monofluorophosphate 0.833%</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20151215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
    <StrengthNumber>.833</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>16590-121-30</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16590-121-30)  &gt; 28.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>16590-0121-30</NDC11Code>
    <ProductNDC>16590-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087795</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone is included in this class of synthetic corticosteroid. Chemically, hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)- its molecular formula is C21H30O5; its molecular weight is 362.46; its Chemical Abstract Service (CAS) registry number is 50-23-7; and its structural formula is. Each gram of Hydrocortisone Cream USP 1% provides 10 mg of hydrocortisone in a non-staining water washable cream base consisting of stearyl alcohol, glyceryl monostearate, polyoxyl 40 stearate, isopropyl palmitate, paraffin, sorbitan monostearate, glycerin, lactic acid, potassium sorbate and purified water. Each gram of Hydrocortisone Ointment USP 1% provides 10 mg of hydrocortisone in a white petrolatum base.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-121-29</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (21130-121-29)  &gt; 45 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>21130-0121-29</NDC11Code>
    <ProductNDC>21130-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Signature Care Miconazole 7</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20151103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074760</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-121-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-121-01) </PackageDescription>
    <NDC11Code>31722-0121-01</NDC11Code>
    <ProductNDC>31722-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212133</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-08-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 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 (5.1)], reserve opioid analgesics, including hydromorphone hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>42254-121-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (42254-121-90)</PackageDescription>
    <NDC11Code>42254-0121-90</NDC11Code>
    <ProductNDC>42254-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Etodolac</ProprietaryName>
    <NonProprietaryName>Etodolac</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075078</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>ETODOLAC</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
    <Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C. 17. H. 21. NO. 3. , and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10).</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-121-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-121-30) </PackageDescription>
    <NDC11Code>43063-0121-30</NDC11Code>
    <ProductNDC>43063-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glimepiride</ProprietaryName>
    <NonProprietaryName>Glimepiride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077091</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GLIMEPIRIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1) ]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
    <Description>Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrys­talline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&amp;C yellow # 10 aluminium lake and FD&amp;C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&amp;C yellow # 10 aluminium lake and FD&amp;C blue # 1/ brilliant blue FCF aluminium lake).</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-121-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43063-121-90) </PackageDescription>
    <NDC11Code>43063-0121-90</NDC11Code>
    <ProductNDC>43063-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glimepiride</ProprietaryName>
    <NonProprietaryName>Glimepiride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077091</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GLIMEPIRIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1) ]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
    <Description>Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrys­talline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&amp;C yellow # 10 aluminium lake and FD&amp;C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&amp;C yellow # 10 aluminium lake and FD&amp;C blue # 1/ brilliant blue FCF aluminium lake).</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-121-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 CARTON (46708-121-10) </PackageDescription>
    <NDC11Code>46708-0121-10</NDC11Code>
    <ProductNDC>46708-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203459</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-121-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (46708-121-30) </PackageDescription>
    <NDC11Code>46708-0121-30</NDC11Code>
    <ProductNDC>46708-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203459</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-121-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (46708-121-90) </PackageDescription>
    <NDC11Code>46708-0121-90</NDC11Code>
    <ProductNDC>46708-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203459</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-121-91</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (46708-121-91) </PackageDescription>
    <NDC11Code>46708-0121-91</NDC11Code>
    <ProductNDC>46708-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203459</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy  Management of postherpetic neuralgia  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older  Management of fibromyalgia  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products.  However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>51316-121-22</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (51316-121-22)  / 24 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51316-0121-22</NDC11Code>
    <ProductNDC>51316-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sinus And Nasal Decongestant</ProprietaryName>
    <NonProprietaryName>Pseudoephedrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250924</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
    <SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>56104-258-01</NDCCode>
    <PackageDescription>6 PATCH in 1 PACKAGE (56104-258-01) </PackageDescription>
    <NDC11Code>56104-0258-01</NDC11Code>
    <ProductNDC>56104-258</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Salicylic Acid</ProprietaryName>
    <NonProprietaryName>Clear Medicated Corn Removers</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M030</ApplicationNumber>
    <LabelerName>Premier Brands of America Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/121</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the removal of corns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57572-0725-1</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (57572-0725-1) </PackageDescription>
    <NDC11Code>57572-0725-01</NDC11Code>
    <ProductNDC>57572-0725</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Vx-121</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240419</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Esteve Quimica SA</LabelerName>
    <SubstanceName>VANZACAFTOR CALCIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19-APR-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>58232-0027-1</NDCCode>
    <PackageDescription>1 CANISTER in 1 CARTON (58232-0027-1)  &gt; 75 mL in 1 CANISTER</PackageDescription>
    <NDC11Code>58232-0027-01</NDC11Code>
    <ProductNDC>58232-0027</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aveeno Active Naturals Positively Ageless Youth Perfecting Moisturizer</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100115</StartMarketingDate>
    <EndMarketingDate>20150524</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Products Company, Division of Johnson &amp; Johnson Consumer Companies, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>30.3; 121.2; 50.5; 17.2; 30.3</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-05-29</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>59469-121-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-121-10)  &gt; 50 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>59469-0121-10</NDC11Code>
    <ProductNDC>59469-121</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Akutur</ProprietaryName>
    <NonProprietaryName>Benzoic Acid, Nitric Acid, Apis Mellifera, Lytta Vesicatoria, Populus Tremuloides Bark, Anemone Pratensis Flowering Top, Ginger, And Solidago Virgaurea Flowering Top</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081211</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>PEKANA Nautrheilmittel GmbH</LabelerName>
    <SubstanceName>BENZOIC ACID; NITRIC ACID; APIS MELLIFERA; LYTTA VESICATORIA; POPULUS TREMULOIDES BARK; ANEMONE PRATENSIS FLOWERING TOP; GINGER; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
    <StrengthNumber>4; 4; 3; 4; 2; 4; 3; 2208</StrengthNumber>
    <StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61726-121-00</NDCCode>
    <PackageDescription>600 g in 1 JAR (61726-121-00) </PackageDescription>
    <NDC11Code>61726-0121-00</NDC11Code>
    <ProductNDC>61726-121</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <StartMarketingDate>20230501</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>MakingCosmetics Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-01-17</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAY-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>62207-121-13</NDCCode>
    <PackageDescription>50000000 mg in 1 DRUM (62207-121-13) </PackageDescription>
    <NDC11Code>62207-0121-13</NDC11Code>
    <ProductNDC>62207-121</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Compresso Pap 90 F</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170929</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/90mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-SEP-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65862-121-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65862-121-05) </PackageDescription>
    <NDC11Code>65862-0121-05</NDC11Code>
    <ProductNDC>65862-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078269</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20081008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>83252-121-17</NDCCode><ProprietaryName>Sun Zapper - Pure Zinc Sunscreen Spf50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>83252-122-17</NDCCode><ProprietaryName>Sun Zapper - Pure Zinc Anti Mozzie Sunscreen Spf50</ProprietaryName><NonProprietaryName>Zinc Oxide Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>83252-121-03</NDCCode><ProprietaryName>Sun Zapper - Pure Zinc Sunscreen Spf50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>83252-121-25</NDCCode><ProprietaryName>Sun Zapper - Pure Zinc Sunscreen Spf50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>52920-121-17</NDCCode><ProprietaryName>Pure Petroleum</ProprietaryName><NonProprietaryName>White Petroleum</NonProprietaryName></NDC><NDC><NDCCode>67777-121-18</NDCCode><ProprietaryName>Alcohol Prep</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75038-121-17</NDCCode><ProprietaryName>Multi-purpose Sanitiser</ProprietaryName><NonProprietaryName>Hypochlorous Acid Disinfectant</NonProprietaryName></NDC><NDC><NDCCode>83252-124-25</NDCCode><ProprietaryName>Sun Zapper - Acne Pure Zinc Sunscreen Spf50</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>83252-126-25</NDCCode><ProprietaryName>Sun Zapper - Baby Pure Zinc Sunscreen Spf30</ProprietaryName><NonProprietaryName>Zinc Oxide Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>83252-128-25</NDCCode><ProprietaryName>Sun Zapper - Anti-ageing Pure Zinc Sunscreen Spf30</ProprietaryName><NonProprietaryName>Zinc Oxide Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>10122-121-02</NDCCode><ProprietaryName>Trimbow</ProprietaryName><NonProprietaryName>Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>10237-668-09</NDCCode><ProprietaryName>Truly Radiant Clean And Fresh</ProprietaryName><NonProprietaryName>Sodium Monofluorophosphate 0.833%</NonProprietaryName></NDC><NDC><NDCCode>16590-121-30</NDCCode><ProprietaryName>Hydrocortisone</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>21130-121-29</NDCCode><ProprietaryName>Signature Care Miconazole 7</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>31722-121-01</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42254-121-90</NDCCode><ProprietaryName>Etodolac</ProprietaryName><NonProprietaryName>Etodolac</NonProprietaryName></NDC><NDC><NDCCode>43063-121-30</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>43063-121-90</NDCCode><ProprietaryName>Glimepiride</ProprietaryName><NonProprietaryName>Glimepiride</NonProprietaryName></NDC><NDC><NDCCode>46708-121-10</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>46708-121-30</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>46708-121-90</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>46708-121-91</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>51316-121-22</NDCCode><ProprietaryName>Sinus And Nasal Decongestant</ProprietaryName><NonProprietaryName>Pseudoephedrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>56104-258-01</NDCCode><ProprietaryName>Salicylic Acid</ProprietaryName><NonProprietaryName>Clear Medicated Corn Removers</NonProprietaryName></NDC><NDC><NDCCode>57572-0725-1</NDCCode><NonProprietaryName>Vx-121</NonProprietaryName></NDC><NDC><NDCCode>58232-0027-1</NDCCode><ProprietaryName>Aveeno Active Naturals Positively Ageless Youth Perfecting Moisturizer</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>59469-121-10</NDCCode><ProprietaryName>Akutur</ProprietaryName><NonProprietaryName>Benzoic Acid, Nitric Acid, Apis Mellifera, Lytta Vesicatoria, Populus Tremuloides Bark, Anemone Pratensis Flowering Top, Ginger, And Solidago Virgaurea Flowering Top</NonProprietaryName></NDC><NDC><NDCCode>61726-121-00</NDCCode><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>62207-121-13</NDCCode><NonProprietaryName>Compresso Pap 90 F</NonProprietaryName></NDC><NDC><NDCCode>65862-121-05</NDCCode><ProprietaryName>Risperidone</ProprietaryName><NonProprietaryName>Risperidone</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.

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();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
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      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

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