RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (31 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "10237-719-15",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-719-15)  > 42 g in 1 TUBE",
      "NDC11Code": "10237-0719-15",
      "ProductNDC": "10237-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Orajel Dry Mouth Moistruizing",
      "NonProprietaryName": "Glycerin",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100721",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "GLYCERIN",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "43353-719-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (43353-719-15)",
      "NDC11Code": "43353-0719-15",
      "ProductNDC": "43353-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19730112",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA083177",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2017-10-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
      "Description": "Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate."
    },
    {
      "NDCCode": "50809-001-08",
      "PackageDescription": "719.15 L in 1 DEWAR (50809-001-08) ",
      "NDC11Code": "50809-0001-08",
      "ProductNDC": "50809-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20100517",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Abilene Oxygen Inc.",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "99",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20100517",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55289-719-15",
      "PackageDescription": "15 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-719-15) ",
      "NDC11Code": "55289-0719-15",
      "ProductNDC": "55289-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076003",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20140715",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58160-894-15",
      "PackageDescription": "1 KIT in 1 CARTON (58160-894-15)  *  .5 mL in 1 VIAL (58160-719-03)  *  .5 mL in 1 SYRINGE (58160-749-07) ",
      "NDC11Code": "58160-0894-15",
      "ProductNDC": "58160-894",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Arexvy",
      "NonProprietaryName": "Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20260430",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125775",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Active",
      "LastUpdate": "2026-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
      "Description": "AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex."
    },
    {
      "NDCCode": "60760-719-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (60760-719-15) ",
      "NDC11Code": "60760-0719-15",
      "ProductNDC": "60760-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tizanidine",
      "NonProprietaryName": "Tizanidine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210727",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076416",
      "LabelerName": "St. Mary's Medical Park Pharmacy",
      "SubstanceName": "TIZANIDINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210929",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1)].",
      "Description": "Tizanidine Tablets, USP  (tizanidine hydrochloride) is a central alpha 2-adrenergic agonist. Tizanidine HCl is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine's molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is: Tizanidine Tablets, USP are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine Tablets, USP contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base and  4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose, lactose monohydrate and anhydrous lactose."
    },
    {
      "NDCCode": "63187-719-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (63187-719-15) ",
      "NDC11Code": "63187-0719-15",
      "ProductNDC": "63187-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160309",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202677",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2019-11-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.",
      "Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 5 mg*Acetaminophen, USP 325 mg*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. All strengths of Oxycodone and Acetaminophen Tablets also contain the following inactive ingredients: Pregelatinized cornstarch, povidone, lactose monohydrate, crospovidone, and stearic acid. In addition, the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "71919-719-07",
      "PackageDescription": "15 mL in 1 VIAL, GLASS (71919-719-07) ",
      "NDC11Code": "71919-0719-07",
      "ProductNDC": "71919-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Wyethia Helenioides",
      "NonProprietaryName": "Wyethia Helenioides",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110517",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "WYETHIA HELENIOIDES ROOT",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110517",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84756-719-02",
      "PackageDescription": "15 mL in 1 BOTTLE (84756-719-02) ",
      "NDC11Code": "84756-0719-02",
      "ProductNDC": "84756-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Beard Oil",
      "NonProprietaryName": "Beard Oil",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241212",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "10237-463-15",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10237-463-15)  / 15 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "10237-0463-15",
      "ProductNDC": "10237-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zicam Allergy Relief",
      "NonProprietaryName": "Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20211001",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR",
      "StrengthNumber": "30; 200; 30; 200",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Active",
      "LastUpdate": "2024-11-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Effective Relief of Allergy Symptoms: runny noseitchy nosewatery eyessneezing."
    },
    {
      "NDCCode": "10237-464-15",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10237-464-15)  / 15 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "10237-0464-15",
      "ProductNDC": "10237-464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zicam Extreme Congestion Relief",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20211001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211001",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves nasal congestion due to: the common coldhay feverupper respiratory allergies. temporarily relieves sinus congestion and pressure. helps clear nasal passages. shrinks swollen membranes."
    },
    {
      "NDCCode": "10237-471-15",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10237-471-15)  / 15 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "10237-0471-15",
      "ProductNDC": "10237-471",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zicam Intense Sinus Relief",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20220228",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220228",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves nasal congestion due to: the common coldhay feverupper respiratory allergies. temporarily relieves sinus congestion and pressure. helps clear nasal passages. shrinks swollen membranes."
    },
    {
      "NDCCode": "10237-474-15",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10237-474-15)  / 15 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "10237-0474-15",
      "ProductNDC": "10237-474",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zicam Cold Remedy",
      "NonProprietaryName": "Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20220410",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED",
      "StrengthNumber": "4; 4; 4",
      "StrengthUnit": "[hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL",
      "Status": "Active",
      "LastUpdate": "2024-11-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220410",
      "SamplePackage": "N",
      "IndicationAndUsage": "Reduces duration of the common cold and helps relieve nasal congestion. ---------------------------------------------------------------------------------------------------. Zicam ® Cold Remedy was not formulated to be effective for flu or allergies."
    },
    {
      "NDCCode": "10237-591-15",
      "PackageDescription": "680000 g in 1 BAG (10237-591-15) ",
      "NDC11Code": "10237-0591-15",
      "ProductNDC": "10237-591",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arm And Hammer Baking Soda",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180202",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10237-696-15",
      "PackageDescription": "45 mL in 1 CAN (10237-696-15)",
      "NDC11Code": "10237-0696-15",
      "ProductNDC": "10237-696",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Simple Saline Plus Childrens",
      "ProprietaryNameSuffix": "Cold Formula Plus Moisturizers",
      "NonProprietaryName": "Luffa Operculata, Sabadilla",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20110512",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED",
      "StrengthNumber": "6; 6",
      "StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "according to homeopathic principles, the active ingredients in this medication temporarily relieve symptoms of: 1 nasal congestion, 2 runny nose due to colds and flu, 3 post-nasal drip, 4 dry, irritated nasal passages, 5 sinus congestion and pressure."
    },
    {
      "NDCCode": "10237-755-12",
      "PackageDescription": "12 APPLICATOR in 1 CARTON (10237-755-12)  > .15 g in 1 APPLICATOR",
      "NDC11Code": "10237-0755-12",
      "ProductNDC": "10237-755",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Orajel Instant Pain Relief",
      "ProprietaryNameSuffix": "Maximum",
      "NonProprietaryName": "Benzocaine 20%",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100811",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100811",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10237-774-15",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (10237-774-15)  / 15 g in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0774-15",
      "ProductNDC": "10237-774",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rephresh Cooling",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180601",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "500",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180601",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of external feminine itching. Other uses of this product should be only under the advice and supervision of a doctor."
    },
    {
      "NDCCode": "11822-0678-1",
      "PackageDescription": "1 TUBE in 1 CARTON (11822-0678-1)  > 57 g in 1 TUBE",
      "NDC11Code": "11822-0678-01",
      "ProductNDC": "11822-0678",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hemorrhoid Relief",
      "NonProprietaryName": "Mineral Oil, Petrolatum, Phenylephrine Hcl",
      "DosageFormName": "OINTMENT",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20121012",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part346",
      "LabelerName": "Rite Aid Corporation",
      "SubstanceName": "MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "140; 719; 2.5",
      "StrengthUnit": "mg/100g; mg/100g; mg/100g",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-15"
    },
    {
      "NDCCode": "42507-719-08",
      "PackageDescription": "222 mL in 1 BOTTLE, PLASTIC (42507-719-08)",
      "NDC11Code": "42507-0719-08",
      "ProductNDC": "42507-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Le Techniq",
      "ProprietaryNameSuffix": "Morning Mist Antibacterial Hand",
      "NonProprietaryName": "Triclosan",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140225",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "HYVEE INC",
      "SubstanceName": "TRICLOSAN",
      "StrengthNumber": "1.15",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "HELPS REDUCE BACTERIA ON THE SKIN."
    },
    {
      "NDCCode": "49281-719-10",
      "PackageDescription": "10 SYRINGE in 1 CARTON (49281-719-10)  > .5 mL in 1 SYRINGE (49281-719-88) ",
      "NDC11Code": "49281-0719-10",
      "ProductNDC": "49281-719",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flublok Quadrivalent",
      "NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/kansas/14/2017 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125285",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN",
      "StrengthNumber": "45; 45; 45; 45",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49527-719-01",
      "PackageDescription": "1 JAR in 1 CARTON (49527-719-01)  > 50 mL in 1 JAR (49527-719-02)",
      "NDC11Code": "49527-0719-01",
      "ProductNDC": "49527-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Repairwear Lift",
      "ProprietaryNameSuffix": "Spf 15 Firming Day Dry Combo Skin",
      "NonProprietaryName": "Octinoxate, Octisalate, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20070401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CLINIQUE LABORATORIES INC",
      "SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "7.5; 3.5; 1",
      "StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "50580-719-12",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (50580-719-12)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "50580-0719-12",
      "ProductNDC": "50580-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zyrtec-d",
      "NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021150",
      "LabelerName": "Kenvue Brands LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230228",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "50580-719-24",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (50580-719-24)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "50580-0719-24",
      "ProductNDC": "50580-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zyrtec-d",
      "NonProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021150",
      "LabelerName": "Kenvue Brands LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230228",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "52584-719-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (52584-719-01)  > 1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "52584-0719-01",
      "ProductNDC": "52584-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20210714",
      "EndMarketingDate": "20231031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204216",
      "LabelerName": "General Injectables and Vaccines, Inc.",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210714",
      "EndMarketingDatePackage": "20231031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55111-719-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-719-05) ",
      "NDC11Code": "55111-0719-05",
      "ProductNDC": "55111-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202383",
      "LabelerName": "Dr.Reddy's Laboratories Limited",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130620",
      "SamplePackage": "N",
      "Description": "Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "55111-719-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-719-30) ",
      "NDC11Code": "55111-0719-30",
      "ProductNDC": "55111-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202383",
      "LabelerName": "Dr.Reddy's Laboratories Limited",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130620",
      "SamplePackage": "N",
      "Description": "Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "59158-719-01",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (59158-719-01)  > 50 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "59158-0719-01",
      "ProductNDC": "59158-719",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All You Need",
      "ProprietaryNameSuffix": "Continuous Action 24 Hour Moisture Spf 15 For Normal Skin",
      "NonProprietaryName": "Homosalate, Octinoxate, Avobenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20071201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "PRESCRIPTIVES INC.",
      "SubstanceName": "HOMOSALATE; OCTINOXATE; AVOBENZONE",
      "StrengthNumber": "5; 5; 3",
      "StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "67877-719-31",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (67877-719-31)  / 10 TABLET in 1 BLISTER PACK (67877-719-33) ",
      "NDC11Code": "67877-0719-31",
      "ProductNDC": "67877-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Everolimus",
      "NonProprietaryName": "Everolimus",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214138",
      "LabelerName": "Ascend Laboratories, LLC",
      "SubstanceName": "EVEROLIMUS",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:  Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1)  Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use:  Safety and efficacy have not been established in the following:  Kidney transplant patients at high immunologic risk (1.3)  Recipients of transplanted organs other than kidney or liver (1.3, 5.7)  Pediatric patients (less than 18 years) (1.3).",
      "Description": "Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)­ 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36­ dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients."
    },
    {
      "NDCCode": "67877-719-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (67877-719-60) ",
      "NDC11Code": "67877-0719-60",
      "ProductNDC": "67877-719",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Everolimus",
      "NonProprietaryName": "Everolimus",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214138",
      "LabelerName": "Ascend Laboratories, LLC",
      "SubstanceName": "EVEROLIMUS",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:  Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1)  Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use:  Safety and efficacy have not been established in the following:  Kidney transplant patients at high immunologic risk (1.3)  Recipients of transplanted organs other than kidney or liver (1.3, 5.7)  Pediatric patients (less than 18 years) (1.3).",
      "Description": "Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)­ 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36­ dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients."
    },
    {
      "NDCCode": "68828-716-01",
      "PackageDescription": "1 KIT in 1 KIT (68828-716-01)  *  7.5 mL in 1 TUBE (68828-723-01)  *  7.5 mL in 1 TUBE (68828-717-01)  *  7.5 mL in 1 TUBE (68828-726-01)  *  7.5 mL in 1 TUBE (68828-725-01)  *  7.5 mL in 1 TUBE (68828-724-01)  *  7.5 mL in 1 TUBE (68828-718-01)  *  7.5 mL in 1 TUBE (68828-722-01)  *  7.5 mL in 1 TUBE (68828-721-01)  *  7.5 mL in 1 TUBE (68828-720-01)  *  7.5 mL in 1 TUBE (68828-719-01) ",
      "NDC11Code": "68828-0716-01",
      "ProductNDC": "68828-716",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Always Foundation Makeup Broad Spectrum Spf 15 Deluxe Sample Kit",
      "NonProprietaryName": "Homosalate, Octisalate, Zinc Oxide",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220105",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Jafra Cosmetics International",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220105",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"10237-719-15","ProprietaryName":"Orajel Dry Mouth Moistruizing","NonProprietaryName":"Glycerin"},{"NDCCode":"43353-719-15","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"},{"NDCCode":"50809-001-08","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"55289-719-15","ProprietaryName":"Tramadol Hydrochloride","NonProprietaryName":"Tramadol Hydrochloride"},{"NDCCode":"58160-894-15","ProprietaryName":"Arexvy","NonProprietaryName":"Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted"},{"NDCCode":"60760-719-15","ProprietaryName":"Tizanidine","NonProprietaryName":"Tizanidine"},{"NDCCode":"63187-719-15","ProprietaryName":"Oxycodone And Acetaminophen","NonProprietaryName":"Oxycodone And Acetaminophen"},{"NDCCode":"71919-719-07","ProprietaryName":"Wyethia Helenioides","NonProprietaryName":"Wyethia Helenioides"},{"NDCCode":"84756-719-02","ProprietaryName":"Beard Oil","NonProprietaryName":"Beard Oil"},{"NDCCode":"10237-463-15","ProprietaryName":"Zicam Allergy Relief","NonProprietaryName":"Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur"},{"NDCCode":"10237-464-15","ProprietaryName":"Zicam Extreme Congestion Relief","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"10237-471-15","ProprietaryName":"Zicam Intense Sinus Relief","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"10237-474-15","ProprietaryName":"Zicam Cold Remedy","NonProprietaryName":"Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed"},{"NDCCode":"10237-591-15","ProprietaryName":"Arm And Hammer Baking Soda","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"10237-696-15","ProprietaryName":"Simple Saline Plus Childrens","NonProprietaryName":"Luffa Operculata, Sabadilla"},{"NDCCode":"10237-755-12","ProprietaryName":"Orajel Instant Pain Relief","NonProprietaryName":"Benzocaine 20%"},{"NDCCode":"10237-774-15","ProprietaryName":"Rephresh Cooling","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"11822-0678-1","ProprietaryName":"Hemorrhoid Relief","NonProprietaryName":"Mineral Oil, Petrolatum, Phenylephrine Hcl"},{"NDCCode":"42507-719-08","ProprietaryName":"Le Techniq","NonProprietaryName":"Triclosan"},{"NDCCode":"49281-719-10","ProprietaryName":"Flublok Quadrivalent","NonProprietaryName":"Influenza A Virus A/brisbane/02/2018 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/kansas/14/2017 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen"},{"NDCCode":"49527-719-01","ProprietaryName":"Repairwear Lift","NonProprietaryName":"Octinoxate, Octisalate, Titanium Dioxide"},{"NDCCode":"50580-719-12","ProprietaryName":"Zyrtec-d","NonProprietaryName":"Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride"},{"NDCCode":"50580-719-24","ProprietaryName":"Zyrtec-d","NonProprietaryName":"Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride"},{"NDCCode":"52584-719-01","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"55111-719-05","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"55111-719-30","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"59158-719-01","ProprietaryName":"All You Need","NonProprietaryName":"Homosalate, Octinoxate, Avobenzone"},{"NDCCode":"67877-719-31","ProprietaryName":"Everolimus","NonProprietaryName":"Everolimus"},{"NDCCode":"67877-719-60","ProprietaryName":"Everolimus","NonProprietaryName":"Everolimus"},{"NDCCode":"68828-716-01","ProprietaryName":"Always Foundation Makeup Broad Spectrum Spf 15 Deluxe Sample Kit","NonProprietaryName":"Homosalate, Octisalate, Zinc Oxide"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>10237-719-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-719-15)  &gt; 42 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0719-15</NDC11Code>
    <ProductNDC>10237-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orajel Dry Mouth Moistruizing</ProprietaryName>
    <NonProprietaryName>Glycerin</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100721</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>GLYCERIN</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43353-719-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (43353-719-15)</PackageDescription>
    <NDC11Code>43353-0719-15</NDC11Code>
    <ProductNDC>43353-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19730112</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA083177</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-10-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
    <Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&amp;C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>50809-001-08</NDCCode>
    <PackageDescription>719.15 L in 1 DEWAR (50809-001-08) </PackageDescription>
    <NDC11Code>50809-0001-08</NDC11Code>
    <ProductNDC>50809-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20100517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Abilene Oxygen Inc.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55289-719-15</NDCCode>
    <PackageDescription>15 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-719-15) </PackageDescription>
    <NDC11Code>55289-0719-15</NDC11Code>
    <ProductNDC>55289-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58160-894-15</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (58160-894-15)  *  .5 mL in 1 VIAL (58160-719-03)  *  .5 mL in 1 SYRINGE (58160-749-07) </PackageDescription>
    <NDC11Code>58160-0894-15</NDC11Code>
    <ProductNDC>58160-894</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Arexvy</ProprietaryName>
    <NonProprietaryName>Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20260430</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125775</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
    <Description>AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-719-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (60760-719-15) </PackageDescription>
    <NDC11Code>60760-0719-15</NDC11Code>
    <ProductNDC>60760-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tizanidine</ProprietaryName>
    <NonProprietaryName>Tizanidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076416</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1)].</IndicationAndUsage>
    <Description>Tizanidine Tablets, USP  (tizanidine hydrochloride) is a central alpha 2-adrenergic agonist. Tizanidine HCl is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine's molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is: Tizanidine Tablets, USP are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine Tablets, USP contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base and  4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose, lactose monohydrate and anhydrous lactose.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-719-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (63187-719-15) </PackageDescription>
    <NDC11Code>63187-0719-15</NDC11Code>
    <ProductNDC>63187-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160309</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202677</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2019-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
    <Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 5 mg*Acetaminophen, USP 325 mg*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. All strengths of Oxycodone and Acetaminophen Tablets also contain the following inactive ingredients: Pregelatinized cornstarch, povidone, lactose monohydrate, crospovidone, and stearic acid. In addition, the 5 mg/325 mg strength contains FD&amp;C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&amp;C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&amp;C Yellow No. 10 Aluminum Lake. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-719-07</NDCCode>
    <PackageDescription>15 mL in 1 VIAL, GLASS (71919-719-07) </PackageDescription>
    <NDC11Code>71919-0719-07</NDC11Code>
    <ProductNDC>71919-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wyethia Helenioides</ProprietaryName>
    <NonProprietaryName>Wyethia Helenioides</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>WYETHIA HELENIOIDES ROOT</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84756-719-02</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (84756-719-02) </PackageDescription>
    <NDC11Code>84756-0719-02</NDC11Code>
    <ProductNDC>84756-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Beard Oil</ProprietaryName>
    <NonProprietaryName>Beard Oil</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241212</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-463-15</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (10237-463-15)  / 15 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>10237-0463-15</NDC11Code>
    <ProductNDC>10237-463</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zicam Allergy Relief</ProprietaryName>
    <NonProprietaryName>Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20211001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR</SubstanceName>
    <StrengthNumber>30; 200; 30; 200</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Effective Relief of Allergy Symptoms: runny noseitchy nosewatery eyessneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-464-15</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (10237-464-15)  / 15 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>10237-0464-15</NDC11Code>
    <ProductNDC>10237-464</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zicam Extreme Congestion Relief</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20211001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves nasal congestion due to: the common coldhay feverupper respiratory allergies. temporarily relieves sinus congestion and pressure. helps clear nasal passages. shrinks swollen membranes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-471-15</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (10237-471-15)  / 15 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>10237-0471-15</NDC11Code>
    <ProductNDC>10237-471</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zicam Intense Sinus Relief</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20220228</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves nasal congestion due to: the common coldhay feverupper respiratory allergies. temporarily relieves sinus congestion and pressure. helps clear nasal passages. shrinks swollen membranes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-474-15</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (10237-474-15)  / 15 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>10237-0474-15</NDC11Code>
    <ProductNDC>10237-474</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zicam Cold Remedy</ProprietaryName>
    <NonProprietaryName>Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20220410</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED</SubstanceName>
    <StrengthNumber>4; 4; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Reduces duration of the common cold and helps relieve nasal congestion. ---------------------------------------------------------------------------------------------------. Zicam ® Cold Remedy was not formulated to be effective for flu or allergies.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-591-15</NDCCode>
    <PackageDescription>680000 g in 1 BAG (10237-591-15) </PackageDescription>
    <NDC11Code>10237-0591-15</NDC11Code>
    <ProductNDC>10237-591</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arm And Hammer Baking Soda</ProprietaryName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-696-15</NDCCode>
    <PackageDescription>45 mL in 1 CAN (10237-696-15)</PackageDescription>
    <NDC11Code>10237-0696-15</NDC11Code>
    <ProductNDC>10237-696</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Simple Saline Plus Childrens</ProprietaryName>
    <ProprietaryNameSuffix>Cold Formula Plus Moisturizers</ProprietaryNameSuffix>
    <NonProprietaryName>Luffa Operculata, Sabadilla</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20110512</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED</SubstanceName>
    <StrengthNumber>6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>according to homeopathic principles, the active ingredients in this medication temporarily relieve symptoms of: 1 nasal congestion, 2 runny nose due to colds and flu, 3 post-nasal drip, 4 dry, irritated nasal passages, 5 sinus congestion and pressure.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-755-12</NDCCode>
    <PackageDescription>12 APPLICATOR in 1 CARTON (10237-755-12)  &gt; .15 g in 1 APPLICATOR</PackageDescription>
    <NDC11Code>10237-0755-12</NDC11Code>
    <ProductNDC>10237-755</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Orajel Instant Pain Relief</ProprietaryName>
    <ProprietaryNameSuffix>Maximum</ProprietaryNameSuffix>
    <NonProprietaryName>Benzocaine 20%</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100811</StartMarketingDate>
    <EndMarketingDate>20220531</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100811</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10237-774-15</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (10237-774-15)  / 15 g in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0774-15</NDC11Code>
    <ProductNDC>10237-774</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rephresh Cooling</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <EndMarketingDate>20250131</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of external feminine itching. Other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11822-0678-1</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11822-0678-1)  &gt; 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>11822-0678-01</NDC11Code>
    <ProductNDC>11822-0678</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hemorrhoid Relief</ProprietaryName>
    <NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20121012</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Rite Aid Corporation</LabelerName>
    <SubstanceName>MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>140; 719; 2.5</StrengthNumber>
    <StrengthUnit>mg/100g; mg/100g; mg/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-15</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42507-719-08</NDCCode>
    <PackageDescription>222 mL in 1 BOTTLE, PLASTIC (42507-719-08)</PackageDescription>
    <NDC11Code>42507-0719-08</NDC11Code>
    <ProductNDC>42507-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Le Techniq</ProprietaryName>
    <ProprietaryNameSuffix>Morning Mist Antibacterial Hand</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140225</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>HYVEE INC</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>1.15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>HELPS REDUCE BACTERIA ON THE SKIN.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49281-719-10</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (49281-719-10)  &gt; .5 mL in 1 SYRINGE (49281-719-88) </PackageDescription>
    <NDC11Code>49281-0719-10</NDC11Code>
    <ProductNDC>49281-719</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Flublok Quadrivalent</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/brisbane/02/2018 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/kansas/14/2017 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20190701</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125285</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
    <StrengthNumber>45; 45; 45; 45</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49527-719-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (49527-719-01)  &gt; 50 mL in 1 JAR (49527-719-02)</PackageDescription>
    <NDC11Code>49527-0719-01</NDC11Code>
    <ProductNDC>49527-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Repairwear Lift</ProprietaryName>
    <ProprietaryNameSuffix>Spf 15 Firming Day Dry Combo Skin</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20070401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CLINIQUE LABORATORIES INC</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>7.5; 3.5; 1</StrengthNumber>
    <StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>50580-719-12</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (50580-719-12)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50580-0719-12</NDC11Code>
    <ProductNDC>50580-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zyrtec-d</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230228</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021150</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 120</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50580-719-24</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (50580-719-24)  / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50580-0719-24</NDC11Code>
    <ProductNDC>50580-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zyrtec-d</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230228</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021150</ApplicationNumber>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 120</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52584-719-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (52584-719-01)  &gt; 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>52584-0719-01</NDC11Code>
    <ProductNDC>52584-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20210714</StartMarketingDate>
    <EndMarketingDate>20231031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204216</ApplicationNumber>
    <LabelerName>General Injectables and Vaccines, Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210714</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55111-719-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-719-05) </PackageDescription>
    <NDC11Code>55111-0719-05</NDC11Code>
    <ProductNDC>55111-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202383</ApplicationNumber>
    <LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&amp;C Red # 27 (250 mg), FD&amp;C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-719-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-719-30) </PackageDescription>
    <NDC11Code>55111-0719-30</NDC11Code>
    <ProductNDC>55111-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202383</ApplicationNumber>
    <LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&amp;C Red # 27 (250 mg), FD&amp;C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>59158-719-01</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (59158-719-01)  &gt; 50 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>59158-0719-01</NDC11Code>
    <ProductNDC>59158-719</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All You Need</ProprietaryName>
    <ProprietaryNameSuffix>Continuous Action 24 Hour Moisture Spf 15 For Normal Skin</ProprietaryNameSuffix>
    <NonProprietaryName>Homosalate, Octinoxate, Avobenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>PRESCRIPTIVES INC.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTINOXATE; AVOBENZONE</SubstanceName>
    <StrengthNumber>5; 5; 3</StrengthNumber>
    <StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67877-719-31</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (67877-719-31)  / 10 TABLET in 1 BLISTER PACK (67877-719-33) </PackageDescription>
    <NDC11Code>67877-0719-31</NDC11Code>
    <ProductNDC>67877-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214138</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:  Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1)  Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use:  Safety and efficacy have not been established in the following:  Kidney transplant patients at high immunologic risk (1.3)  Recipients of transplanted organs other than kidney or liver (1.3, 5.7)  Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
    <Description>Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)­ 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36­ dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>67877-719-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (67877-719-60) </PackageDescription>
    <NDC11Code>67877-0719-60</NDC11Code>
    <ProductNDC>67877-719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214138</ApplicationNumber>
    <LabelerName>Ascend Laboratories, LLC</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:  Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1)  Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use:  Safety and efficacy have not been established in the following:  Kidney transplant patients at high immunologic risk (1.3)  Recipients of transplanted organs other than kidney or liver (1.3, 5.7)  Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
    <Description>Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)­ 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36­ dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>68828-716-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (68828-716-01)  *  7.5 mL in 1 TUBE (68828-723-01)  *  7.5 mL in 1 TUBE (68828-717-01)  *  7.5 mL in 1 TUBE (68828-726-01)  *  7.5 mL in 1 TUBE (68828-725-01)  *  7.5 mL in 1 TUBE (68828-724-01)  *  7.5 mL in 1 TUBE (68828-718-01)  *  7.5 mL in 1 TUBE (68828-722-01)  *  7.5 mL in 1 TUBE (68828-721-01)  *  7.5 mL in 1 TUBE (68828-720-01)  *  7.5 mL in 1 TUBE (68828-719-01) </PackageDescription>
    <NDC11Code>68828-0716-01</NDC11Code>
    <ProductNDC>68828-716</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Always Foundation Makeup Broad Spectrum Spf 15 Deluxe Sample Kit</ProprietaryName>
    <NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220105</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Jafra Cosmetics International</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220105</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>10237-719-15</NDCCode><ProprietaryName>Orajel Dry Mouth Moistruizing</ProprietaryName><NonProprietaryName>Glycerin</NonProprietaryName></NDC><NDC><NDCCode>43353-719-15</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>50809-001-08</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>55289-719-15</NDCCode><ProprietaryName>Tramadol Hydrochloride</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>58160-894-15</NDCCode><ProprietaryName>Arexvy</ProprietaryName><NonProprietaryName>Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted</NonProprietaryName></NDC><NDC><NDCCode>60760-719-15</NDCCode><ProprietaryName>Tizanidine</ProprietaryName><NonProprietaryName>Tizanidine</NonProprietaryName></NDC><NDC><NDCCode>63187-719-15</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>71919-719-07</NDCCode><ProprietaryName>Wyethia Helenioides</ProprietaryName><NonProprietaryName>Wyethia Helenioides</NonProprietaryName></NDC><NDC><NDCCode>84756-719-02</NDCCode><ProprietaryName>Beard Oil</ProprietaryName><NonProprietaryName>Beard Oil</NonProprietaryName></NDC><NDC><NDCCode>10237-463-15</NDCCode><ProprietaryName>Zicam Allergy Relief</ProprietaryName><NonProprietaryName>Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, And Sulfur</NonProprietaryName></NDC><NDC><NDCCode>10237-464-15</NDCCode><ProprietaryName>Zicam Extreme Congestion Relief</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10237-471-15</NDCCode><ProprietaryName>Zicam Intense Sinus Relief</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10237-474-15</NDCCode><ProprietaryName>Zicam Cold Remedy</ProprietaryName><NonProprietaryName>Galphimia Glauca Flowering Top, Luffa Operculata Fruit, And Schoenocaulon Officinale Seed</NonProprietaryName></NDC><NDC><NDCCode>10237-591-15</NDCCode><ProprietaryName>Arm And Hammer Baking Soda</ProprietaryName><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>10237-696-15</NDCCode><ProprietaryName>Simple Saline Plus Childrens</ProprietaryName><NonProprietaryName>Luffa Operculata, Sabadilla</NonProprietaryName></NDC><NDC><NDCCode>10237-755-12</NDCCode><ProprietaryName>Orajel Instant Pain Relief</ProprietaryName><NonProprietaryName>Benzocaine 20%</NonProprietaryName></NDC><NDC><NDCCode>10237-774-15</NDCCode><ProprietaryName>Rephresh Cooling</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>11822-0678-1</NDCCode><ProprietaryName>Hemorrhoid Relief</ProprietaryName><NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>42507-719-08</NDCCode><ProprietaryName>Le Techniq</ProprietaryName><NonProprietaryName>Triclosan</NonProprietaryName></NDC><NDC><NDCCode>49281-719-10</NDCCode><ProprietaryName>Flublok Quadrivalent</ProprietaryName><NonProprietaryName>Influenza A Virus A/brisbane/02/2018 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/kansas/14/2017 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen</NonProprietaryName></NDC><NDC><NDCCode>49527-719-01</NDCCode><ProprietaryName>Repairwear Lift</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>50580-719-12</NDCCode><ProprietaryName>Zyrtec-d</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50580-719-24</NDCCode><ProprietaryName>Zyrtec-d</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>52584-719-01</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>55111-719-05</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>55111-719-30</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>59158-719-01</NDCCode><ProprietaryName>All You Need</ProprietaryName><NonProprietaryName>Homosalate, Octinoxate, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>67877-719-31</NDCCode><ProprietaryName>Everolimus</ProprietaryName><NonProprietaryName>Everolimus</NonProprietaryName></NDC><NDC><NDCCode>67877-719-60</NDCCode><ProprietaryName>Everolimus</ProprietaryName><NonProprietaryName>Everolimus</NonProprietaryName></NDC><NDC><NDCCode>68828-716-01</NDCCode><ProprietaryName>Always Foundation Makeup Broad Spectrum Spf 15 Deluxe Sample Kit</ProprietaryName><NonProprietaryName>Homosalate, Octisalate, Zinc Oxide</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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",
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      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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}
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