RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "76420-207-15",
      "PackageDescription": "5 PATCH in 1 BOX (76420-207-15)  > 4 g in 1 PATCH",
      "NDC11Code": "76420-0207-15",
      "ProductNDC": "76420-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sportcaine Patch",
      "NonProprietaryName": "Lidocaine 4%, Menthol 1%",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220928",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "LIDOCAINE; MENTHOL, UNSPECIFIED FORM",
      "StrengthNumber": "4; 1",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220928",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "21695-207-15",
      "PackageDescription": "1 TUBE in 1 CARTON (21695-207-15)  > 15 g in 1 TUBE",
      "NDC11Code": "21695-0207-15",
      "ProductNDC": "21695-207",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluocinonide",
      "NonProprietaryName": "Fluocinonide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19840626",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA019117",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "FLUOCINONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base), FLUOCINONIDE GEL USP, 0.05% and FLUOCINONIDE OINTMENT USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base), FLUOCINONIDE GEL USP, 0.05% and FLUOCINONIDE OINTMENT USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis)oxy)]-,(6α,11β,16α)-. It has the following chemical structure. FLUOCINONIDE CREAM USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol, 1,2,6-hexanetriol, glycerin and citric acid. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monosterarate, polysorbate 60, white petrolatum, citric acid (anhydrous) and purified water. FLUOCINONIDE GEL USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. FLUOCINONIDE OINTMENT USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE GEL USP, 0.05%, and FLUOCINONIDE OINTMENT USP, 0.05% formulations, the active ingredient is totally in solution."
    },
    {
      "NDCCode": "42002-207-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (42002-207-05)  > 15 mL in 1 BOTTLE",
      "NDC11Code": "42002-0207-05",
      "ProductNDC": "42002-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Visine Tears",
      "ProprietaryNameSuffix": "Long Lasting Dry Eye Relief",
      "NonProprietaryName": "Glycerin, Hypromelloses, And Polyethylene Glycol 400",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20110909",
      "EndMarketingDate": "20181001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400",
      "StrengthNumber": "2; 3.6; 10",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-02",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "51508-207-15",
      "PackageDescription": "15 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (51508-207-15) ",
      "NDC11Code": "51508-0207-15",
      "ProductNDC": "51508-207",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dutasteride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20241119",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Hubei Gedian humanwell Pharmaceutical Co., Ltd",
      "SubstanceName": "DUTASTERIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-15",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "26-SEP-25"
    },
    {
      "NDCCode": "55289-207-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (55289-207-15)",
      "NDC11Code": "55289-0207-15",
      "ProductNDC": "55289-207",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penicillin V Potassium",
      "NonProprietaryName": "Penicillin V Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19951130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064071",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "PENICILLIN V POTASSIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-08-03",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "61748-207-15",
      "PackageDescription": "1 TUBE in 1 CARTON (61748-207-15)  > 15 g in 1 TUBE",
      "NDC11Code": "61748-0207-15",
      "ProductNDC": "61748-207",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desoximetasone",
      "NonProprietaryName": "Desoximetasone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203787",
      "LabelerName": "VersaPharm Inc. - an Akorn Company",
      "SubstanceName": "DESOXIMETASONE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20170119",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71073-207-35",
      "PackageDescription": "15 PATCH in 1 BOX (71073-207-35) ",
      "NDC11Code": "71073-0207-35",
      "ProductNDC": "71073-207",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gen7t Plus",
      "NonProprietaryName": "Lidocaine, Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200729",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Beijing HKKY Medical Tech. Co., Ltd.",
      "SubstanceName": "LIDOCAINE; MENTHOL",
      "StrengthNumber": "490; 980",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200729",
      "SamplePackage": "N",
      "Description": "Gen7T PlusPatch® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C 14H 22N 2O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure:. ** Lidocaine**. Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C 10H 20O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31 OC to 36 OC and has the following structure:. ** Menthol**. Gen7T PlusPatch®uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin."
    },
    {
      "NDCCode": "71205-207-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (71205-207-15) ",
      "NDC11Code": "71205-0207-15",
      "ProductNDC": "71205-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078336",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-04-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191001",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 1.runny nose, 2 2.sneezing, 3 3.itchy, watery eyes, 4 4.itching of the nose or throat."
    },
    {
      "NDCCode": "71919-207-07",
      "PackageDescription": "15 mL in 1 VIAL, GLASS (71919-207-07) ",
      "NDC11Code": "71919-0207-07",
      "ProductNDC": "71919-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clematis Erecta",
      "NonProprietaryName": "Clematis Recta Flowering Top",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100305",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "CLEMATIS RECTA FLOWERING TOP",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20100305",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "75834-207-15",
      "PackageDescription": "150 CAPSULE in 1 BOTTLE (75834-207-15) ",
      "NDC11Code": "75834-0207-15",
      "ProductNDC": "75834-207",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tizanidine Hydrochloride",
      "NonProprietaryName": "Tizanidine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190926",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210021",
      "LabelerName": "Nivagen Pharmaceuticals, Inc.",
      "SubstanceName": "TIZANIDINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].",
      "Description": "Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine HCl is a white to slight⍰ yellow crystalline powder. Tizanidine is soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2, 1 ,3-benzothiadiazole hydrochloride. Tizanidine's molecular formula is C9H8CIN5S-HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine hydrochloride capsules are supplied as 2, 4, and 6 mg capsules for oral administration. Tizanidine hydrochloride capsules contain the active ingredient, tizanidine hydrochloride (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base), and the inactive ingredients, lactose monohydrate, hypromellose, microcrystalline cellulose and colloidal silicon dioxide. Each capsule shell contains FD & C Blue t, FD & C Red 3, titanium dioxide and gelatin. The capsules are printed with SW-0012 while ink which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, and titanium dioxide."
    },
    {
      "NDCCode": "76138-207-05",
      "PackageDescription": "15 mL in 1 BOTTLE, PLASTIC (76138-207-05)",
      "NDC11Code": "76138-0207-05",
      "ProductNDC": "76138-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "5281 Sunscreen",
      "NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Innovation Specialties",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
      "StrengthNumber": "7.5; 2; 4; 2.5",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "76731-207-01",
      "PackageDescription": "15 g in 1 BOTTLE (76731-207-01) ",
      "NDC11Code": "76731-0207-01",
      "ProductNDC": "76731-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cell 97.7 Re-activated Perfect Lifting Eye Cream",
      "NonProprietaryName": "Niacinamide, Adenosine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200904",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "BBHC CO., LTD",
      "SubstanceName": "ADENOSINE; NIACINAMIDE",
      "StrengthNumber": ".04; 2",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200904",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83455-207-01",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (83455-207-01)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "83455-0207-01",
      "ProductNDC": "83455-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equaline Multi-symptom Eye Drops",
      "NonProprietaryName": "Polyethylene Glycol 400, Tetrahydrozoline Hcl, Zinc Sulfate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20230620",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M018",
      "LabelerName": "United Natural Foods, Inc.",
      "SubstanceName": "ZINC SULFATE; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".25; 1; .05",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230620",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves dryness of the eye. for temporary relief of discomfort and redness of the eye due to minor eye irritations. for temporary relief of burning and irritation due to exposure to wind or sun. for protection against further irritation ."
    },
    {
      "NDCCode": "84369-207-01",
      "PackageDescription": "15 g in 1 BOX (84369-207-01) ",
      "NDC11Code": "84369-0207-01",
      "ProductNDC": "84369-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sleep Patch",
      "NonProprietaryName": "Sleep Patch",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241011",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M010",
      "LabelerName": "Shenzhen Rongxing Trading Co., Ltd.",
      "SubstanceName": "HAMAMELIS VIRGINIANA TOP WATER",
      "StrengthNumber": "72",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241011",
      "SamplePackage": "N",
      "IndicationAndUsage": "For external use only. Avoid direct contact with eyes. Discontinue use if irritation occur. Keep out of reach of childeren. Store in a cool and dry place."
    },
    {
      "NDCCode": "84515-207-01",
      "PackageDescription": "15 mL in 1 BOX (84515-207-01) ",
      "NDC11Code": "84515-0207-01",
      "ProductNDC": "84515-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hair Growth Oil",
      "NonProprietaryName": "Hair Growth Oil",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241008",
      "EndMarketingDate": "20311031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Yiwu�Xinqian�E�Commerce�Co�Ltd",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20241008",
      "EndMarketingDatePackage": "20311031",
      "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": "84525-207-01",
      "PackageDescription": "15 g in 1 BOX (84525-207-01) ",
      "NDC11Code": "84525-0207-01",
      "ProductNDC": "84525-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Keratin Mask For Dry Damaged Hair",
      "NonProprietaryName": "Trstay Keratin Mask For Dry Damaged Hair",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241030",
      "EndMarketingDate": "20311031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20241030",
      "EndMarketingDatePackage": "20311031",
      "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": "84756-207-01",
      "PackageDescription": "15 mL in 1 BOTTLE (84756-207-01) ",
      "NDC11Code": "84756-0207-01",
      "ProductNDC": "84756-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Beard Growth",
      "NonProprietaryName": "Beard Growth",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241103",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241103",
      "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": "84827-207-01",
      "PackageDescription": "15 g in 1 BOX (84827-207-01) ",
      "NDC11Code": "84827-0207-01",
      "ProductNDC": "84827-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Turmeric Moisture And",
      "NonProprietaryName": "Trstay Turmeric Moisture And",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241031",
      "EndMarketingDate": "20311231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20241031",
      "EndMarketingDatePackage": "20311231",
      "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": "84864-207-02",
      "PackageDescription": "15 g in 1 BOX (84864-207-02) ",
      "NDC11Code": "84864-0207-02",
      "ProductNDC": "84864-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Eye Cream",
      "NonProprietaryName": "Eye Cream",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20241118",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Jingmo trade Co., LTD",
      "SubstanceName": "COPPER TRIPEPTIDE-1",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply to skin until absorbed."
    },
    {
      "NDCCode": "85766-207-15",
      "PackageDescription": "1 TUBE in 1 CARTON (85766-207-15)  / 15 g in 1 TUBE",
      "NDC11Code": "85766-0207-15",
      "ProductNDC": "85766-207",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mupirocin",
      "NonProprietaryName": "Mupirocin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050923",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065170",
      "LabelerName": "Sportpharm LLC",
      "SubstanceName": "MUPIROCIN",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260512",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus)and Streptococcus pyogenes (S. pyogenes).",
      "Description": "Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl] tetrahydro-3,4-dihydroxy-ß-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26H 44O 9, and the molecular weight is 500.6. The structural formula of mupirocin is:. Each gram of mupirocin ointment, 2% contains 20 mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment) consisting of polyethylene glycol 400 and polyethylene glycol 3350."
    },
    {
      "NDCCode": "76420-004-15",
      "PackageDescription": "150 TABLET in 1 BOTTLE, PLASTIC (76420-004-15) ",
      "NDC11Code": "76420-0004-15",
      "ProductNDC": "76420-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Anastrozole",
      "NonProprietaryName": "Anastrozole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100622",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090568",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "ANASTROZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191224",
      "SamplePackage": "N",
      "IndicationAndUsage": "Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole ( 1.3) .",
      "Description": "Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "76420-010-15",
      "PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (76420-010-15) ",
      "NDC11Code": "76420-0010-15",
      "ProductNDC": "76420-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170928",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221021",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK aof 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are supplied as 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76420-032-15",
      "PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (76420-032-15) ",
      "NDC11Code": "76420-0032-15",
      "ProductNDC": "76420-032",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980617",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074754",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220916",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.",
      "Description": "Ketorolac Tromethamine Tablets USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). The structural formula is:. C 15H 13NO 3.C 4H 11NO 3M.W. 376.40. Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Ketorolac Tromethamine Tablets USP are white, round, convex, unscored, film-coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, USP, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
    },
    {
      "NDCCode": "76420-043-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (76420-043-15) ",
      "NDC11Code": "76420-0043-15",
      "ProductNDC": "76420-043",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Meloxicam",
      "NonProprietaryName": "Meloxicam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070307",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077927",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "MELOXICAM",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-10-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221004",
      "SamplePackage": "N",
      "IndicationAndUsage": "Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (   1.3)   .",
      "Description": "Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Chemical Structure. Chemical Structure. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
    },
    {
      "NDCCode": "76420-048-29",
      "PackageDescription": ".15 g in 1 JAR (76420-048-29) ",
      "NDC11Code": "76420-0048-29",
      "ProductNDC": "76420-048",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170210",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-21",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "10-FEB-17"
    },
    {
      "NDCCode": "76420-049-35",
      "PackageDescription": ".15 g in 1 JAR (76420-049-35) ",
      "NDC11Code": "76420-0049-35",
      "ProductNDC": "76420-049",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Estriol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170210",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "ESTRIOL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-21",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "10-FEB-17"
    },
    {
      "NDCCode": "76420-050-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (76420-050-15) ",
      "NDC11Code": "76420-0050-15",
      "ProductNDC": "76420-050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070609",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077309",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2020-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200925",
      "SamplePackage": "N",
      "Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablets are a formulation for oral administration. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:."
    },
    {
      "NDCCode": "76420-069-15",
      "PackageDescription": "15 TABLET in 1 BOTTLE (76420-069-15) ",
      "NDC11Code": "76420-0069-15",
      "ProductNDC": "76420-069",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040362",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200828",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus Systemic derznatomyositis (polymyositis) Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis Regional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy-. The structural formula is represented below. Molecular weight: 358.44. Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%."
    },
    {
      "NDCCode": "76420-076-15",
      "PackageDescription": "15 mL in 1 BOTTLE, PLASTIC (76420-076-15) ",
      "NDC11Code": "76420-0076-15",
      "ProductNDC": "76420-076",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfacetamide Sodium",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20030325",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089560",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2022-10-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200116",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGE: Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma:. Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.",
      "Description": "DESCRIPTION: Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:. C 8H 9N 2Na0 3S  H 2O. MW = 254.24. Chemical Name. N-Sulfanilylacetamide monosodium salt monohydrate. Contains. Active: sulfacetamide sodium 10% (100 mg/mL). Preservative: methylparaben and propylparaben. Inactives: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate."
    },
    {
      "NDCCode": "76420-090-15",
      "PackageDescription": "15 mL in 1 BOTTLE, DROPPER (76420-090-15) ",
      "NDC11Code": "76420-0090-15",
      "ProductNDC": "76420-090",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfacetamide Sodium",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19941228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040066",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2020-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20201024",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sulfacetamide Sodium Ophthalmic Solution, USP 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.",
      "Description": "Sulfacetamide Sodium Ophthalmic Solution, USP 10% is a sterile, topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula. Chemical name: N-Sulfanilylacetamide monosodium salt monohydrate. Each mL contains:. ACTIVE: Sulfacetamide Sodium, 100 mg/mL (10%);. INACTIVES: Methylcellulose, Purified Water, Sodium Thiosulfate. Sodium Phosphate Monobasic may be added to adjust pH (6.8-8.0). PRESERVATIVES ADDED: Methylparaben 0.05% and Propylparaben 0.01%. The osmolality range is 700-1300 mOsm/kg."
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>76420-207-15</NDCCode>
    <PackageDescription>5 PATCH in 1 BOX (76420-207-15)  &gt; 4 g in 1 PATCH</PackageDescription>
    <NDC11Code>76420-0207-15</NDC11Code>
    <ProductNDC>76420-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sportcaine Patch</ProprietaryName>
    <NonProprietaryName>Lidocaine 4%, Menthol 1%</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220928</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE; MENTHOL, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>4; 1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21695-207-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21695-207-15)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>21695-0207-15</NDC11Code>
    <ProductNDC>21695-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide</ProprietaryName>
    <NonProprietaryName>Fluocinonide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19840626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA019117</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base), FLUOCINONIDE GEL USP, 0.05% and FLUOCINONIDE OINTMENT USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base), FLUOCINONIDE GEL USP, 0.05% and FLUOCINONIDE OINTMENT USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis)oxy)]-,(6α,11β,16α)-. It has the following chemical structure. FLUOCINONIDE CREAM USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol, 1,2,6-hexanetriol, glycerin and citric acid. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties. FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monosterarate, polysorbate 60, white petrolatum, citric acid (anhydrous) and purified water. FLUOCINONIDE GEL USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. FLUOCINONIDE OINTMENT USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment. In the FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE GEL USP, 0.05%, and FLUOCINONIDE OINTMENT USP, 0.05% formulations, the active ingredient is totally in solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42002-207-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (42002-207-05)  &gt; 15 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>42002-0207-05</NDC11Code>
    <ProductNDC>42002-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Visine Tears</ProprietaryName>
    <ProprietaryNameSuffix>Long Lasting Dry Eye Relief</ProprietaryNameSuffix>
    <NonProprietaryName>Glycerin, Hypromelloses, And Polyethylene Glycol 400</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20110909</StartMarketingDate>
    <EndMarketingDate>20181001</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400</SubstanceName>
    <StrengthNumber>2; 3.6; 10</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>51508-207-15</NDCCode>
    <PackageDescription>15 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (51508-207-15) </PackageDescription>
    <NDC11Code>51508-0207-15</NDC11Code>
    <ProductNDC>51508-207</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dutasteride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20241119</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Hubei Gedian humanwell Pharmaceutical Co., Ltd</LabelerName>
    <SubstanceName>DUTASTERIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>26-SEP-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>55289-207-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (55289-207-15)</PackageDescription>
    <NDC11Code>55289-0207-15</NDC11Code>
    <ProductNDC>55289-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Penicillin V Potassium</ProprietaryName>
    <NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19951130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064071</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-03</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61748-207-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (61748-207-15)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>61748-0207-15</NDC11Code>
    <ProductNDC>61748-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desoximetasone</ProprietaryName>
    <NonProprietaryName>Desoximetasone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203787</ApplicationNumber>
    <LabelerName>VersaPharm Inc. - an Akorn Company</LabelerName>
    <SubstanceName>DESOXIMETASONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71073-207-35</NDCCode>
    <PackageDescription>15 PATCH in 1 BOX (71073-207-35) </PackageDescription>
    <NDC11Code>71073-0207-35</NDC11Code>
    <ProductNDC>71073-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gen7t Plus</ProprietaryName>
    <NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200729</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Beijing HKKY Medical Tech. Co., Ltd.</LabelerName>
    <SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
    <StrengthNumber>490; 980</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Gen7T PlusPatch® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C 14H 22N 2O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure:. ** Lidocaine**. Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C 10H 20O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31 OC to 36 OC and has the following structure:. ** Menthol**. Gen7T PlusPatch®uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-207-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (71205-207-15) </PackageDescription>
    <NDC11Code>71205-0207-15</NDC11Code>
    <ProductNDC>71205-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078336</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 1.runny nose, 2 2.sneezing, 3 3.itchy, watery eyes, 4 4.itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71919-207-07</NDCCode>
    <PackageDescription>15 mL in 1 VIAL, GLASS (71919-207-07) </PackageDescription>
    <NDC11Code>71919-0207-07</NDC11Code>
    <ProductNDC>71919-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clematis Erecta</ProprietaryName>
    <NonProprietaryName>Clematis Recta Flowering Top</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100305</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>CLEMATIS RECTA FLOWERING TOP</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>75834-207-15</NDCCode>
    <PackageDescription>150 CAPSULE in 1 BOTTLE (75834-207-15) </PackageDescription>
    <NDC11Code>75834-0207-15</NDC11Code>
    <ProductNDC>75834-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210021</ApplicationNumber>
    <LabelerName>Nivagen Pharmaceuticals, Inc.</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>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine 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 hydrochloride is a central alpha2-adrenergic agonist. Tizanidine HCl is a white to slight⍰ yellow crystalline powder. Tizanidine is soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2, 1 ,3-benzothiadiazole hydrochloride. Tizanidine's molecular formula is C9H8CIN5S-HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine hydrochloride capsules are supplied as 2, 4, and 6 mg capsules for oral administration. Tizanidine hydrochloride capsules contain the active ingredient, tizanidine hydrochloride (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base), and the inactive ingredients, lactose monohydrate, hypromellose, microcrystalline cellulose and colloidal silicon dioxide. Each capsule shell contains FD &amp; C Blue t, FD &amp; C Red 3, titanium dioxide and gelatin. The capsules are printed with SW-0012 while ink which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76138-207-05</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE, PLASTIC (76138-207-05)</PackageDescription>
    <NDC11Code>76138-0207-05</NDC11Code>
    <ProductNDC>76138-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>5281 Sunscreen</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Innovation Specialties</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>7.5; 2; 4; 2.5</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76731-207-01</NDCCode>
    <PackageDescription>15 g in 1 BOTTLE (76731-207-01) </PackageDescription>
    <NDC11Code>76731-0207-01</NDC11Code>
    <ProductNDC>76731-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cell 97.7 Re-activated Perfect Lifting Eye Cream</ProprietaryName>
    <NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200904</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>BBHC CO., LTD</LabelerName>
    <SubstanceName>ADENOSINE; NIACINAMIDE</SubstanceName>
    <StrengthNumber>.04; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83455-207-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (83455-207-01)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>83455-0207-01</NDC11Code>
    <ProductNDC>83455-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equaline Multi-symptom Eye Drops</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 400, Tetrahydrozoline Hcl, Zinc Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20230620</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M018</ApplicationNumber>
    <LabelerName>United Natural Foods, Inc.</LabelerName>
    <SubstanceName>ZINC SULFATE; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25; 1; .05</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves dryness of the eye. for temporary relief of discomfort and redness of the eye due to minor eye irritations. for temporary relief of burning and irritation due to exposure to wind or sun. for protection against further irritation .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84369-207-01</NDCCode>
    <PackageDescription>15 g in 1 BOX (84369-207-01) </PackageDescription>
    <NDC11Code>84369-0207-01</NDC11Code>
    <ProductNDC>84369-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sleep Patch</ProprietaryName>
    <NonProprietaryName>Sleep Patch</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241011</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M010</ApplicationNumber>
    <LabelerName>Shenzhen Rongxing Trading Co., Ltd.</LabelerName>
    <SubstanceName>HAMAMELIS VIRGINIANA TOP WATER</SubstanceName>
    <StrengthNumber>72</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241011</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For external use only. Avoid direct contact with eyes. Discontinue use if irritation occur. Keep out of reach of childeren. Store in a cool and dry place.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84515-207-01</NDCCode>
    <PackageDescription>15 mL in 1 BOX (84515-207-01) </PackageDescription>
    <NDC11Code>84515-0207-01</NDC11Code>
    <ProductNDC>84515-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hair Growth Oil</ProprietaryName>
    <NonProprietaryName>Hair Growth Oil</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241008</StartMarketingDate>
    <EndMarketingDate>20311031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Yiwu�Xinqian�E�Commerce�Co�Ltd</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241008</StartMarketingDatePackage>
    <EndMarketingDatePackage>20311031</EndMarketingDatePackage>
    <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>84525-207-01</NDCCode>
    <PackageDescription>15 g in 1 BOX (84525-207-01) </PackageDescription>
    <NDC11Code>84525-0207-01</NDC11Code>
    <ProductNDC>84525-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Keratin Mask For Dry Damaged Hair</ProprietaryName>
    <NonProprietaryName>Trstay Keratin Mask For Dry Damaged Hair</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241030</StartMarketingDate>
    <EndMarketingDate>20311031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241030</StartMarketingDatePackage>
    <EndMarketingDatePackage>20311031</EndMarketingDatePackage>
    <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>84756-207-01</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (84756-207-01) </PackageDescription>
    <NDC11Code>84756-0207-01</NDC11Code>
    <ProductNDC>84756-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Beard Growth</ProprietaryName>
    <NonProprietaryName>Beard Growth</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Yiwu Luoxin E� Commerce Co Ltd</LabelerName>
    <SubstanceName>MINOXIDIL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241103</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>84827-207-01</NDCCode>
    <PackageDescription>15 g in 1 BOX (84827-207-01) </PackageDescription>
    <NDC11Code>84827-0207-01</NDC11Code>
    <ProductNDC>84827-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Turmeric Moisture And</ProprietaryName>
    <NonProprietaryName>Trstay Turmeric Moisture And</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241031</StartMarketingDate>
    <EndMarketingDate>20311231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241031</StartMarketingDatePackage>
    <EndMarketingDatePackage>20311231</EndMarketingDatePackage>
    <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>84864-207-02</NDCCode>
    <PackageDescription>15 g in 1 BOX (84864-207-02) </PackageDescription>
    <NDC11Code>84864-0207-02</NDC11Code>
    <ProductNDC>84864-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eye Cream</ProprietaryName>
    <NonProprietaryName>Eye Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20241118</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Jingmo trade Co., LTD</LabelerName>
    <SubstanceName>COPPER TRIPEPTIDE-1</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply to skin until absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85766-207-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (85766-207-15)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>85766-0207-15</NDC11Code>
    <ProductNDC>85766-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mupirocin</ProprietaryName>
    <NonProprietaryName>Mupirocin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050923</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065170</ApplicationNumber>
    <LabelerName>Sportpharm LLC</LabelerName>
    <SubstanceName>MUPIROCIN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus)and Streptococcus pyogenes (S. pyogenes).</IndicationAndUsage>
    <Description>Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl] tetrahydro-3,4-dihydroxy-ß-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26H 44O 9, and the molecular weight is 500.6. The structural formula of mupirocin is:. Each gram of mupirocin ointment, 2% contains 20 mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment) consisting of polyethylene glycol 400 and polyethylene glycol 3350.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-004-15</NDCCode>
    <PackageDescription>150 TABLET in 1 BOTTLE, PLASTIC (76420-004-15) </PackageDescription>
    <NDC11Code>76420-0004-15</NDC11Code>
    <ProductNDC>76420-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anastrozole</ProprietaryName>
    <NonProprietaryName>Anastrozole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090568</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ANASTROZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole ( 1.3) .</IndicationAndUsage>
    <Description>Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-010-15</NDCCode>
    <PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (76420-010-15) </PackageDescription>
    <NDC11Code>76420-0010-15</NDC11Code>
    <ProductNDC>76420-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078722</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK aof 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are supplied as 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-032-15</NDCCode>
    <PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (76420-032-15) </PackageDescription>
    <NDC11Code>76420-0032-15</NDC11Code>
    <ProductNDC>76420-032</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980617</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074754</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Tablets USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). The structural formula is:. C 15H 13NO 3.C 4H 11NO 3M.W. 376.40. Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Ketorolac Tromethamine Tablets USP are white, round, convex, unscored, film-coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, USP, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-043-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (76420-043-15) </PackageDescription>
    <NDC11Code>76420-0043-15</NDC11Code>
    <ProductNDC>76420-043</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meloxicam</ProprietaryName>
    <NonProprietaryName>Meloxicam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077927</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>MELOXICAM</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221004</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (   1.3)   .</IndicationAndUsage>
    <Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Chemical Structure. Chemical Structure. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-048-29</NDCCode>
    <PackageDescription>.15 g in 1 JAR (76420-048-29) </PackageDescription>
    <NDC11Code>76420-0048-29</NDC11Code>
    <ProductNDC>76420-048</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170210</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-21</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>10-FEB-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>76420-049-35</NDCCode>
    <PackageDescription>.15 g in 1 JAR (76420-049-35) </PackageDescription>
    <NDC11Code>76420-0049-35</NDC11Code>
    <ProductNDC>76420-049</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Estriol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170210</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ESTRIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-21</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>10-FEB-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>76420-050-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (76420-050-15) </PackageDescription>
    <NDC11Code>76420-0050-15</NDC11Code>
    <ProductNDC>76420-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070609</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077309</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200925</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablets are a formulation for oral administration. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-069-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (76420-069-15) </PackageDescription>
    <NDC11Code>76420-0069-15</NDC11Code>
    <ProductNDC>76420-069</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010829</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040362</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus Systemic derznatomyositis (polymyositis) Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis             Serum sickness            Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis Regional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently  with appropriate antituberculous chemotherapy            Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy-. The structural formula is represented below. Molecular weight: 358.44. Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD &amp; C yellow #6 aluminum lake HT 15-18%.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-076-15</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE, PLASTIC (76420-076-15) </PackageDescription>
    <NDC11Code>76420-0076-15</NDC11Code>
    <ProductNDC>76420-076</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfacetamide Sodium</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20030325</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089560</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGE: Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma:. Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.</IndicationAndUsage>
    <Description>DESCRIPTION: Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:. C 8H 9N 2Na0 3S  H 2O. MW = 254.24. Chemical Name. N-Sulfanilylacetamide monosodium salt monohydrate. Contains. Active: sulfacetamide sodium 10% (100 mg/mL). Preservative: methylparaben and propylparaben. Inactives: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-090-15</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE, DROPPER (76420-090-15) </PackageDescription>
    <NDC11Code>76420-0090-15</NDC11Code>
    <ProductNDC>76420-090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfacetamide Sodium</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19941228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040066</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sulfacetamide Sodium Ophthalmic Solution, USP 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.</IndicationAndUsage>
    <Description>Sulfacetamide Sodium Ophthalmic Solution, USP 10% is a sterile, topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula. Chemical name: N-Sulfanilylacetamide monosodium salt monohydrate. Each mL contains:. ACTIVE: Sulfacetamide Sodium, 100 mg/mL (10%);. INACTIVES: Methylcellulose, Purified Water, Sodium Thiosulfate. Sodium Phosphate Monobasic may be added to adjust pH (6.8-8.0). PRESERVATIVES ADDED: Methylparaben 0.05% and Propylparaben 0.01%. The osmolality range is 700-1300 mOsm/kg.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>76420-207-15</NDCCode><ProprietaryName>Sportcaine Patch</ProprietaryName><NonProprietaryName>Lidocaine 4%, Menthol 1%</NonProprietaryName></NDC><NDC><NDCCode>21695-207-15</NDCCode><ProprietaryName>Fluocinonide</ProprietaryName><NonProprietaryName>Fluocinonide</NonProprietaryName></NDC><NDC><NDCCode>42002-207-05</NDCCode><ProprietaryName>Visine Tears</ProprietaryName><NonProprietaryName>Glycerin, Hypromelloses, And Polyethylene Glycol 400</NonProprietaryName></NDC><NDC><NDCCode>51508-207-15</NDCCode><NonProprietaryName>Dutasteride</NonProprietaryName></NDC><NDC><NDCCode>55289-207-15</NDCCode><ProprietaryName>Penicillin V Potassium</ProprietaryName><NonProprietaryName>Penicillin V Potassium</NonProprietaryName></NDC><NDC><NDCCode>61748-207-15</NDCCode><ProprietaryName>Desoximetasone</ProprietaryName><NonProprietaryName>Desoximetasone</NonProprietaryName></NDC><NDC><NDCCode>71073-207-35</NDCCode><ProprietaryName>Gen7t Plus</ProprietaryName><NonProprietaryName>Lidocaine, Menthol</NonProprietaryName></NDC><NDC><NDCCode>71205-207-15</NDCCode><ProprietaryName>Cetirizine Hydrochloride</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71919-207-07</NDCCode><ProprietaryName>Clematis Erecta</ProprietaryName><NonProprietaryName>Clematis Recta Flowering Top</NonProprietaryName></NDC><NDC><NDCCode>75834-207-15</NDCCode><ProprietaryName>Tizanidine Hydrochloride</ProprietaryName><NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76138-207-05</NDCCode><ProprietaryName>5281 Sunscreen</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>76731-207-01</NDCCode><ProprietaryName>Cell 97.7 Re-activated Perfect Lifting Eye Cream</ProprietaryName><NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName></NDC><NDC><NDCCode>83455-207-01</NDCCode><ProprietaryName>Equaline Multi-symptom Eye Drops</ProprietaryName><NonProprietaryName>Polyethylene Glycol 400, Tetrahydrozoline Hcl, Zinc Sulfate</NonProprietaryName></NDC><NDC><NDCCode>84369-207-01</NDCCode><ProprietaryName>Sleep Patch</ProprietaryName><NonProprietaryName>Sleep Patch</NonProprietaryName></NDC><NDC><NDCCode>84515-207-01</NDCCode><ProprietaryName>Hair Growth Oil</ProprietaryName><NonProprietaryName>Hair Growth Oil</NonProprietaryName></NDC><NDC><NDCCode>84525-207-01</NDCCode><ProprietaryName>Trstay Keratin Mask For Dry Damaged Hair</ProprietaryName><NonProprietaryName>Trstay Keratin Mask For Dry Damaged Hair</NonProprietaryName></NDC><NDC><NDCCode>84756-207-01</NDCCode><ProprietaryName>Beard Growth</ProprietaryName><NonProprietaryName>Beard Growth</NonProprietaryName></NDC><NDC><NDCCode>84827-207-01</NDCCode><ProprietaryName>Trstay Turmeric Moisture And</ProprietaryName><NonProprietaryName>Trstay Turmeric Moisture And</NonProprietaryName></NDC><NDC><NDCCode>84864-207-02</NDCCode><ProprietaryName>Eye Cream</ProprietaryName><NonProprietaryName>Eye Cream</NonProprietaryName></NDC><NDC><NDCCode>85766-207-15</NDCCode><ProprietaryName>Mupirocin</ProprietaryName><NonProprietaryName>Mupirocin</NonProprietaryName></NDC><NDC><NDCCode>76420-004-15</NDCCode><ProprietaryName>Anastrozole</ProprietaryName><NonProprietaryName>Anastrozole</NonProprietaryName></NDC><NDC><NDCCode>76420-010-15</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76420-032-15</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>76420-043-15</NDCCode><ProprietaryName>Meloxicam</ProprietaryName><NonProprietaryName>Meloxicam</NonProprietaryName></NDC><NDC><NDCCode>76420-048-29</NDCCode><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>76420-049-35</NDCCode><NonProprietaryName>Estriol</NonProprietaryName></NDC><NDC><NDCCode>76420-050-15</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>76420-069-15</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>76420-076-15</NDCCode><ProprietaryName>Sulfacetamide Sodium</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>76420-090-15</NDCCode><ProprietaryName>Sulfacetamide Sodium</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
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      "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",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
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}
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