RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "35573-314-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-314-10)",
      "NDC11Code": "35573-0314-10",
      "ProductNDC": "35573-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azuphen Mb",
      "NonProprietaryName": "Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150928",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "StrengthNumber": ".12; 120; 10; 36; 40.8",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35573-108-14",
      "PackageDescription": "10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14)  / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13) ",
      "NDC11Code": "35573-0108-14",
      "ProductNDC": "35573-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Polystyrene Sulfonate",
      "NonProprietaryName": "Sodium Polystyrene Sulfonate",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL; RECTAL",
      "StartMarketingDate": "20251218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214912",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
      "StrengthNumber": "15",
      "StrengthUnit": "g/60mL",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Polystyrene Sulfonate Suspension, USP  is indicated for the treatment of hyperkalemia.",
      "Description": "Sodium Polystyrene Sulfonate Suspension, USP can be administered orally or in an enema. It is a suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate, USP) per 60 mL of suspension. Also contains Purified Water, USP; Propylene Glycol, USP; Sodium Saccharin, USP; Methylparaben, NF; Propylparaben, NF; Xanthan Gum, NF; and Citric Acid Anhydrous, USP. Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema."
    },
    {
      "NDCCode": "35573-300-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-300-10)",
      "NDC11Code": "35573-0300-10",
      "ProductNDC": "35573-300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Uramit Mb",
      "NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150626",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE",
      "StrengthNumber": "118; 40.8; 36; 10; .12",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35573-302-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (35573-302-10)",
      "NDC11Code": "35573-0302-10",
      "ProductNDC": "35573-302",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Urolet Mb",
      "NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150626",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "METHENAMINE; SODIUM PHOSPHATE, MONOBASIC; HYOSCYAMINE SULFATE; METHYLENE BLUE",
      "StrengthNumber": "81.6; 40.8; .12; 10.8",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-03"
    },
    {
      "NDCCode": "35573-305-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (35573-305-10) ",
      "NDC11Code": "35573-0305-10",
      "ProductNDC": "35573-305",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hydrochloride",
      "NonProprietaryName": "Phenazopyridine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160222",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231",
      "StartMarketingDatePackage": "20160222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35573-306-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (35573-306-10) ",
      "NDC11Code": "35573-0306-10",
      "ProductNDC": "35573-306",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hydrochloride",
      "NonProprietaryName": "Phenazopyridine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160222",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231",
      "StartMarketingDatePackage": "20160222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35573-307-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (35573-307-10)",
      "NDC11Code": "35573-0307-10",
      "ProductNDC": "35573-307",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Urophen Mb",
      "NonProprietaryName": "Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Benzoic Acid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150928",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; BENZOIC ACID",
      "StrengthNumber": ".12; 81.6; 10.8; 36.2; 9",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35573-311-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-311-10)",
      "NDC11Code": "35573-0311-10",
      "ProductNDC": "35573-311",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isometheptene Mucate, Dichloralphenazone, And Acetaminophen",
      "NonProprietaryName": "Isometheptene Mucate, Dichloralphenazone, And Acetaminophen",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160416",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "ISOMETHEPTENE MUCATE; DICHLORALPHENAZONE; ACETAMINOPHEN",
      "StrengthNumber": "65; 100; 325",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-01"
    },
    {
      "NDCCode": "35573-315-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-315-10)",
      "NDC11Code": "35573-0315-10",
      "ProductNDC": "35573-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Indiomin Mb",
      "NonProprietaryName": "Hyoscyamine Sulfate, Methenamine, Methylene Blue, And Sodium Phosphate, Monobasic, Monohydrate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150928",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "StrengthNumber": ".12; 120; 10; 40.8",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-14",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "35573-325-10",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-325-10)",
      "NDC11Code": "35573-0325-10",
      "ProductNDC": "35573-325",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlordiazepoxide Hydrochloride And Clidinium Bromide",
      "NonProprietaryName": "Chlordiazepoxide Hydrochloride And Clidinium Bromide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160415",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE",
      "StrengthNumber": "5; 2.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-05-17"
    },
    {
      "NDCCode": "35573-329-10",
      "PackageDescription": "285 g in 1 BOTTLE (35573-329-10)",
      "NDC11Code": "35573-0329-10",
      "ProductNDC": "35573-329",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser",
      "NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160314",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Burel Pharmaceuticals, Inc",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "98; 48",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "35573-428-80",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (35573-428-80)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "35573-0428-80",
      "ProductNDC": "35573-428",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium",
      "NonProprietaryName": "Pantoprazole Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200420",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202038",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-02-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200420",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
      "Description": "The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]­-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available as 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets 40 mg complies USP dissolution test 3."
    },
    {
      "NDCCode": "35573-470-75",
      "PackageDescription": "10 TABLET in 1 BOTTLE (35573-470-75) ",
      "NDC11Code": "35573-0470-75",
      "ProductNDC": "35573-470",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milophene",
      "NonProprietaryName": "Clomiphene Citrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250815",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072196",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "CLOMIPHENE CITRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.). Clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below. 1. Patients who are not pregnant. 2. Patients without ovarian cysts. Clomiphene citrate should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate treatment. 3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present. 4. Patients with normal liver function. In addition, patients selected for clomiphene citrate therapy should be evaluated in regard to the following. 1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy. 2. Primary Pituitary or Ovarian Failure. Clomiphene citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure. 3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to clomiphene citrate therapy in this population. 4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility. 5. Uterine Fibroids. Caution should be exercised when using clomiphene citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene citrate is not known. Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation-inducing drugs). Similarly, there is no standard clomiphene citrate regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate is not recommended for these uses.",
      "Description": "Milophene (clomiphene citrate) Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C26H28CINO  C6H 8O7 and a molecular weight of 598.10. It is represented structurally as:. Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white debossed tablet contains 50 mg Milophene (clomiphene citrate) USP. The tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose."
    },
    {
      "NDCCode": "10122-314-10",
      "PackageDescription": "10 CARTON in 1 BOX (10122-314-10)  > 1 BAG in 1 CARTON (10122-314-01)  > 200 mL in 1 BAG",
      "NDC11Code": "10122-0314-10",
      "ProductNDC": "10122-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cardene Iv",
      "NonProprietaryName": "Nicardipine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19920130",
      "EndMarketingDate": "20220630",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019734",
      "LabelerName": "Chiesi USA, Inc.",
      "SubstanceName": "NICARDIPINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19920130",
      "EndMarketingDatePackage": "20220630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "25021-314-10",
      "PackageDescription": "10 VIAL in 1 CARTON (25021-314-10)  > 10 mL in 1 VIAL",
      "NDC11Code": "25021-0314-10",
      "ProductNDC": "25021-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Esmolol Hydrochloride",
      "NonProprietaryName": "Esmolol Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208538",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "ESMOLOL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "29336-314-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (29336-314-10)",
      "NDC11Code": "29336-0314-10",
      "ProductNDC": "29336-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tambocor",
      "NonProprietaryName": "Flecainide Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018830",
      "LabelerName": "Graceway Pharmaceuticals, LLC",
      "SubstanceName": "FLECAINIDE ACETATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-28"
    },
    {
      "NDCCode": "31722-314-10",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (31722-314-10)  / 10 mL in 1 VIAL, MULTI-DOSE (31722-314-02) ",
      "NDC11Code": "31722-0314-10",
      "ProductNDC": "31722-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cisatracurium Besylate",
      "NonProprietaryName": "Cisatracurium Besylate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260504",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212432",
      "LabelerName": "Camber Pharmaceuticals Inc.",
      "SubstanceName": "CISATRACURIUM BESYLATE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260504",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cisatracurium besylate injection is indicated.        as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age.        to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU.        to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. Limitations of Use. Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.",
      "Description": "Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis- cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.48. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of Cisatracurium besylate injection, USP is between 3.30 to 3.40."
    },
    {
      "NDCCode": "33342-314-12",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-314-12)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "33342-0314-12",
      "ProductNDC": "33342-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propylthiouracil",
      "NonProprietaryName": "Propylthiouracil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230510",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208867",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "PROPYLTHIOURACIL",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230510",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propylthiouracil are indicated:  in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option  to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole.",
      "Description": "Propylthiouracil USP is one of the thiocarbamide compounds. It is a white, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil USP is an antithyroid drug administered orally. The structural formula is. Each tablet contains propylthiouracil USP 50 mg and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate and magnesium stearate."
    },
    {
      "NDCCode": "42571-314-89",
      "PackageDescription": "10 CARTON in 1 CARTON (42571-314-89)  / 1 VIAL, GLASS in 1 CARTON (42571-314-88)  / 10 mL in 1 VIAL, GLASS",
      "NDC11Code": "42571-0314-89",
      "ProductNDC": "42571-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tranexamic Acid",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206713",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
      "Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white crystalline powder. The structural formula is. Molecular Formula: C 8H 15NO 2Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid, USP and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0."
    },
    {
      "NDCCode": "42677-314-10",
      "PackageDescription": "10 VIAL in 1 CARTON (42677-314-10)  / 20 mL in 1 VIAL (42677-314-01) ",
      "NDC11Code": "42677-0314-10",
      "ProductNDC": "42677-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Milrinone Lactate",
      "NonProprietaryName": "Milrinone Lactate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216373",
      "LabelerName": "Shandong New Time Pharmaceutical Co., Ltd.",
      "SubstanceName": "MILRINONE LACTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230123",
      "SamplePackage": "N",
      "IndicationAndUsage": "Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone lactate has been in patients receiving digoxin and diuretics.",
      "Description": "Milrinone lactate injection is a member of a class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile lactate and has the following structure. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and an empirical formula of C 12H 9N 3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials:Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously."
    },
    {
      "NDCCode": "42806-314-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42806-314-10) ",
      "NDC11Code": "42806-0314-10",
      "ProductNDC": "42806-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170313",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090564",
      "LabelerName": "Epic Pharma, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "850",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2019-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170313",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each metformin hydrochloride tablet, USP, contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients: povidone (K-30), povidone (K-90), pregelatinized starch, and magnesiium stearate. In addition, the coating for the tablet contains artificial blackberry flavor, hypromellose, macrogol and titanium dioxide."
    },
    {
      "NDCCode": "43744-314-10",
      "PackageDescription": "1 g in 1 DRUM (43744-314-10)",
      "NDC11Code": "43744-0314-10",
      "ProductNDC": "43744-314",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dobutamine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120801",
      "EndMarketingDate": "20130630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130630"
    },
    {
      "NDCCode": "43744-314-15",
      "PackageDescription": "10 g in 1 DRUM (43744-314-15)",
      "NDC11Code": "43744-0314-15",
      "ProductNDC": "43744-314",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dobutamine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120801",
      "EndMarketingDate": "20130630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130630"
    },
    {
      "NDCCode": "47993-314-01",
      "PackageDescription": "10 mL in 1 BOTTLE, SPRAY (47993-314-01) ",
      "NDC11Code": "47993-0314-01",
      "ProductNDC": "47993-314",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Hand Sanitizerspray",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200818",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "g/112mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200818",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses：: 1 For hand sanitizing to reduce bacteria on the skin."
    },
    {
      "NDCCode": "48433-314-10",
      "PackageDescription": "100 POUCH in 1 BOX, UNIT-DOSE (48433-314-10)  > 1 TABLET in 1 POUCH (48433-314-01)",
      "NDC11Code": "48433-0314-10",
      "ProductNDC": "48433-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018569",
      "LabelerName": "Safecor Health, LLC",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "49035-314-10",
      "PackageDescription": "10 LOZENGE in 1 BOX (49035-314-10) ",
      "NDC11Code": "49035-0314-10",
      "ProductNDC": "49035-314",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equate Sore Throat Pops",
      "NonProprietaryName": "Pectin",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190418",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Walmart",
      "SubstanceName": "PECTIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190418",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. For temporary relief relief of minor discomfort and protection of irritated areas in sore mouth and sore throat."
    },
    {
      "NDCCode": "49281-314-15",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-314-15)  / .5 mL in 1 VIAL, SINGLE-DOSE (49281-314-78) ",
      "NDC11Code": "49281-0314-15",
      "ProductNDC": "49281-314",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240304",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240304",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2) and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49643-314-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-314-10) ",
      "NDC11Code": "49643-0314-10",
      "ProductNDC": "49643-314",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Redroot Pigweed Pollen",
      "NonProprietaryName": "Amaranthus Retroflexus",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740312",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102211",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "AMARANTHUS RETROFLEXUS POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19740312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
      "Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
    },
    {
      "NDCCode": "52686-314-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (52686-314-10)  > 35.88 g in 1 BOTTLE",
      "NDC11Code": "52686-0314-10",
      "ProductNDC": "52686-314",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shiseido Radiant Lifting Foundation",
      "ProprietaryNameSuffix": "B20",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120801",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SHISEIDO AMERICA INC.",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "682; 1471",
      "StrengthUnit": "mg/35.88g; mg/35.88g",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20120801",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "53150-314-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (53150-314-10)  > 10 mL in 1 VIAL, SINGLE-DOSE (53150-314-01)",
      "NDC11Code": "53150-0314-10",
      "ProductNDC": "53150-314",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxorubicin Hydrochloride",
      "NonProprietaryName": "Doxorubicin Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200901",
      "LabelerName": "Amneal-Agila, LLC",
      "SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-20",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"35573-314-10","ProprietaryName":"Azuphen Mb","NonProprietaryName":"Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate"},{"NDCCode":"35573-108-14","ProprietaryName":"Sodium Polystyrene Sulfonate","NonProprietaryName":"Sodium Polystyrene Sulfonate"},{"NDCCode":"35573-300-10","ProprietaryName":"Uramit Mb","NonProprietaryName":"Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate"},{"NDCCode":"35573-302-10","ProprietaryName":"Urolet Mb","NonProprietaryName":"Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate"},{"NDCCode":"35573-305-10","ProprietaryName":"Phenazopyridine Hydrochloride","NonProprietaryName":"Phenazopyridine Hydrochloride"},{"NDCCode":"35573-306-10","ProprietaryName":"Phenazopyridine Hydrochloride","NonProprietaryName":"Phenazopyridine Hydrochloride"},{"NDCCode":"35573-307-10","ProprietaryName":"Urophen Mb","NonProprietaryName":"Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Benzoic Acid"},{"NDCCode":"35573-311-10","ProprietaryName":"Isometheptene Mucate, Dichloralphenazone, And Acetaminophen","NonProprietaryName":"Isometheptene Mucate, Dichloralphenazone, And Acetaminophen"},{"NDCCode":"35573-315-10","ProprietaryName":"Indiomin Mb","NonProprietaryName":"Hyoscyamine Sulfate, Methenamine, Methylene Blue, And Sodium Phosphate, Monobasic, Monohydrate"},{"NDCCode":"35573-325-10","ProprietaryName":"Chlordiazepoxide Hydrochloride And Clidinium Bromide","NonProprietaryName":"Chlordiazepoxide Hydrochloride And Clidinium Bromide"},{"NDCCode":"35573-329-10","ProprietaryName":"Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser","NonProprietaryName":"Sodium Sulfacetamide And Sulfur"},{"NDCCode":"35573-428-80","ProprietaryName":"Pantoprazole Sodium","NonProprietaryName":"Pantoprazole Sodium"},{"NDCCode":"35573-470-75","ProprietaryName":"Milophene","NonProprietaryName":"Clomiphene Citrate"},{"NDCCode":"10122-314-10","ProprietaryName":"Cardene Iv","NonProprietaryName":"Nicardipine Hydrochloride"},{"NDCCode":"25021-314-10","ProprietaryName":"Esmolol Hydrochloride","NonProprietaryName":"Esmolol Hydrochloride"},{"NDCCode":"29336-314-10","ProprietaryName":"Tambocor","NonProprietaryName":"Flecainide Acetate"},{"NDCCode":"31722-314-10","ProprietaryName":"Cisatracurium Besylate","NonProprietaryName":"Cisatracurium Besylate"},{"NDCCode":"33342-314-12","ProprietaryName":"Propylthiouracil","NonProprietaryName":"Propylthiouracil"},{"NDCCode":"42571-314-89","ProprietaryName":"Tranexamic Acid","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"42677-314-10","ProprietaryName":"Milrinone Lactate","NonProprietaryName":"Milrinone Lactate"},{"NDCCode":"42806-314-10","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"43744-314-10","NonProprietaryName":"Dobutamine Hydrochloride"},{"NDCCode":"43744-314-15","NonProprietaryName":"Dobutamine Hydrochloride"},{"NDCCode":"47993-314-01","ProprietaryName":"Antibacterial Hand Sanitizerspray","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"48433-314-10","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"49035-314-10","ProprietaryName":"Equate Sore Throat Pops","NonProprietaryName":"Pectin"},{"NDCCode":"49281-314-15","ProprietaryName":"Fluzone Northern Hemisphere","NonProprietaryName":"Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)"},{"NDCCode":"49643-314-10","ProprietaryName":"Redroot Pigweed Pollen","NonProprietaryName":"Amaranthus Retroflexus"},{"NDCCode":"52686-314-10","ProprietaryName":"Shiseido Radiant Lifting Foundation","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"53150-314-10","ProprietaryName":"Doxorubicin Hydrochloride","NonProprietaryName":"Doxorubicin Hydrochloride"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>35573-314-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (35573-314-10)</PackageDescription>
    <NDC11Code>35573-0314-10</NDC11Code>
    <ProductNDC>35573-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azuphen Mb</ProprietaryName>
    <NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150928</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
    <StrengthNumber>.12; 120; 10; 36; 40.8</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>35573-108-14</NDCCode>
    <PackageDescription>10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14)  / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13) </PackageDescription>
    <NDC11Code>35573-0108-14</NDC11Code>
    <ProductNDC>35573-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
    <NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL; RECTAL</RouteName>
    <StartMarketingDate>20251218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214912</ApplicationNumber>
    <LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>g/60mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Polystyrene Sulfonate Suspension, USP  is indicated for the treatment of hyperkalemia.</IndicationAndUsage>
    <Description>Sodium Polystyrene Sulfonate Suspension, USP can be administered orally or in an enema. It is a suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate, USP) per 60 mL of suspension. Also contains Purified Water, USP; Propylene Glycol, USP; Sodium Saccharin, USP; Methylparaben, NF; Propylparaben, NF; Xanthan Gum, NF; and Citric Acid Anhydrous, USP. Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.</Description>
  </NDC>
  <NDC>
    <NDCCode>35573-300-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (35573-300-10)</PackageDescription>
    <NDC11Code>35573-0300-10</NDC11Code>
    <ProductNDC>35573-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Uramit Mb</ProprietaryName>
    <NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150626</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE</SubstanceName>
    <StrengthNumber>118; 40.8; 36; 10; .12</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>35573-302-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (35573-302-10)</PackageDescription>
    <NDC11Code>35573-0302-10</NDC11Code>
    <ProductNDC>35573-302</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Urolet Mb</ProprietaryName>
    <NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150626</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>METHENAMINE; SODIUM PHOSPHATE, MONOBASIC; HYOSCYAMINE SULFATE; METHYLENE BLUE</SubstanceName>
    <StrengthNumber>81.6; 40.8; .12; 10.8</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35573-305-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (35573-305-10) </PackageDescription>
    <NDC11Code>35573-0305-10</NDC11Code>
    <ProductNDC>35573-305</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160222</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>35573-306-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (35573-306-10) </PackageDescription>
    <NDC11Code>35573-0306-10</NDC11Code>
    <ProductNDC>35573-306</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160222</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>35573-307-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (35573-307-10)</PackageDescription>
    <NDC11Code>35573-0307-10</NDC11Code>
    <ProductNDC>35573-307</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Urophen Mb</ProprietaryName>
    <NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Benzoic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150928</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; BENZOIC ACID</SubstanceName>
    <StrengthNumber>.12; 81.6; 10.8; 36.2; 9</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>35573-311-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (35573-311-10)</PackageDescription>
    <NDC11Code>35573-0311-10</NDC11Code>
    <ProductNDC>35573-311</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isometheptene Mucate, Dichloralphenazone, And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Isometheptene Mucate, Dichloralphenazone, And Acetaminophen</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160416</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>ISOMETHEPTENE MUCATE; DICHLORALPHENAZONE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>65; 100; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35573-315-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (35573-315-10)</PackageDescription>
    <NDC11Code>35573-0315-10</NDC11Code>
    <ProductNDC>35573-315</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Indiomin Mb</ProprietaryName>
    <NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150928</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
    <StrengthNumber>.12; 120; 10; 40.8</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-14</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>35573-325-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (35573-325-10)</PackageDescription>
    <NDC11Code>35573-0325-10</NDC11Code>
    <ProductNDC>35573-325</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlordiazepoxide Hydrochloride And Clidinium Bromide</ProprietaryName>
    <NonProprietaryName>Chlordiazepoxide Hydrochloride And Clidinium Bromide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160415</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE</SubstanceName>
    <StrengthNumber>5; 2.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-05-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35573-329-10</NDCCode>
    <PackageDescription>285 g in 1 BOTTLE (35573-329-10)</PackageDescription>
    <NDC11Code>35573-0329-10</NDC11Code>
    <ProductNDC>35573-329</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser</ProprietaryName>
    <NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160314</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>98; 48</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35573-428-80</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (35573-428-80)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>35573-0428-80</NDC11Code>
    <ProductNDC>35573-428</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200420</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202038</ApplicationNumber>
    <LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium delayed-release tablets, USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]­-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available as 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets 40 mg complies USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>35573-470-75</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (35573-470-75) </PackageDescription>
    <NDC11Code>35573-0470-75</NDC11Code>
    <ProductNDC>35573-470</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Milophene</ProprietaryName>
    <NonProprietaryName>Clomiphene Citrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA072196</ApplicationNumber>
    <LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CLOMIPHENE CITRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.). Clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below. 1. Patients who are not pregnant. 2. Patients without ovarian cysts. Clomiphene citrate should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate treatment. 3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present. 4. Patients with normal liver function. In addition, patients selected for clomiphene citrate therapy should be evaluated in regard to the following. 1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy. 2. Primary Pituitary or Ovarian Failure. Clomiphene citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure. 3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to clomiphene citrate therapy in this population. 4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility. 5. Uterine Fibroids. Caution should be exercised when using clomiphene citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene citrate is not known. Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation-inducing drugs). Similarly, there is no standard clomiphene citrate regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate is not recommended for these uses.</IndicationAndUsage>
    <Description>Milophene (clomiphene citrate) Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C26H28CINO  C6H 8O7 and a molecular weight of 598.10. It is represented structurally as:. Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white debossed tablet contains 50 mg Milophene (clomiphene citrate) USP. The tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>10122-314-10</NDCCode>
    <PackageDescription>10 CARTON in 1 BOX (10122-314-10)  &gt; 1 BAG in 1 CARTON (10122-314-01)  &gt; 200 mL in 1 BAG</PackageDescription>
    <NDC11Code>10122-0314-10</NDC11Code>
    <ProductNDC>10122-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cardene Iv</ProprietaryName>
    <NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19920130</StartMarketingDate>
    <EndMarketingDate>20220630</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019734</ApplicationNumber>
    <LabelerName>Chiesi USA, Inc.</LabelerName>
    <SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19920130</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>25021-314-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (25021-314-10)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0314-10</NDC11Code>
    <ProductNDC>25021-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Esmolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Esmolol Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208538</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>ESMOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>29336-314-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (29336-314-10)</PackageDescription>
    <NDC11Code>29336-0314-10</NDC11Code>
    <ProductNDC>29336-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tambocor</ProprietaryName>
    <NonProprietaryName>Flecainide Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070401</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018830</ApplicationNumber>
    <LabelerName>Graceway Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>FLECAINIDE ACETATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-07-28</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>31722-314-10</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (31722-314-10)  / 10 mL in 1 VIAL, MULTI-DOSE (31722-314-02) </PackageDescription>
    <NDC11Code>31722-0314-10</NDC11Code>
    <ProductNDC>31722-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cisatracurium Besylate</ProprietaryName>
    <NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260504</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212432</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260504</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cisatracurium besylate injection is indicated.        as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age.        to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU.        to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. Limitations of Use. Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.</IndicationAndUsage>
    <Description>Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis- cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.48. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of Cisatracurium besylate injection, USP is between 3.30 to 3.40.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-314-12</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-314-12)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0314-12</NDC11Code>
    <ProductNDC>33342-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propylthiouracil</ProprietaryName>
    <NonProprietaryName>Propylthiouracil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230510</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208867</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PROPYLTHIOURACIL</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propylthiouracil are indicated:  in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option  to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole.</IndicationAndUsage>
    <Description>Propylthiouracil USP is one of the thiocarbamide compounds. It is a white, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil USP is an antithyroid drug administered orally. The structural formula is. Each tablet contains propylthiouracil USP 50 mg and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-314-89</NDCCode>
    <PackageDescription>10 CARTON in 1 CARTON (42571-314-89)  / 1 VIAL, GLASS in 1 CARTON (42571-314-88)  / 10 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>42571-0314-89</NDC11Code>
    <ProductNDC>42571-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tranexamic Acid</ProprietaryName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206713</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
    <Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white crystalline powder. The structural formula is. Molecular Formula: C 8H 15NO 2Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid, USP and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>42677-314-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (42677-314-10)  / 20 mL in 1 VIAL (42677-314-01) </PackageDescription>
    <NDC11Code>42677-0314-10</NDC11Code>
    <ProductNDC>42677-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Milrinone Lactate</ProprietaryName>
    <NonProprietaryName>Milrinone Lactate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216373</ApplicationNumber>
    <LabelerName>Shandong New Time Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>MILRINONE LACTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone lactate has been in patients receiving digoxin and diuretics.</IndicationAndUsage>
    <Description>Milrinone lactate injection is a member of a class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile lactate and has the following structure. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and an empirical formula of C 12H 9N 3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials:Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-314-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42806-314-10) </PackageDescription>
    <NDC11Code>42806-0314-10</NDC11Code>
    <ProductNDC>42806-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170313</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090564</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>850</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each metformin hydrochloride tablet, USP, contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients: povidone (K-30), povidone (K-90), pregelatinized starch, and magnesiium stearate. In addition, the coating for the tablet contains artificial blackberry flavor, hypromellose, macrogol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43744-314-10</NDCCode>
    <PackageDescription>1 g in 1 DRUM (43744-314-10)</PackageDescription>
    <NDC11Code>43744-0314-10</NDC11Code>
    <ProductNDC>43744-314</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dobutamine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120801</StartMarketingDate>
    <EndMarketingDate>20130630</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-314-15</NDCCode>
    <PackageDescription>10 g in 1 DRUM (43744-314-15)</PackageDescription>
    <NDC11Code>43744-0314-15</NDC11Code>
    <ProductNDC>43744-314</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dobutamine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120801</StartMarketingDate>
    <EndMarketingDate>20130630</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>47993-314-01</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE, SPRAY (47993-314-01) </PackageDescription>
    <NDC11Code>47993-0314-01</NDC11Code>
    <ProductNDC>47993-314</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Hand Sanitizerspray</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200818</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>g/112mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200818</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses：: 1 For hand sanitizing to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48433-314-10</NDCCode>
    <PackageDescription>100 POUCH in 1 BOX, UNIT-DOSE (48433-314-10)  &gt; 1 TABLET in 1 POUCH (48433-314-01)</PackageDescription>
    <NDC11Code>48433-0314-10</NDC11Code>
    <ProductNDC>48433-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140930</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018569</ApplicationNumber>
    <LabelerName>Safecor Health, LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-26</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49035-314-10</NDCCode>
    <PackageDescription>10 LOZENGE in 1 BOX (49035-314-10) </PackageDescription>
    <NDC11Code>49035-0314-10</NDC11Code>
    <ProductNDC>49035-314</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equate Sore Throat Pops</ProprietaryName>
    <NonProprietaryName>Pectin</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190418</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Walmart</LabelerName>
    <SubstanceName>PECTIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190418</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. For temporary relief relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49281-314-15</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-314-15)  / .5 mL in 1 VIAL, SINGLE-DOSE (49281-314-78) </PackageDescription>
    <NDC11Code>49281-0314-15</NDC11Code>
    <ProductNDC>49281-314</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20240304</StartMarketingDate>
    <EndMarketingDate>20240630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240304</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.</IndicationAndUsage>
    <Description>Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2) and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
  </NDC>
  <NDC>
    <NDCCode>49643-314-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-314-10) </PackageDescription>
    <NDC11Code>49643-0314-10</NDC11Code>
    <ProductNDC>49643-314</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Redroot Pigweed Pollen</ProprietaryName>
    <NonProprietaryName>Amaranthus Retroflexus</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740312</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102211</ApplicationNumber>
    <LabelerName>Allermed Laboratories, Inc.</LabelerName>
    <SubstanceName>AMARANTHUS RETROFLEXUS POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19740312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
    <Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
  </NDC>
  <NDC>
    <NDCCode>52686-314-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (52686-314-10)  &gt; 35.88 g in 1 BOTTLE</PackageDescription>
    <NDC11Code>52686-0314-10</NDC11Code>
    <ProductNDC>52686-314</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shiseido Radiant Lifting Foundation</ProprietaryName>
    <ProprietaryNameSuffix>B20</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SHISEIDO AMERICA INC.</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>682; 1471</StrengthNumber>
    <StrengthUnit>mg/35.88g; mg/35.88g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>53150-314-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (53150-314-10)  &gt; 10 mL in 1 VIAL, SINGLE-DOSE (53150-314-01)</PackageDescription>
    <NDC11Code>53150-0314-10</NDC11Code>
    <ProductNDC>53150-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200901</ApplicationNumber>
    <LabelerName>Amneal-Agila, LLC</LabelerName>
    <SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-20</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>35573-314-10</NDCCode><ProprietaryName>Azuphen Mb</ProprietaryName><NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>35573-108-14</NDCCode><ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName><NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName></NDC><NDC><NDCCode>35573-300-10</NDCCode><ProprietaryName>Uramit Mb</ProprietaryName><NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35573-302-10</NDCCode><ProprietaryName>Urolet Mb</ProprietaryName><NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35573-305-10</NDCCode><ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName><NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35573-306-10</NDCCode><ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName><NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35573-307-10</NDCCode><ProprietaryName>Urophen Mb</ProprietaryName><NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Benzoic Acid</NonProprietaryName></NDC><NDC><NDCCode>35573-311-10</NDCCode><ProprietaryName>Isometheptene Mucate, Dichloralphenazone, And Acetaminophen</ProprietaryName><NonProprietaryName>Isometheptene Mucate, Dichloralphenazone, And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>35573-315-10</NDCCode><ProprietaryName>Indiomin Mb</ProprietaryName><NonProprietaryName>Hyoscyamine Sulfate, Methenamine, Methylene Blue, And Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>35573-325-10</NDCCode><ProprietaryName>Chlordiazepoxide Hydrochloride And Clidinium Bromide</ProprietaryName><NonProprietaryName>Chlordiazepoxide Hydrochloride And Clidinium Bromide</NonProprietaryName></NDC><NDC><NDCCode>35573-329-10</NDCCode><ProprietaryName>Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser</ProprietaryName><NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName></NDC><NDC><NDCCode>35573-428-80</NDCCode><ProprietaryName>Pantoprazole Sodium</ProprietaryName><NonProprietaryName>Pantoprazole Sodium</NonProprietaryName></NDC><NDC><NDCCode>35573-470-75</NDCCode><ProprietaryName>Milophene</ProprietaryName><NonProprietaryName>Clomiphene Citrate</NonProprietaryName></NDC><NDC><NDCCode>10122-314-10</NDCCode><ProprietaryName>Cardene Iv</ProprietaryName><NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>25021-314-10</NDCCode><ProprietaryName>Esmolol Hydrochloride</ProprietaryName><NonProprietaryName>Esmolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>29336-314-10</NDCCode><ProprietaryName>Tambocor</ProprietaryName><NonProprietaryName>Flecainide Acetate</NonProprietaryName></NDC><NDC><NDCCode>31722-314-10</NDCCode><ProprietaryName>Cisatracurium Besylate</ProprietaryName><NonProprietaryName>Cisatracurium Besylate</NonProprietaryName></NDC><NDC><NDCCode>33342-314-12</NDCCode><ProprietaryName>Propylthiouracil</ProprietaryName><NonProprietaryName>Propylthiouracil</NonProprietaryName></NDC><NDC><NDCCode>42571-314-89</NDCCode><ProprietaryName>Tranexamic Acid</ProprietaryName><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>42677-314-10</NDCCode><ProprietaryName>Milrinone Lactate</ProprietaryName><NonProprietaryName>Milrinone Lactate</NonProprietaryName></NDC><NDC><NDCCode>42806-314-10</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43744-314-10</NDCCode><NonProprietaryName>Dobutamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43744-314-15</NDCCode><NonProprietaryName>Dobutamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>47993-314-01</NDCCode><ProprietaryName>Antibacterial Hand Sanitizerspray</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>48433-314-10</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>49035-314-10</NDCCode><ProprietaryName>Equate Sore Throat Pops</ProprietaryName><NonProprietaryName>Pectin</NonProprietaryName></NDC><NDC><NDCCode>49281-314-15</NDCCode><ProprietaryName>Fluzone Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49643-314-10</NDCCode><ProprietaryName>Redroot Pigweed Pollen</ProprietaryName><NonProprietaryName>Amaranthus Retroflexus</NonProprietaryName></NDC><NDC><NDCCode>52686-314-10</NDCCode><ProprietaryName>Shiseido Radiant Lifting Foundation</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>53150-314-10</NDCCode><ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName><NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
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      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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