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How to Find 69918-901-12 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "69918-901-12",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-12)  / 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "69918-0901-12",
      "ProductNDC": "69918-901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220509",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018938",
      "LabelerName": "Nordic Pharma, Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220509",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
      "Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
    },
    {
      "NDCCode": "69918-700-12",
      "PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-12)  / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) ",
      "NDC11Code": "69918-0700-12",
      "ProductNDC": "69918-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Succinylcholine Chloride",
      "NonProprietaryName": "Succinylcholine Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20240520",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216003",
      "LabelerName": "Nordic Pharma, Inc.",
      "SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240520",
      "SamplePackage": "N",
      "IndicationAndUsage": "Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
      "Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4.2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is 2,2’-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white or almost white, odorless, crystalline powder, freely soluble in water. It has the following structural formula. Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of Succinylcholine Chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.8 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
    },
    {
      "NDCCode": "69918-901-10",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-10)  / 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "69918-0901-10",
      "ProductNDC": "69918-901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20160120",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018938",
      "LabelerName": "Nordic Pharma, Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160120",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
      "Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
    },
    {
      "NDCCode": "69918-901-11",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-11)  / 10 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "69918-0901-11",
      "ProductNDC": "69918-901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220107",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018938",
      "LabelerName": "Nordic Pharma, Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": "4",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220107",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
      "Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
    },
    {
      "NDCCode": "10122-901-12",
      "PackageDescription": "120 TABLET in 1 BOTTLE (10122-901-12) ",
      "NDC11Code": "10122-0901-12",
      "ProductNDC": "10122-901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zyflo",
      "NonProprietaryName": "Zileuton",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961206",
      "EndMarketingDate": "20271130",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020471",
      "LabelerName": "Chiesi USA, Inc.",
      "SubstanceName": "ZILEUTON",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]",
      "Status": "Active",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19961206",
      "EndMarketingDatePackage": "20271130",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.",
      "Description": "Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure. Zileuton has the molecular formula C11H12N2O2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is a practically odorless, white, crystalline powder that is soluble in methanol and ethanol, slightly soluble in acetonitrile, and practically insoluble in water and hexane. The melting point ranges from 144.2˚C to 145.2˚C. ZYFLO tablets for oral administration are supplied in one dosage strength containing 600 mg of zileuton. Inactive Ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "15127-901-24",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (15127-901-24)  *  12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK *  12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "15127-0901-24",
      "ProductNDC": "15127-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold And Flu",
      "ProprietaryNameSuffix": "Daytime Nighttime",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20070919",
      "EndMarketingDate": "20180727",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "L&R Distributors, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-30",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "37808-901-12",
      "PackageDescription": "355 mL in 1 BOTTLE (37808-901-12) ",
      "NDC11Code": "37808-0901-12",
      "ProductNDC": "37808-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Milk Of Magnesia",
      "NonProprietaryName": "Magnesium Hydroxide",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "H E B",
      "SubstanceName": "MAGNESIUM HYDROXIDE",
      "StrengthNumber": "1200",
      "StrengthUnit": "mg/15mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2023-11-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200801",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 1/2 to 6 hours."
    },
    {
      "NDCCode": "43538-901-12",
      "PackageDescription": "1 KIT in 1 CARTON (43538-901-12)  *  255 g in 1 TUBE *  1 TUBE in 1 CARTON > 120 g in 1 TUBE",
      "NDC11Code": "43538-0901-12",
      "ProductNDC": "43538-901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Synalar",
      "NonProprietaryName": "Fluocinolone Acetonide",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA012787",
      "LabelerName": "Medimetriks Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20121215",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49035-901-08",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (49035-901-08)  / 12 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "49035-0901-08",
      "ProductNDC": "49035-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900315",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19900315",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing."
    },
    {
      "NDCCode": "49035-901-12",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (49035-901-12)  / 100 CAPSULE in 1 BOTTLE, PLASTIC",
      "NDC11Code": "49035-0901-12",
      "ProductNDC": "49035-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900315",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19900315",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing."
    },
    {
      "NDCCode": "49035-901-42",
      "PackageDescription": "12 CAPSULE in 1 BLISTER PACK (49035-901-42) ",
      "NDC11Code": "49035-0901-42",
      "ProductNDC": "49035-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900315",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19900315",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing."
    },
    {
      "NDCCode": "52985-901-09",
      "PackageDescription": "12 BOTTLE in 1 BOX (52985-901-09)  > 1000 mL in 1 BOTTLE",
      "NDC11Code": "52985-0901-09",
      "ProductNDC": "52985-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Anhui Oasis Disinfection Products Co., Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the hands To help decrease bacteria on the skin when water, soap and towel are not available."
    },
    {
      "NDCCode": "52985-901-12",
      "PackageDescription": "500 BOTTLE in 1 BOX (52985-901-12)  > 15 mL in 1 BOTTLE",
      "NDC11Code": "52985-0901-12",
      "ProductNDC": "52985-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200618",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Anhui Oasis Disinfection Products Co., Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the hands To help decrease bacteria on the skin when water, soap and towel are not available."
    },
    {
      "NDCCode": "61444-901-12",
      "PackageDescription": "100 g in 1 BOTTLE, GLASS (61444-901-12) ",
      "NDC11Code": "61444-0901-12",
      "ProductNDC": "61444-901",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Urea C-13",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "StartMarketingDate": "19960208",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Cambridge Isotope Laboratories, Inc.",
      "SubstanceName": "UREA C-13",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-06-14",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "08-FEB-96"
    },
    {
      "NDCCode": "63029-901-01",
      "PackageDescription": "3 BLISTER PACK in 1 BOX (63029-901-01)  / 12 TABLET in 1 BLISTER PACK",
      "NDC11Code": "63029-0901-01",
      "ProductNDC": "63029-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dramamine Original Formula",
      "NonProprietaryName": "Dimenhydrinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "Medtech Products Inc.",
      "SubstanceName": "DIMENHYDRINATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120115",
      "SamplePackage": "N",
      "IndicationAndUsage": "for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness."
    },
    {
      "NDCCode": "63029-901-02",
      "PackageDescription": "1 BOTTLE in 1 BOX (63029-901-02)  / 12 TABLET in 1 BOTTLE",
      "NDC11Code": "63029-0901-02",
      "ProductNDC": "63029-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dramamine Original Formula",
      "NonProprietaryName": "Dimenhydrinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M009",
      "LabelerName": "Medtech Products Inc.",
      "SubstanceName": "DIMENHYDRINATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120115",
      "SamplePackage": "N",
      "IndicationAndUsage": "for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness."
    },
    {
      "NDCCode": "68428-901-12",
      "PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-901-12)",
      "NDC11Code": "68428-0901-12",
      "ProductNDC": "68428-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cadmium Bromatum",
      "NonProprietaryName": "Cadmium Bromide",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100615",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "CADMIUM BROMIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-22",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "69693-901-04",
      "PackageDescription": "12.4 mL in 1 BOTTLE, DROPPER (69693-901-04) ",
      "NDC11Code": "69693-0901-04",
      "ProductNDC": "69693-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine",
      "NonProprietaryName": "Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20250217",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Clarion Brands LLC",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250217",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of pain."
    },
    {
      "NDCCode": "69898-901-12",
      "PackageDescription": "354 mL in 1 BOTTLE, PLASTIC (69898-901-12) ",
      "NDC11Code": "69898-0901-12",
      "ProductNDC": "69898-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Premium Hand Sanitizer",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200805",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "MD Science Lab LLC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200805",
      "SamplePackage": "N",
      "IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "75111-901-04",
      "PackageDescription": "12 TABLET in 1 BAG (75111-901-04) ",
      "NDC11Code": "75111-0901-04",
      "ProductNDC": "75111-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Effervescent Hand Sanitizer",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Enping Jiaxin Daily Necessities Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "1/1001",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Disposable Effervescent Tablets Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75111-901-12",
      "PackageDescription": "10 TABLET in 1 BOX (75111-901-12) ",
      "NDC11Code": "75111-0901-12",
      "ProductNDC": "75111-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Effervescent Hand Sanitizer",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Enping Jiaxin Daily Necessities Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "1/1001",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Disposable Effervescent Tablets Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75111-901-13",
      "PackageDescription": "12 TABLET in 1 BOX (75111-901-13) ",
      "NDC11Code": "75111-0901-13",
      "ProductNDC": "75111-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Effervescent Hand Sanitizer",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "TABLET",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Enping Jiaxin Daily Necessities Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "1/1001",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Disposable Effervescent Tablets Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "77095-901-12",
      "PackageDescription": "13680 mL in 1 BOTTLE, PUMP (77095-901-12) ",
      "NDC11Code": "77095-0901-12",
      "ProductNDC": "77095-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natezone Hand Sanitizer",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200706",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "U.S. FEDERAL PHARMACEUTICAL FIRM, INC.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "90010-901-12",
      "PackageDescription": "13680 mL in 1 BOTTLE, PUMP (90010-901-12) ",
      "NDC11Code": "90010-0901-12",
      "ProductNDC": "90010-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Natezone Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200807",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Guangzhou Cluster Mapping Supply Chain Co., Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200807",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "69918-101-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69918-101-01)  / 100 TABLET in 1 BOTTLE",
      "NDC11Code": "69918-0101-01",
      "ProductNDC": "69918-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019955",
      "LabelerName": "Nordic Pharma, Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-12-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Central Diabetes Insipidus: Desmopressin Acetate Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.",
      "Description": "Desmopressin Acetate Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:. Mol. Wt. 1183.34 Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Acetate Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone."
    },
    {
      "NDCCode": "69918-201-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69918-201-01)  / 100 TABLET in 1 BOTTLE",
      "NDC11Code": "69918-0201-01",
      "ProductNDC": "69918-201",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desmopressin Acetate",
      "NonProprietaryName": "Desmopressin Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019955",
      "LabelerName": "Nordic Pharma, Inc.",
      "SubstanceName": "DESMOPRESSIN ACETATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-12-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Central Diabetes Insipidus: Desmopressin Acetate Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.",
      "Description": "Desmopressin Acetate Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:. Mol. Wt. 1183.34 Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Acetate Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone."
    },
    {
      "NDCCode": "69918-560-30",
      "PackageDescription": "30 SUPPOSITORY in 1 BOX (69918-560-30) ",
      "NDC11Code": "69918-0560-30",
      "ProductNDC": "69918-560",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mesalamine Rectal",
      "NonProprietaryName": "Mesalamine",
      "DosageFormName": "SUPPOSITORY",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20190624",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208362",
      "LabelerName": "Amring Pharmaceuticals Inc.",
      "SubstanceName": "MESALAMINE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
      "Status": "Active",
      "LastUpdate": "2023-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190624",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mesalamine Rectal Suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.",
      "Description": "The active ingredient in Mesalamine Rectal Suppository 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5- aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each Mesalamine Rectal Suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF. The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is."
    },
    {
      "NDCCode": "10345-901-15",
      "PackageDescription": "1 TUBE in 1 BOX (10345-901-15)  / 15 mL in 1 TUBE",
      "NDC11Code": "10345-0901-15",
      "ProductNDC": "10345-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Erborian - Bb Creme Au Ginseng Dore Spf 20",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150206",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "LABORATOIRES M&L",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "30; 62.8; 19.2",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Active",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "10345-901-45",
      "PackageDescription": "1 TUBE in 1 BOX (10345-901-45)  / 45 mL in 1 TUBE",
      "NDC11Code": "10345-0901-45",
      "ProductNDC": "10345-901",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Erborian - Bb Creme Au Ginseng Dore Spf 20",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150206",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "LABORATOIRES M&L",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "30; 62.8; 19.2",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Active",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "10544-901-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (10544-901-60)",
      "NDC11Code": "10544-0901-60",
      "ProductNDC": "10544-901",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150327",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077064",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg or 850 mg or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and sodium starch glycolate. Metformin hydrochloride extended-release tablets contain 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets 500 mg and 750 mg contain the inactive ingredients glyceryl behenate, hypromellose, microcrystalline cellulose and povidone."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"69918-901-12","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"69918-700-12","ProprietaryName":"Succinylcholine Chloride","NonProprietaryName":"Succinylcholine Chloride"},{"NDCCode":"69918-901-10","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"69918-901-11","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"10122-901-12","ProprietaryName":"Zyflo","NonProprietaryName":"Zileuton"},{"NDCCode":"15127-901-24","ProprietaryName":"Cold And Flu","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate"},{"NDCCode":"37808-901-12","ProprietaryName":"Milk Of Magnesia","NonProprietaryName":"Magnesium Hydroxide"},{"NDCCode":"43538-901-12","ProprietaryName":"Synalar","NonProprietaryName":"Fluocinolone Acetonide"},{"NDCCode":"49035-901-08","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"49035-901-12","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"49035-901-42","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"52985-901-09","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"52985-901-12","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"61444-901-12","NonProprietaryName":"Urea C-13"},{"NDCCode":"63029-901-01","ProprietaryName":"Dramamine Original Formula","NonProprietaryName":"Dimenhydrinate"},{"NDCCode":"63029-901-02","ProprietaryName":"Dramamine Original Formula","NonProprietaryName":"Dimenhydrinate"},{"NDCCode":"68428-901-12","ProprietaryName":"Cadmium Bromatum","NonProprietaryName":"Cadmium Bromide"},{"NDCCode":"69693-901-04","ProprietaryName":"Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine","NonProprietaryName":"Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine"},{"NDCCode":"69898-901-12","ProprietaryName":"Premium Hand Sanitizer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"75111-901-04","ProprietaryName":"Effervescent Hand Sanitizer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"75111-901-12","ProprietaryName":"Effervescent Hand Sanitizer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"75111-901-13","ProprietaryName":"Effervescent Hand Sanitizer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"77095-901-12","ProprietaryName":"Natezone Hand Sanitizer","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"90010-901-12","ProprietaryName":"Natezone Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"69918-101-01","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"69918-201-01","ProprietaryName":"Desmopressin Acetate","NonProprietaryName":"Desmopressin Acetate"},{"NDCCode":"69918-560-30","ProprietaryName":"Mesalamine Rectal","NonProprietaryName":"Mesalamine"},{"NDCCode":"10345-901-15","ProprietaryName":"Erborian - Bb Creme Au Ginseng Dore Spf 20","NonProprietaryName":"Octinoxate, Titanium Dioxide, Zinc Oxide"},{"NDCCode":"10345-901-45","ProprietaryName":"Erborian - Bb Creme Au Ginseng Dore Spf 20","NonProprietaryName":"Octinoxate, Titanium Dioxide, Zinc Oxide"},{"NDCCode":"10544-901-60","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>69918-901-12</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-12)  / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>69918-0901-12</NDC11Code>
    <ProductNDC>69918-901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220509</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018938</ApplicationNumber>
    <LabelerName>Nordic Pharma, Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220509</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
    <Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>69918-700-12</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-12)  / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) </PackageDescription>
    <NDC11Code>69918-0700-12</NDC11Code>
    <ProductNDC>69918-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Succinylcholine Chloride</ProprietaryName>
    <NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20240520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216003</ApplicationNumber>
    <LabelerName>Nordic Pharma, Inc.</LabelerName>
    <SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4.2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is 2,2’-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white or almost white, odorless, crystalline powder, freely soluble in water. It has the following structural formula. Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of Succinylcholine Chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.8 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
  </NDC>
  <NDC>
    <NDCCode>69918-901-10</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-10)  / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>69918-0901-10</NDC11Code>
    <ProductNDC>69918-901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160120</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018938</ApplicationNumber>
    <LabelerName>Nordic Pharma, Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
    <Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>69918-901-11</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-11)  / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>69918-0901-11</NDC11Code>
    <ProductNDC>69918-901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220107</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018938</ApplicationNumber>
    <LabelerName>Nordic Pharma, Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
    <Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>10122-901-12</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (10122-901-12) </PackageDescription>
    <NDC11Code>10122-0901-12</NDC11Code>
    <ProductNDC>10122-901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zyflo</ProprietaryName>
    <NonProprietaryName>Zileuton</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19961206</StartMarketingDate>
    <EndMarketingDate>20271130</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020471</ApplicationNumber>
    <LabelerName>Chiesi USA, Inc.</LabelerName>
    <SubstanceName>ZILEUTON</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19961206</StartMarketingDatePackage>
    <EndMarketingDatePackage>20271130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.</IndicationAndUsage>
    <Description>Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure. Zileuton has the molecular formula C11H12N2O2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is a practically odorless, white, crystalline powder that is soluble in methanol and ethanol, slightly soluble in acetonitrile, and practically insoluble in water and hexane. The melting point ranges from 144.2˚C to 145.2˚C. ZYFLO tablets for oral administration are supplied in one dosage strength containing 600 mg of zileuton. Inactive Ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>15127-901-24</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (15127-901-24)  *  12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK *  12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>15127-0901-24</NDC11Code>
    <ProductNDC>15127-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold And Flu</ProprietaryName>
    <ProprietaryNameSuffix>Daytime Nighttime</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20070919</StartMarketingDate>
    <EndMarketingDate>20180727</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>L&amp;R Distributors, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-30</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>37808-901-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (37808-901-12) </PackageDescription>
    <NDC11Code>37808-0901-12</NDC11Code>
    <ProductNDC>37808-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Milk Of Magnesia</ProprietaryName>
    <NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>H E B</LabelerName>
    <SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
    <StrengthNumber>1200</StrengthNumber>
    <StrengthUnit>mg/15mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43538-901-12</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (43538-901-12)  *  255 g in 1 TUBE *  1 TUBE in 1 CARTON &gt; 120 g in 1 TUBE</PackageDescription>
    <NDC11Code>43538-0901-12</NDC11Code>
    <ProductNDC>43538-901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Synalar</ProprietaryName>
    <NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA012787</ApplicationNumber>
    <LabelerName>Medimetriks Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49035-901-08</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (49035-901-08)  / 12 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>49035-0901-08</NDC11Code>
    <ProductNDC>49035-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900315</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49035-901-12</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (49035-901-12)  / 100 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>49035-0901-12</NDC11Code>
    <ProductNDC>49035-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900315</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49035-901-42</NDCCode>
    <PackageDescription>12 CAPSULE in 1 BLISTER PACK (49035-901-42) </PackageDescription>
    <NDC11Code>49035-0901-42</NDC11Code>
    <ProductNDC>49035-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900315</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52985-901-09</NDCCode>
    <PackageDescription>12 BOTTLE in 1 BOX (52985-901-09)  &gt; 1000 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>52985-0901-09</NDC11Code>
    <ProductNDC>52985-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200618</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Anhui Oasis Disinfection Products Co., Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the hands To help decrease bacteria on the skin when water, soap and towel are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52985-901-12</NDCCode>
    <PackageDescription>500 BOTTLE in 1 BOX (52985-901-12)  &gt; 15 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>52985-0901-12</NDC11Code>
    <ProductNDC>52985-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200618</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Anhui Oasis Disinfection Products Co., Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce bacteria on the hands To help decrease bacteria on the skin when water, soap and towel are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61444-901-12</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE, GLASS (61444-901-12) </PackageDescription>
    <NDC11Code>61444-0901-12</NDC11Code>
    <ProductNDC>61444-901</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Urea C-13</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>19960208</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Cambridge Isotope Laboratories, Inc.</LabelerName>
    <SubstanceName>UREA C-13</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-06-14</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>08-FEB-96</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>63029-901-01</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 BOX (63029-901-01)  / 12 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63029-0901-01</NDC11Code>
    <ProductNDC>63029-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dramamine Original Formula</ProprietaryName>
    <NonProprietaryName>Dimenhydrinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M009</ApplicationNumber>
    <LabelerName>Medtech Products Inc.</LabelerName>
    <SubstanceName>DIMENHYDRINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63029-901-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (63029-901-02)  / 12 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>63029-0901-02</NDC11Code>
    <ProductNDC>63029-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dramamine Original Formula</ProprietaryName>
    <NonProprietaryName>Dimenhydrinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M009</ApplicationNumber>
    <LabelerName>Medtech Products Inc.</LabelerName>
    <SubstanceName>DIMENHYDRINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for prevention and treatment of these symptoms associated with motion sickness: 1 nausea, 2 vomiting, 3 dizziness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68428-901-12</NDCCode>
    <PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-901-12)</PackageDescription>
    <NDC11Code>68428-0901-12</NDC11Code>
    <ProductNDC>68428-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cadmium Bromatum</ProprietaryName>
    <NonProprietaryName>Cadmium Bromide</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100615</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>CADMIUM BROMIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-22</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69693-901-04</NDCCode>
    <PackageDescription>12.4 mL in 1 BOTTLE, DROPPER (69693-901-04) </PackageDescription>
    <NDC11Code>69693-0901-04</NDC11Code>
    <ProductNDC>69693-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine</ProprietaryName>
    <NonProprietaryName>Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20250217</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Clarion Brands LLC</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of pain.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69898-901-12</NDCCode>
    <PackageDescription>354 mL in 1 BOTTLE, PLASTIC (69898-901-12) </PackageDescription>
    <NDC11Code>69898-0901-12</NDC11Code>
    <ProductNDC>69898-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Premium Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200805</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>MD Science Lab LLC</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75111-901-04</NDCCode>
    <PackageDescription>12 TABLET in 1 BAG (75111-901-04) </PackageDescription>
    <NDC11Code>75111-0901-04</NDC11Code>
    <ProductNDC>75111-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Effervescent Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Enping Jiaxin Daily Necessities Co., Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>1/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Disposable Effervescent Tablets Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75111-901-12</NDCCode>
    <PackageDescription>10 TABLET in 1 BOX (75111-901-12) </PackageDescription>
    <NDC11Code>75111-0901-12</NDC11Code>
    <ProductNDC>75111-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Effervescent Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Enping Jiaxin Daily Necessities Co., Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>1/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Disposable Effervescent Tablets Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75111-901-13</NDCCode>
    <PackageDescription>12 TABLET in 1 BOX (75111-901-13) </PackageDescription>
    <NDC11Code>75111-0901-13</NDC11Code>
    <ProductNDC>75111-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Effervescent Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Enping Jiaxin Daily Necessities Co., Ltd.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>1/1001</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Disposable Effervescent Tablets Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>77095-901-12</NDCCode>
    <PackageDescription>13680 mL in 1 BOTTLE, PUMP (77095-901-12) </PackageDescription>
    <NDC11Code>77095-0901-12</NDC11Code>
    <ProductNDC>77095-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natezone Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200706</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>U.S. FEDERAL PHARMACEUTICAL FIRM, INC.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>90010-901-12</NDCCode>
    <PackageDescription>13680 mL in 1 BOTTLE, PUMP (90010-901-12) </PackageDescription>
    <NDC11Code>90010-0901-12</NDC11Code>
    <ProductNDC>90010-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Natezone Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200807</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Guangzhou Cluster Mapping Supply Chain Co., Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200807</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69918-101-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69918-101-01)  / 100 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>69918-0101-01</NDC11Code>
    <ProductNDC>69918-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151210</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019955</ApplicationNumber>
    <LabelerName>Nordic Pharma, Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Central Diabetes Insipidus: Desmopressin Acetate Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.</IndicationAndUsage>
    <Description>Desmopressin Acetate Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:. Mol. Wt. 1183.34 Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Acetate Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>69918-201-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69918-201-01)  / 100 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>69918-0201-01</NDC11Code>
    <ProductNDC>69918-201</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desmopressin Acetate</ProprietaryName>
    <NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151210</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019955</ApplicationNumber>
    <LabelerName>Nordic Pharma, Inc.</LabelerName>
    <SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Central Diabetes Insipidus: Desmopressin Acetate Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.</IndicationAndUsage>
    <Description>Desmopressin Acetate Tablets (desmopressin acetate) are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:. Mol. Wt. 1183.34 Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Acetate Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>69918-560-30</NDCCode>
    <PackageDescription>30 SUPPOSITORY in 1 BOX (69918-560-30) </PackageDescription>
    <NDC11Code>69918-0560-30</NDC11Code>
    <ProductNDC>69918-560</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mesalamine Rectal</ProprietaryName>
    <NonProprietaryName>Mesalamine</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20190624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208362</ApplicationNumber>
    <LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MESALAMINE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mesalamine Rectal Suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.</IndicationAndUsage>
    <Description>The active ingredient in Mesalamine Rectal Suppository 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5- aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each Mesalamine Rectal Suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF. The empirical formula is C7H7NO3, representing a molecular weight of 153.14. The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>10345-901-15</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (10345-901-15)  / 15 mL in 1 TUBE</PackageDescription>
    <NDC11Code>10345-0901-15</NDC11Code>
    <ProductNDC>10345-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Erborian - Bb Creme Au Ginseng Dore Spf 20</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150206</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>LABORATOIRES M&amp;L</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>30; 62.8; 19.2</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10345-901-45</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (10345-901-45)  / 45 mL in 1 TUBE</PackageDescription>
    <NDC11Code>10345-0901-45</NDC11Code>
    <ProductNDC>10345-901</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Erborian - Bb Creme Au Ginseng Dore Spf 20</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150206</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>LABORATOIRES M&amp;L</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>30; 62.8; 19.2</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10544-901-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (10544-901-60)</PackageDescription>
    <NDC11Code>10544-0901-60</NDC11Code>
    <ProductNDC>10544-901</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077064</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg or 850 mg or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and sodium starch glycolate. Metformin hydrochloride extended-release tablets contain 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets 500 mg and 750 mg contain the inactive ingredients glyceryl behenate, hypromellose, microcrystalline cellulose and povidone.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>69918-901-12</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>69918-700-12</NDCCode><ProprietaryName>Succinylcholine Chloride</ProprietaryName><NonProprietaryName>Succinylcholine Chloride</NonProprietaryName></NDC><NDC><NDCCode>69918-901-10</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>69918-901-11</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>10122-901-12</NDCCode><ProprietaryName>Zyflo</ProprietaryName><NonProprietaryName>Zileuton</NonProprietaryName></NDC><NDC><NDCCode>15127-901-24</NDCCode><ProprietaryName>Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate</NonProprietaryName></NDC><NDC><NDCCode>37808-901-12</NDCCode><ProprietaryName>Milk Of Magnesia</ProprietaryName><NonProprietaryName>Magnesium Hydroxide</NonProprietaryName></NDC><NDC><NDCCode>43538-901-12</NDCCode><ProprietaryName>Synalar</ProprietaryName><NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>49035-901-08</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>49035-901-12</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>49035-901-42</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>52985-901-09</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>52985-901-12</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>61444-901-12</NDCCode><NonProprietaryName>Urea C-13</NonProprietaryName></NDC><NDC><NDCCode>63029-901-01</NDCCode><ProprietaryName>Dramamine Original Formula</ProprietaryName><NonProprietaryName>Dimenhydrinate</NonProprietaryName></NDC><NDC><NDCCode>63029-901-02</NDCCode><ProprietaryName>Dramamine Original Formula</ProprietaryName><NonProprietaryName>Dimenhydrinate</NonProprietaryName></NDC><NDC><NDCCode>68428-901-12</NDCCode><ProprietaryName>Cadmium Bromatum</ProprietaryName><NonProprietaryName>Cadmium Bromide</NonProprietaryName></NDC><NDC><NDCCode>69693-901-04</NDCCode><ProprietaryName>Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine</ProprietaryName><NonProprietaryName>Lipo Flavonoid Ear Pain Relief Drops With 4% Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>69898-901-12</NDCCode><ProprietaryName>Premium Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>75111-901-04</NDCCode><ProprietaryName>Effervescent Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>75111-901-12</NDCCode><ProprietaryName>Effervescent Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>75111-901-13</NDCCode><ProprietaryName>Effervescent Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>77095-901-12</NDCCode><ProprietaryName>Natezone Hand Sanitizer</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>90010-901-12</NDCCode><ProprietaryName>Natezone Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>69918-101-01</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>69918-201-01</NDCCode><ProprietaryName>Desmopressin Acetate</ProprietaryName><NonProprietaryName>Desmopressin Acetate</NonProprietaryName></NDC><NDC><NDCCode>69918-560-30</NDCCode><ProprietaryName>Mesalamine Rectal</ProprietaryName><NonProprietaryName>Mesalamine</NonProprietaryName></NDC><NDC><NDCCode>10345-901-15</NDCCode><ProprietaryName>Erborian - Bb Creme Au Ginseng Dore Spf 20</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10345-901-45</NDCCode><ProprietaryName>Erborian - Bb Creme Au Ginseng Dore Spf 20</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10544-901-60</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin 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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) based on the free-form lookup query.
    • search_and_keywords - returns not only free-form lookup results but also keywords relevant to the original query.
    • getcode - this method allows retrieval of full infrormation regarding one item based on the provided key.
    • getcodes - this method allows retrieval of full infrormation regarding number of items based on the provided keys.
  • NPI-specific operations:
    • validate — allows to determine whether provider's information is valid based on data in the CMS database.
    • paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
    • search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
    • zipradius — allows to get npis by zipcode & radius.
    • npideactivated — allows to get deactivated npis between two dates.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
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    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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

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

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

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

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

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

            Console.WriteLine(response);

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

Output

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