RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "48083-310-31",
      "PackageDescription": "50 POUCH in 1 BOX (48083-310-31)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0310-31",
      "ProductNDC": "48083-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-cet Plus",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever."
    },
    {
      "NDCCode": "48083-305-31",
      "PackageDescription": "50 POUCH in 1 BOX (48083-305-31)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0305-31",
      "ProductNDC": "48083-305",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-antacid",
      "NonProprietaryName": "Calcium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "CALCIUM CARBONATE",
      "StrengthNumber": "420",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves: heartburn. acid indigestion. sour stomach. relieves: upset stomach associated with these symptoms."
    },
    {
      "NDCCode": "48083-330-31",
      "PackageDescription": "50 POUCH in 1 BOX (48083-330-31)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0330-31",
      "ProductNDC": "48083-330",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-sine",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of nasal congestion due to a cold, hay fever or other upper respiratory allergies associated with sinusitis. Temporarily relieves stuffy nose, sinus congestion and pressure."
    },
    {
      "NDCCode": "31722-310-32",
      "PackageDescription": "25 VIAL, GLASS in 1 BOX (31722-310-32)  / 4 mL in 1 VIAL, GLASS (31722-310-31) ",
      "NDC11Code": "31722-0310-32",
      "ProductNDC": "31722-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20241213",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217557",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema:Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.",
      "Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 5-(aminosulfonyl)-4-chloro-2-[(2-furanylmethyl)amino] Benzoic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, freely soluble in acetone, in dimethyl formamide and in solutions of alkali hydroxides. Soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform. The structural formula is as follows:. C 12H 11C1N 2O 5S                                 M.W. 330.74 Each mL contains: Furosemide 10 mg, Sodium Chloride for isotonicity, Sodium Hydroxide, Water for Injection q.s., and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
    },
    {
      "NDCCode": "66129-310-31",
      "PackageDescription": "50 g in 1 TUBE (66129-310-31)",
      "NDC11Code": "66129-0310-31",
      "ProductNDC": "66129-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crusader Skin Lightening",
      "NonProprietaryName": "Hydroquinone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part358A",
      "LabelerName": "International Beauty Exchange",
      "SubstanceName": "HYDROQUINONE; LANOLIN; PADIMATE O",
      "StrengthNumber": "1; .5; .25",
      "StrengthUnit": "g/50g; g/50g; g/50g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the gradual fading of dark areas in the skin such as freckles, age and liver spots."
    },
    {
      "NDCCode": "48083-310-27",
      "PackageDescription": "25 POUCH in 1 BOX (48083-310-27)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0310-27",
      "ProductNDC": "48083-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-cet Plus",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever."
    },
    {
      "NDCCode": "48083-310-30",
      "PackageDescription": "50 POUCH in 1 BOX (48083-310-30)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0310-30",
      "ProductNDC": "48083-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-cet Plus",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever."
    },
    {
      "NDCCode": "48083-310-33",
      "PackageDescription": "125 POUCH in 1 BOX (48083-310-33)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0310-33",
      "ProductNDC": "48083-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-cet Plus",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever."
    },
    {
      "NDCCode": "48083-310-36",
      "PackageDescription": "250 POUCH in 1 BOX (48083-310-36)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0310-36",
      "ProductNDC": "48083-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-cet Plus",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever."
    },
    {
      "NDCCode": "48083-310-39",
      "PackageDescription": "500 POUCH in 1 BOX (48083-310-39)  > 2 TABLET in 1 POUCH",
      "NDC11Code": "48083-0310-39",
      "ProductNDC": "48083-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Certi-cet Plus",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Certified Safety Manufacturing",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20171229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever."
    },
    {
      "NDCCode": "0264-1800-31",
      "PackageDescription": "84 CONTAINER in 1 CASE (0264-1800-31)  > 50 mL in 1 CONTAINER",
      "NDC11Code": "00264-1800-31",
      "ProductNDC": "0264-1800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19780208",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017464",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19780208",
      "SamplePackage": "N",
      "IndicationAndUsage": "This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.",
      "Description": "Each mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mg; Water for Injection USP qspH adjusted with Hydrochloric Acid NFpH: 5.5 (4.5–7.0)Calculated Osmolarity: 310 mOsmol/literConcentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4. This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use  of the container to properly identify the ports. No vapor barrier is necessary."
    },
    {
      "NDCCode": "0338-0143-03",
      "PackageDescription": "500 mL in 1 BAG (0338-0143-03) ",
      "NDC11Code": "00338-0143-03",
      "ProductNDC": "0338-0143",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose And Electrolyte No. 48",
      "NonProprietaryName": "Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19790202",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017484",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE",
      "StrengthNumber": "5; 260; 141; 31; 20; 12",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19790202",
      "SamplePackage": "N",
      "IndicationAndUsage": "5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.",
      "Description": "5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 260 mg Sodium Lactate (C3H5NaO3), 141 mg Potassium Chloride, USP (KCl), 31 mg Magnesium Chloride, USP (MgCl26H20), 20 mg Monobasic Potassium Phosphate, NF (KH2PO4), and 12 mg Sodium Chloride, USP (NaCl). It contains no antimicrobial agents. The pH is 5.0 (4.0 to 6.5). 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 25 mEq sodium, 20 mEq potassium, 3 mEq magnesium, 24 mEq chloride, 23 mEq lactate and 3 mEq phosphate (as HPO42-). The osmolarity is 348 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 180 kcal/L. Dextrose is derived from corn. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-0811-04",
      "PackageDescription": "1000 mL in 1 BAG (0338-0811-04) ",
      "NDC11Code": "00338-0811-04",
      "ProductNDC": "0338-0811",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Lactated Ringers And Dextrose",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19850405",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019367",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
      "StrengthNumber": "5; 600; 310; 179; 20",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19850405",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients.",
      "Description": "Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn. The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. The VIAFLEX plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). Small amounts of its chemical components (e.g., di-2-ethylhexyl phthalate [DEHP]) may leach out within the expiration period. Animal tests, USP biological tests for plastic containers, and tissue culture toxicity studies have demonstrated that the container meets safety requirements. The container is overwrapped to provide protection from the physical environment and an additional moisture barrier."
    },
    {
      "NDCCode": "10357-310-01",
      "PackageDescription": "50 kg in 1 DRUM (10357-310-01) ",
      "NDC11Code": "10357-0310-01",
      "ProductNDC": "10357-310",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Aspirin",
      "DosageFormName": "GRANULE",
      "StartMarketingDate": "20181001",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Novacyl SAS",
      "SubstanceName": "ASPIRIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-08-31",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "01-OCT-18"
    },
    {
      "NDCCode": "12854-310-01",
      "PackageDescription": "21 CARTON in 1 BOX (12854-310-01)  / 3 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE",
      "NDC11Code": "12854-0310-01",
      "ProductNDC": "12854-310",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Fitusiran",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20250328",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Sanofi-Aventis Deutschland GmbH",
      "SubstanceName": "FITUSIRAN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/.5mL",
      "Status": "Unfinished",
      "LastUpdate": "2025-03-31",
      "StartMarketingDatePackage": "28-MAR-25"
    },
    {
      "NDCCode": "14335-310-02",
      "PackageDescription": "25 kg in 1 DRUM (14335-310-02) ",
      "NDC11Code": "14335-0310-02",
      "ProductNDC": "14335-310",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gadoterate Meglumine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220531",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "GADOTERATE MEGLUMINE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/25kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "31-MAY-22"
    },
    {
      "NDCCode": "24338-310-10",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10)  / 10 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "24338-0310-10",
      "ProductNDC": "24338-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ferabright",
      "NonProprietaryName": "Ferumoxytol",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20251020",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA219868",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "SubstanceName": "FERUMOXYTOL",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251020",
      "SamplePackage": "N",
      "IndicationAndUsage": "FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.",
      "Description": "FERABRIGHT (ferumoxytol injection) is an iron-based contrast agent for intravenous use.  Ferumoxytol is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size ranges from 31 nm to 43 nm in diameter. The chemical formula of ferumoxytol is Fe5874O8752-C11719H18682O9933Na414 with an apparent molecular weight of 750 kDa. Each mL contains 30 mg of elemental iron and 30 mg of polyglucose sorbitol carboxymethylether as ferumoxytol, and 44 mg of mannitol. It contains no preservatives.   FERABRIGHT is a sterile, aqueous, black to reddish brown, isotonic colloidal solution with an osmolality of 270 mOsm/kg to 330 mOsm/kg, magnetic susceptibility of 27,250 to 39,000 x 10-6 cgs/g Fe, and a pH of 6 to 8."
    },
    {
      "NDCCode": "33342-310-07",
      "PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07) ",
      "NDC11Code": "33342-0310-07",
      "ProductNDC": "33342-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lansoprazole",
      "NonProprietaryName": "Lansoprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208671",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "LANSOPRAZOLE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lansoprazole delayed-release capsules, are a proton pump inhibitors (PPIs) indicated for the:  Treatment of active duodenal ulcer in adults. (1.1)   Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2)   Maintenance of healed duodenal ulcers in adults. (1.3)   Treatment of active benign gastric ulcer in adults. (1.4)   Healing of nonsteroidal anti-inflammatory drugs (NSAID)- associated gastric ulcer in adults. (1.5)   Risk reduction of NSAID-associated gastric ulcer in adults. (1.6)   Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7)  Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8)   Maintenance of healing of EE in adults. (1.9)   Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
      "Description": "The active ingredient in Lansoprazole Delayed-Release Capsules is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, maize starch, ethylcellulose, hydroxypropyl methylcellulose, magnesium carbonate, low-substituted hydroxypropyl cellulose, talc, polyethylene glycol, methacrylic acid copolymer, titanium dioxide, polysorbate 80, colloidal silicon dioxide, FD & C blue 1, D & C red 28, FD & C red 40, gelatin, FD & C green 31. 1 Lansoprazole 15-mg capsules only. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "48581-310-55",
      "PackageDescription": "23 kg in 1 DRUM (48581-310-55) ",
      "NDC11Code": "48581-0310-55",
      "ProductNDC": "48581-310",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Crotamiton",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20180731",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Egis Pharmaceuticals PLC",
      "SubstanceName": "CROTAMITON",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-19",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "31-JUL-18"
    },
    {
      "NDCCode": "51655-310-53",
      "PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (51655-310-53) ",
      "NDC11Code": "51655-0310-53",
      "ProductNDC": "51655-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076796",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221128",
      "SamplePackage": "N",
      "Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1."
    },
    {
      "NDCCode": "55111-360-06",
      "PackageDescription": "6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-360-06) ",
      "NDC11Code": "55111-0360-06",
      "ProductNDC": "55111-360",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desloratadine",
      "NonProprietaryName": "Desloratadine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078367",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "DESLORATADINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130111",
      "SamplePackage": "N",
      "Description": "The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure."
    },
    {
      "NDCCode": "55111-360-31",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (55111-360-31)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "55111-0360-31",
      "ProductNDC": "55111-360",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desloratadine",
      "NonProprietaryName": "Desloratadine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078367",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "DESLORATADINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130111",
      "SamplePackage": "N",
      "Description": "The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure."
    },
    {
      "NDCCode": "55111-551-06",
      "PackageDescription": "6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-551-06) ",
      "NDC11Code": "55111-0551-06",
      "ProductNDC": "55111-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desloratadine",
      "NonProprietaryName": "Desloratadine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078367",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "DESLORATADINE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130111",
      "SamplePackage": "N",
      "Description": "The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure."
    },
    {
      "NDCCode": "55111-551-31",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (55111-551-31)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "55111-0551-31",
      "ProductNDC": "55111-551",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desloratadine",
      "NonProprietaryName": "Desloratadine",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078367",
      "LabelerName": "Dr. Reddy's Laboratories Limited",
      "SubstanceName": "DESLORATADINE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130111",
      "SamplePackage": "N",
      "Description": "The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure."
    },
    {
      "NDCCode": "56062-310-34",
      "PackageDescription": "1 BOTTLE in 1 CARTON (56062-310-34)  > 237 mL in 1 BOTTLE",
      "NDC11Code": "56062-0310-34",
      "ProductNDC": "56062-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tussin",
      "ProprietaryNameSuffix": "Expectorant For Adults",
      "NonProprietaryName": "Guaifenesin",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040213",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Publix Super Markets Inc",
      "SubstanceName": "GUAIFENESIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20040213",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive."
    },
    {
      "NDCCode": "59088-798-00",
      "PackageDescription": "1 KIT in 1 KIT (59088-798-00)  *  1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2)  / 150 mL in 1 BOTTLE, DROPPER *  237 mL in 1 BOTTLE, PUMP (59088-310-16) ",
      "NDC11Code": "59088-0798-00",
      "ProductNDC": "59088-798",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lextol",
      "NonProprietaryName": "Diclofenac Sodium, Capsaicin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230825",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230825",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61786-217-31",
      "PackageDescription": "500 mL in 1 CONTAINER (61786-217-31)",
      "NDC11Code": "61786-0217-31",
      "ProductNDC": "61786-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "20150311",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016733",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": ".9",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.",
      "Description": "Each 100 mL contains:Sodium Chloride USP 0.9 g; Water for Injection USP qs. pH adjusted with Hydrochloric Acid NFpH: 5.0 (4.5–7.0)      Calculated Osmolarity: 310 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154. 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC Container is PVC-free and DEHP-free."
    },
    {
      "NDCCode": "64406-310-01",
      "PackageDescription": "504 VIAL, SINGLE-USE in 1 BOX (64406-310-01)  / 5 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "64406-0310-01",
      "ProductNDC": "64406-310",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Nusinersen",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20250518",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Biogen",
      "SubstanceName": "NUSINERSEN",
      "StrengthNumber": "5.6",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2025-05-31",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "18-MAY-25"
    },
    {
      "NDCCode": "72580-310-11",
      "PackageDescription": "120 mL in 1 BOTTLE (72580-310-11) ",
      "NDC11Code": "72580-0310-11",
      "ProductNDC": "72580-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "All Purpose Hand Sanitizing",
      "ProprietaryNameSuffix": "70 Percent",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200825",
      "EndMarketingDate": "20230731",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Formology Lab Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200825",
      "EndMarketingDatePackage": "20230731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85766-193-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (85766-193-05)  / 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "85766-0193-05",
      "ProductNDC": "85766-193",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loteprednol Etabonate",
      "NonProprietaryName": "Loteprednol Etabonate",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20231024",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215933",
      "LabelerName": "Sportpharm LLC",
      "SubstanceName": "LOTEPREDNOL ETABONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260326",
      "SamplePackage": "N",
      "IndicationAndUsage": "Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.",
      "Description": "Loteprednol Etabonate Ophthalmic Suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Water for Injection and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"48083-310-31","ProprietaryName":"Certi-cet Plus","NonProprietaryName":"Acetaminophen"},{"NDCCode":"48083-305-31","ProprietaryName":"Certi-antacid","NonProprietaryName":"Calcium Carbonate"},{"NDCCode":"48083-330-31","ProprietaryName":"Certi-sine","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"31722-310-32","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"66129-310-31","ProprietaryName":"Crusader Skin Lightening","NonProprietaryName":"Hydroquinone"},{"NDCCode":"48083-310-27","ProprietaryName":"Certi-cet Plus","NonProprietaryName":"Acetaminophen"},{"NDCCode":"48083-310-30","ProprietaryName":"Certi-cet Plus","NonProprietaryName":"Acetaminophen"},{"NDCCode":"48083-310-33","ProprietaryName":"Certi-cet Plus","NonProprietaryName":"Acetaminophen"},{"NDCCode":"48083-310-36","ProprietaryName":"Certi-cet Plus","NonProprietaryName":"Acetaminophen"},{"NDCCode":"48083-310-39","ProprietaryName":"Certi-cet Plus","NonProprietaryName":"Acetaminophen"},{"NDCCode":"0264-1800-31","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"0338-0143-03","ProprietaryName":"Dextrose And Electrolyte No. 48","NonProprietaryName":"Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate"},{"NDCCode":"0338-0811-04","ProprietaryName":"Potassium Chloride In Lactated Ringers And Dextrose","NonProprietaryName":"Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride"},{"NDCCode":"10357-310-01","NonProprietaryName":"Aspirin"},{"NDCCode":"12854-310-01","NonProprietaryName":"Fitusiran"},{"NDCCode":"14335-310-02","NonProprietaryName":"Gadoterate Meglumine"},{"NDCCode":"24338-310-10","ProprietaryName":"Ferabright","NonProprietaryName":"Ferumoxytol"},{"NDCCode":"33342-310-07","ProprietaryName":"Lansoprazole","NonProprietaryName":"Lansoprazole"},{"NDCCode":"48581-310-55","NonProprietaryName":"Crotamiton"},{"NDCCode":"51655-310-53","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"55111-360-06","ProprietaryName":"Desloratadine","NonProprietaryName":"Desloratadine"},{"NDCCode":"55111-360-31","ProprietaryName":"Desloratadine","NonProprietaryName":"Desloratadine"},{"NDCCode":"55111-551-06","ProprietaryName":"Desloratadine","NonProprietaryName":"Desloratadine"},{"NDCCode":"55111-551-31","ProprietaryName":"Desloratadine","NonProprietaryName":"Desloratadine"},{"NDCCode":"56062-310-34","ProprietaryName":"Tussin","NonProprietaryName":"Guaifenesin"},{"NDCCode":"59088-798-00","ProprietaryName":"Lextol","NonProprietaryName":"Diclofenac Sodium, Capsaicin"},{"NDCCode":"61786-217-31","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"64406-310-01","NonProprietaryName":"Nusinersen"},{"NDCCode":"72580-310-11","ProprietaryName":"All Purpose Hand Sanitizing","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"85766-193-05","ProprietaryName":"Loteprednol Etabonate","NonProprietaryName":"Loteprednol Etabonate"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>48083-310-31</NDCCode>
    <PackageDescription>50 POUCH in 1 BOX (48083-310-31)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0310-31</NDC11Code>
    <ProductNDC>48083-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-cet Plus</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48083-305-31</NDCCode>
    <PackageDescription>50 POUCH in 1 BOX (48083-305-31)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0305-31</NDC11Code>
    <ProductNDC>48083-305</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-antacid</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>CALCIUM CARBONATE</SubstanceName>
    <StrengthNumber>420</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves: heartburn. acid indigestion. sour stomach. relieves: upset stomach associated with these symptoms.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48083-330-31</NDCCode>
    <PackageDescription>50 POUCH in 1 BOX (48083-330-31)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0330-31</NDC11Code>
    <ProductNDC>48083-330</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-sine</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of nasal congestion due to a cold, hay fever or other upper respiratory allergies associated with sinusitis. Temporarily relieves stuffy nose, sinus congestion and pressure.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-310-32</NDCCode>
    <PackageDescription>25 VIAL, GLASS in 1 BOX (31722-310-32)  / 4 mL in 1 VIAL, GLASS (31722-310-31) </PackageDescription>
    <NDC11Code>31722-0310-32</NDC11Code>
    <ProductNDC>31722-310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20241213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217557</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema:Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.</IndicationAndUsage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 5-(aminosulfonyl)-4-chloro-2-[(2-furanylmethyl)amino] Benzoic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, freely soluble in acetone, in dimethyl formamide and in solutions of alkali hydroxides. Soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform. The structural formula is as follows:. C 12H 11C1N 2O 5S                                 M.W. 330.74 Each mL contains: Furosemide 10 mg, Sodium Chloride for isotonicity, Sodium Hydroxide, Water for Injection q.s., and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>66129-310-31</NDCCode>
    <PackageDescription>50 g in 1 TUBE (66129-310-31)</PackageDescription>
    <NDC11Code>66129-0310-31</NDC11Code>
    <ProductNDC>66129-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crusader Skin Lightening</ProprietaryName>
    <NonProprietaryName>Hydroquinone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part358A</ApplicationNumber>
    <LabelerName>International Beauty Exchange</LabelerName>
    <SubstanceName>HYDROQUINONE; LANOLIN; PADIMATE O</SubstanceName>
    <StrengthNumber>1; .5; .25</StrengthNumber>
    <StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the gradual fading of dark areas in the skin such as freckles, age and liver spots.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48083-310-27</NDCCode>
    <PackageDescription>25 POUCH in 1 BOX (48083-310-27)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0310-27</NDC11Code>
    <ProductNDC>48083-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-cet Plus</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48083-310-30</NDCCode>
    <PackageDescription>50 POUCH in 1 BOX (48083-310-30)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0310-30</NDC11Code>
    <ProductNDC>48083-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-cet Plus</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48083-310-33</NDCCode>
    <PackageDescription>125 POUCH in 1 BOX (48083-310-33)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0310-33</NDC11Code>
    <ProductNDC>48083-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-cet Plus</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48083-310-36</NDCCode>
    <PackageDescription>250 POUCH in 1 BOX (48083-310-36)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0310-36</NDC11Code>
    <ProductNDC>48083-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-cet Plus</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48083-310-39</NDCCode>
    <PackageDescription>500 POUCH in 1 BOX (48083-310-39)  &gt; 2 TABLET in 1 POUCH</PackageDescription>
    <NDC11Code>48083-0310-39</NDC11Code>
    <ProductNDC>48083-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Certi-cet Plus</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Certified Safety Manufacturing</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporary relief of minor aches and pains associated with:common coldsheadachetoothachemuscular achesbackachearthritismenstrual cramps. and reduction of fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0264-1800-31</NDCCode>
    <PackageDescription>84 CONTAINER in 1 CASE (0264-1800-31)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-1800-31</NDC11Code>
    <ProductNDC>0264-1800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19780208</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017464</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19780208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.</IndicationAndUsage>
    <Description>Each mL of 0.9% Sodium Chloride Injection USP contains. Sodium Chloride USP 9 mg; Water for Injection USP qspH adjusted with Hydrochloric Acid NFpH: 5.5 (4.5–7.0)Calculated Osmolarity: 310 mOsmol/literConcentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4. This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. Not made with natural rubber latex, PVC or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use  of the container to properly identify the ports. No vapor barrier is necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0143-03</NDCCode>
    <PackageDescription>500 mL in 1 BAG (0338-0143-03) </PackageDescription>
    <NDC11Code>00338-0143-03</NDC11Code>
    <ProductNDC>0338-0143</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextrose And Electrolyte No. 48</ProprietaryName>
    <NonProprietaryName>Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19790202</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017484</ApplicationNumber>
    <LabelerName>Baxter Healthcare Company</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>5; 260; 141; 31; 20; 12</StrengthNumber>
    <StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19790202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.</IndicationAndUsage>
    <Description>5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 260 mg Sodium Lactate (C3H5NaO3), 141 mg Potassium Chloride, USP (KCl), 31 mg Magnesium Chloride, USP (MgCl26H20), 20 mg Monobasic Potassium Phosphate, NF (KH2PO4), and 12 mg Sodium Chloride, USP (NaCl). It contains no antimicrobial agents. The pH is 5.0 (4.0 to 6.5). 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 25 mEq sodium, 20 mEq potassium, 3 mEq magnesium, 24 mEq chloride, 23 mEq lactate and 3 mEq phosphate (as HPO42-). The osmolarity is 348 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 180 kcal/L. Dextrose is derived from corn. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0811-04</NDCCode>
    <PackageDescription>1000 mL in 1 BAG (0338-0811-04) </PackageDescription>
    <NDC11Code>00338-0811-04</NDC11Code>
    <ProductNDC>0338-0811</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride In Lactated Ringers And Dextrose</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19850405</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019367</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
    <StrengthNumber>5; 600; 310; 179; 20</StrengthNumber>
    <StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients.</IndicationAndUsage>
    <Description>Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn. The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. The VIAFLEX plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). Small amounts of its chemical components (e.g., di-2-ethylhexyl phthalate [DEHP]) may leach out within the expiration period. Animal tests, USP biological tests for plastic containers, and tissue culture toxicity studies have demonstrated that the container meets safety requirements. The container is overwrapped to provide protection from the physical environment and an additional moisture barrier.</Description>
  </NDC>
  <NDC>
    <NDCCode>10357-310-01</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (10357-310-01) </PackageDescription>
    <NDC11Code>10357-0310-01</NDC11Code>
    <ProductNDC>10357-310</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Aspirin</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <StartMarketingDate>20181001</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Novacyl SAS</LabelerName>
    <SubstanceName>ASPIRIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-08-31</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-OCT-18</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>12854-310-01</NDCCode>
    <PackageDescription>21 CARTON in 1 BOX (12854-310-01)  / 3 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>12854-0310-01</NDC11Code>
    <ProductNDC>12854-310</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Fitusiran</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20250328</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Sanofi-Aventis Deutschland GmbH</LabelerName>
    <SubstanceName>FITUSIRAN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-03-31</LastUpdate>
    <StartMarketingDatePackage>28-MAR-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14335-310-02</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (14335-310-02) </PackageDescription>
    <NDC11Code>14335-0310-02</NDC11Code>
    <ProductNDC>14335-310</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220531</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/25kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-MAY-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>24338-310-10</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10)  / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>24338-0310-10</NDC11Code>
    <ProductNDC>24338-310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ferabright</ProprietaryName>
    <NonProprietaryName>Ferumoxytol</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251020</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219868</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FERUMOXYTOL</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.</IndicationAndUsage>
    <Description>FERABRIGHT (ferumoxytol injection) is an iron-based contrast agent for intravenous use.  Ferumoxytol is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size ranges from 31 nm to 43 nm in diameter. The chemical formula of ferumoxytol is Fe5874O8752-C11719H18682O9933Na414 with an apparent molecular weight of 750 kDa. Each mL contains 30 mg of elemental iron and 30 mg of polyglucose sorbitol carboxymethylether as ferumoxytol, and 44 mg of mannitol. It contains no preservatives.   FERABRIGHT is a sterile, aqueous, black to reddish brown, isotonic colloidal solution with an osmolality of 270 mOsm/kg to 330 mOsm/kg, magnetic susceptibility of 27,250 to 39,000 x 10-6 cgs/g Fe, and a pH of 6 to 8.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-310-07</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07) </PackageDescription>
    <NDC11Code>33342-0310-07</NDC11Code>
    <ProductNDC>33342-310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lansoprazole</ProprietaryName>
    <NonProprietaryName>Lansoprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208671</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LANSOPRAZOLE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lansoprazole delayed-release capsules, are a proton pump inhibitors (PPIs) indicated for the:  Treatment of active duodenal ulcer in adults. (1.1)   Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2)   Maintenance of healed duodenal ulcers in adults. (1.3)   Treatment of active benign gastric ulcer in adults. (1.4)   Healing of nonsteroidal anti-inflammatory drugs (NSAID)- associated gastric ulcer in adults. (1.5)   Risk reduction of NSAID-associated gastric ulcer in adults. (1.6)   Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7)  Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8)   Maintenance of healing of EE in adults. (1.9)   Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
    <Description>The active ingredient in Lansoprazole Delayed-Release Capsules is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, maize starch, ethylcellulose, hydroxypropyl methylcellulose, magnesium carbonate, low-substituted hydroxypropyl cellulose, talc, polyethylene glycol, methacrylic acid copolymer, titanium dioxide, polysorbate 80, colloidal silicon dioxide, FD &amp; C blue 1, D &amp; C red 28, FD &amp; C red 40, gelatin, FD &amp; C green 31. 1 Lansoprazole 15-mg capsules only. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>48581-310-55</NDCCode>
    <PackageDescription>23 kg in 1 DRUM (48581-310-55) </PackageDescription>
    <NDC11Code>48581-0310-55</NDC11Code>
    <ProductNDC>48581-310</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Crotamiton</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20180731</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Egis Pharmaceuticals PLC</LabelerName>
    <SubstanceName>CROTAMITON</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>31-JUL-18</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51655-310-53</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (51655-310-53) </PackageDescription>
    <NDC11Code>51655-0310-53</NDC11Code>
    <ProductNDC>51655-310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076796</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-360-06</NDCCode>
    <PackageDescription>6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-360-06) </PackageDescription>
    <NDC11Code>55111-0360-06</NDC11Code>
    <ProductNDC>55111-360</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desloratadine</ProprietaryName>
    <NonProprietaryName>Desloratadine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078367</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>DESLORATADINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-360-31</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (55111-360-31)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55111-0360-31</NDC11Code>
    <ProductNDC>55111-360</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desloratadine</ProprietaryName>
    <NonProprietaryName>Desloratadine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078367</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>DESLORATADINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-551-06</NDCCode>
    <PackageDescription>6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-551-06) </PackageDescription>
    <NDC11Code>55111-0551-06</NDC11Code>
    <ProductNDC>55111-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desloratadine</ProprietaryName>
    <NonProprietaryName>Desloratadine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078367</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>DESLORATADINE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-551-31</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (55111-551-31)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55111-0551-31</NDC11Code>
    <ProductNDC>55111-551</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desloratadine</ProprietaryName>
    <NonProprietaryName>Desloratadine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078367</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>DESLORATADINE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>The desloratadine orally disintegrating tablets, USP light red colored, speckled, round, flat, uncoated, beveled edged debossed with “R” on one side and “551” on the other side for the 2.5 mg tablets and a “light red colored, speckled, round, flat, uncoated, beveled edged debossed with “RDY” on one side and “360” on the other side  for the 5 mg tablets. Each orally disintegrating tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, mannitol, lactose anhydrous, microcrystalline cellulose, polacrilex resin, sodium stearyl fumarate, talc, tutti frutti flavor. Desloratadine, USP is a white to light pink colored powder that is soluble in dichloromethane. It has an molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>56062-310-34</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (56062-310-34)  &gt; 237 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>56062-0310-34</NDC11Code>
    <ProductNDC>56062-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tussin</ProprietaryName>
    <ProprietaryNameSuffix>Expectorant For Adults</ProprietaryNameSuffix>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040213</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Publix Super Markets Inc</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-798-00</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (59088-798-00)  *  1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2)  / 150 mL in 1 BOTTLE, DROPPER *  237 mL in 1 BOTTLE, PUMP (59088-310-16) </PackageDescription>
    <NDC11Code>59088-0798-00</NDC11Code>
    <ProductNDC>59088-798</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lextol</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230825</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230825</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61786-217-31</NDCCode>
    <PackageDescription>500 mL in 1 CONTAINER (61786-217-31)</PackageDescription>
    <NDC11Code>61786-0217-31</NDC11Code>
    <ProductNDC>61786-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>20150311</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016733</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.9</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
    <Description>Each 100 mL contains:Sodium Chloride USP 0.9 g; Water for Injection USP qs. pH adjusted with Hydrochloric Acid NFpH: 5.0 (4.5–7.0)      Calculated Osmolarity: 310 mOsmol/liter. Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154. 0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The PIC Container is PVC-free and DEHP-free.</Description>
  </NDC>
  <NDC>
    <NDCCode>64406-310-01</NDCCode>
    <PackageDescription>504 VIAL, SINGLE-USE in 1 BOX (64406-310-01)  / 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>64406-0310-01</NDC11Code>
    <ProductNDC>64406-310</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Nusinersen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20250518</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Biogen</LabelerName>
    <SubstanceName>NUSINERSEN</SubstanceName>
    <StrengthNumber>5.6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-05-31</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>18-MAY-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>72580-310-11</NDCCode>
    <PackageDescription>120 mL in 1 BOTTLE (72580-310-11) </PackageDescription>
    <NDC11Code>72580-0310-11</NDC11Code>
    <ProductNDC>72580-310</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>All Purpose Hand Sanitizing</ProprietaryName>
    <ProprietaryNameSuffix>70 Percent</ProprietaryNameSuffix>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200825</StartMarketingDate>
    <EndMarketingDate>20230731</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Formology Lab Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200825</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>85766-193-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (85766-193-05)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>85766-0193-05</NDC11Code>
    <ProductNDC>85766-193</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loteprednol Etabonate</ProprietaryName>
    <NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20231024</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215933</ApplicationNumber>
    <LabelerName>Sportpharm LLC</LabelerName>
    <SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.</IndicationAndUsage>
    <Description>Loteprednol Etabonate Ophthalmic Suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Water for Injection and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>48083-310-31</NDCCode><ProprietaryName>Certi-cet Plus</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>48083-305-31</NDCCode><ProprietaryName>Certi-antacid</ProprietaryName><NonProprietaryName>Calcium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>48083-330-31</NDCCode><ProprietaryName>Certi-sine</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>31722-310-32</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>66129-310-31</NDCCode><ProprietaryName>Crusader Skin Lightening</ProprietaryName><NonProprietaryName>Hydroquinone</NonProprietaryName></NDC><NDC><NDCCode>48083-310-27</NDCCode><ProprietaryName>Certi-cet Plus</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>48083-310-30</NDCCode><ProprietaryName>Certi-cet Plus</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>48083-310-33</NDCCode><ProprietaryName>Certi-cet Plus</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>48083-310-36</NDCCode><ProprietaryName>Certi-cet Plus</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>48083-310-39</NDCCode><ProprietaryName>Certi-cet Plus</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0264-1800-31</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0338-0143-03</NDCCode><ProprietaryName>Dextrose And Electrolyte No. 48</ProprietaryName><NonProprietaryName>Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0338-0811-04</NDCCode><ProprietaryName>Potassium Chloride In Lactated Ringers And Dextrose</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>10357-310-01</NDCCode><NonProprietaryName>Aspirin</NonProprietaryName></NDC><NDC><NDCCode>12854-310-01</NDCCode><NonProprietaryName>Fitusiran</NonProprietaryName></NDC><NDC><NDCCode>14335-310-02</NDCCode><NonProprietaryName>Gadoterate Meglumine</NonProprietaryName></NDC><NDC><NDCCode>24338-310-10</NDCCode><ProprietaryName>Ferabright</ProprietaryName><NonProprietaryName>Ferumoxytol</NonProprietaryName></NDC><NDC><NDCCode>33342-310-07</NDCCode><ProprietaryName>Lansoprazole</ProprietaryName><NonProprietaryName>Lansoprazole</NonProprietaryName></NDC><NDC><NDCCode>48581-310-55</NDCCode><NonProprietaryName>Crotamiton</NonProprietaryName></NDC><NDC><NDCCode>51655-310-53</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>55111-360-06</NDCCode><ProprietaryName>Desloratadine</ProprietaryName><NonProprietaryName>Desloratadine</NonProprietaryName></NDC><NDC><NDCCode>55111-360-31</NDCCode><ProprietaryName>Desloratadine</ProprietaryName><NonProprietaryName>Desloratadine</NonProprietaryName></NDC><NDC><NDCCode>55111-551-06</NDCCode><ProprietaryName>Desloratadine</ProprietaryName><NonProprietaryName>Desloratadine</NonProprietaryName></NDC><NDC><NDCCode>55111-551-31</NDCCode><ProprietaryName>Desloratadine</ProprietaryName><NonProprietaryName>Desloratadine</NonProprietaryName></NDC><NDC><NDCCode>56062-310-34</NDCCode><ProprietaryName>Tussin</ProprietaryName><NonProprietaryName>Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>59088-798-00</NDCCode><ProprietaryName>Lextol</ProprietaryName><NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName></NDC><NDC><NDCCode>61786-217-31</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>64406-310-01</NDCCode><NonProprietaryName>Nusinersen</NonProprietaryName></NDC><NDC><NDCCode>72580-310-11</NDCCode><ProprietaryName>All Purpose Hand Sanitizing</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>85766-193-05</NDCCode><ProprietaryName>Loteprednol Etabonate</ProprietaryName><NonProprietaryName>Loteprednol Etabonate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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