RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "84549-147-02",
      "PackageDescription": "250 mL in 1 BOTTLE, GLASS (84549-147-02) ",
      "NDC11Code": "84549-0147-02",
      "ProductNDC": "84549-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitroglycerin In Dextrose",
      "NonProprietaryName": "Nitroglycerin",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19891229",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019970",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "NITROGLYCERIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension.",
      "Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. whose empiric formula is C 3H 5N 3O 9, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Dextrose (Dextrose Hydrous, USP) is D-glucose monohydrate, a hexose sugar whose structural formula is. whose empiric formula is C 6H 12O 6 H 2O, and whose molecular weight is 198.17. Dextrose is derived from corn. Nitroglycerin in 5% Dextrose Injection is a sterile, nonpyrogenic solution of nitroglycerin and dextrose in water for injection. The solution is clear and practically colorless. Each 100 mL contains 10 mg, 20 mg, or 40 mg nitroglycerin (added as Diluted Nitroglycerin, USP with propylene glycol); 5 g Dextrose Hydrous, USP; 0.84 mL Alcohol, USP (added as a dissolution aid); and 105 mg Citric Acid Hydrous, USP (added as a buffer). The pH of the solution is adjusted with sodium hydroxide and, if necessary, hydrochloric acid. Although dry nitroglycerin is explosive, nitroglycerin in 5% dextrose is not. Composition, osmolarity and pH are given in Table 1."
    },
    {
      "NDCCode": "84549-007-02",
      "PackageDescription": "250 mL in 1 BAG (84549-007-02) ",
      "NDC11Code": "84549-0007-02",
      "ProductNDC": "84549-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dopamine Hydrochloride And Dextrose",
      "NonProprietaryName": "Dopamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19870327",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019615",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "DOPAMINE HYDROCHLORIDE",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250917",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
      "Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USPprovides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USPprovides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USPprovides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. 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": "84549-162-02",
      "PackageDescription": "30 mL in 1 VIAL, SINGLE-DOSE (84549-162-02) ",
      "NDC11Code": "84549-0162-02",
      "ProductNDC": "84549-162",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hydrochloride",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20051122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070584",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
      "Description": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)] . Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula:. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007."
    },
    {
      "NDCCode": "84549-259-02",
      "PackageDescription": "30 mL in 1 VIAL, SINGLE-DOSE (84549-259-02) ",
      "NDC11Code": "84549-0259-02",
      "ProductNDC": "84549-259",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hydrochloride",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20050506",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070583",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
      "Description": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)] . Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula:. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007."
    },
    {
      "NDCCode": "84549-276-02",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (84549-276-02) ",
      "NDC11Code": "84549-0276-02",
      "ProductNDC": "84549-276",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine Hydrochloride",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20050712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088299",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
      "Description": "Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIEDsection for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
    },
    {
      "NDCCode": "84549-277-02",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (84549-277-02) ",
      "NDC11Code": "84549-0277-02",
      "ProductNDC": "84549-277",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine Hydrochloride",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20050615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088327",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
      "Description": "Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIEDsection for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
    },
    {
      "NDCCode": "84549-318-02",
      "PackageDescription": "2 mL in 1 VIAL (84549-318-02) ",
      "NDC11Code": "84549-0318-02",
      "ProductNDC": "84549-318",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adenosine",
      "NonProprietaryName": "Adenosine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206778",
      "LabelerName": "ProPharma Distribution",
      "SubstanceName": "ADENOSINE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250827",
      "SamplePackage": "N",
      "IndicationAndUsage": "Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine Injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.",
      "Description": "Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in Water for Injection. The pH of the solution is between 4.5 and 7.5."
    },
    {
      "NDCCode": "10812-034-02",
      "PackageDescription": "147 mL in 1 TUBE (10812-034-02)",
      "NDC11Code": "10812-0034-02",
      "ProductNDC": "10812-034",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Naturals Acne Cleanser",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Neutrogena Corporation",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "10812-322-02",
      "PackageDescription": "147 mL in 1 TUBE (10812-322-02)",
      "NDC11Code": "10812-0322-02",
      "ProductNDC": "10812-322",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Pure And Free Baby Sunblock",
      "ProprietaryNameSuffix": "Spf 60plus Purescreen",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101201",
      "EndMarketingDate": "20151015",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Neutrogena Corporation",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "49; 47",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "10812-431-02",
      "PackageDescription": "147 mL in 1 TUBE (10812-431-02)",
      "NDC11Code": "10812-0431-02",
      "ProductNDC": "10812-431",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Pure And Free Baby",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf60 Plus",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "49; 47",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-05",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10812-449-02",
      "PackageDescription": "147 mL in 1 BOTTLE (10812-449-02) ",
      "NDC11Code": "10812-0449-02",
      "ProductNDC": "10812-449",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Cooldry Sport With Micromesh",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf 30",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "30; 80; 50; 40; 40",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20140901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10812-452-02",
      "PackageDescription": "147 mL in 1 BOTTLE (10812-452-02) ",
      "NDC11Code": "10812-0452-02",
      "ProductNDC": "10812-452",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Cooldry Sport With Micromesh",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf 50",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "27; 90; 45; 80; 45",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20150901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "14096-147-02",
      "PackageDescription": "10 kg in 1 DRUM (14096-147-02) ",
      "NDC11Code": "14096-0147-02",
      "ProductNDC": "14096-147",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Busulfan",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110701",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Apicore US LLC",
      "SubstanceName": "BUSULFAN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-APR-16"
    },
    {
      "NDCCode": "14445-147-10",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (14445-147-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-147-02) ",
      "NDC11Code": "14445-0147-10",
      "ProductNDC": "14445-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rivaroxaban",
      "NonProprietaryName": "Rivaroxaban",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218445",
      "LabelerName": "Indoco Remedies Limited",
      "SubstanceName": "RIVAROXABAN",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250811",
      "SamplePackage": "N",
      "IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
      "Description": "Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow  and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red."
    },
    {
      "NDCCode": "25280-004-02",
      "PackageDescription": "59.147 mL in 1 BOTTLE, PLASTIC (25280-004-02)",
      "NDC11Code": "25280-0004-02",
      "ProductNDC": "25280-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loesch",
      "ProprietaryNameSuffix": "Anti-itch Therapy",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140626",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Loesch Laboratory Consultants, Inc.",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Specially formulated to rapidly and completely penetrate the scalp (or skin) delivering itch relief anywhere it's needed. This liquid preparation can be applied to the skin or scalp to temporarily relieve minor itching and skin irritations commonly associated with insect bites, poison oak, poison sumac, and skin blemishes."
    },
    {
      "NDCCode": "31645-147-02",
      "PackageDescription": "1 CONTAINER in 1 BOX (31645-147-02)  > 14 g in 1 CONTAINER (31645-147-01) ",
      "NDC11Code": "31645-0147-02",
      "ProductNDC": "31645-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mineral Wear Talc-free Mineral Loose Powder",
      "ProprietaryNameSuffix": "Spf 16",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20080101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Physicians Formula Inc",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "12; 4.2",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20080101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42508-147-02",
      "PackageDescription": "1 TUBE in 1 CARTON (42508-147-02)  > 50 mL in 1 TUBE (42508-147-01)",
      "NDC11Code": "42508-0147-02",
      "ProductNDC": "42508-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sheer Finish Tinted Moisturizer Medium-beige",
      "ProprietaryNameSuffix": "Spf 15",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100301",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Arbonne International, LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "42973-147-02",
      "PackageDescription": "50 kg in 1 DRUM (42973-147-02)",
      "NDC11Code": "42973-0147-02",
      "ProductNDC": "42973-147",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Busulfan",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20091115",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Apicore Pharmaceuticals Private Limited",
      "SubstanceName": "BUSULFAN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "43858-147-02",
      "PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (43858-147-02)  > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE",
      "NDC11Code": "43858-0147-02",
      "ProductNDC": "43858-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Piperacillin And Tazobactam",
      "NonProprietaryName": "Piperacillin And Tazobactam",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS; PARENTERAL",
      "StartMarketingDate": "20101021",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065363",
      "LabelerName": "Sandoz GmbH",
      "SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
      "StrengthNumber": "3; .375",
      "StrengthUnit": "g/1; g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-03-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20101021",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49404-147-02",
      "PackageDescription": "10 mL in 1 JAR (49404-147-02) ",
      "NDC11Code": "49404-0147-02",
      "ProductNDC": "49404-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr.jart Cicapair Tiger Grass Color Correcting Treatment",
      "NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20211028",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Have & Be Co., Ltd.",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "5.8; 2.8",
      "StrengthUnit": "g/100mL; g/100mL",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211028",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52651-057-02",
      "PackageDescription": "147 mL in 1 BOTTLE, PUMP (52651-057-02) ",
      "NDC11Code": "52651-0057-02",
      "ProductNDC": "52651-057",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tn Dickinsons Medicated Cooling Foam Hemorrhoidal Relief",
      "NonProprietaryName": "Witch Hazel",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250315",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "Dickinson Brands Inc.",
      "SubstanceName": "WITCH HAZEL",
      "StrengthNumber": ".4",
      "StrengthUnit": "g/mL",
      "Status": "Active",
      "LastUpdate": "2025-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250315",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps relieve local burning, itching and discomfort associated with hemorrhoids and perineal area. aids in the protection of irritated or inflamed anorectal areas."
    },
    {
      "NDCCode": "54340-147-02",
      "PackageDescription": "325 mL in 1 BOTTLE, DISPENSING (54340-147-02) ",
      "NDC11Code": "54340-0147-02",
      "ProductNDC": "54340-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dial Complete Lhs Lemon And Sage",
      "NonProprietaryName": "Liquid Hand Soap Lemon And Sage",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Henkel Corporation",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwasing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "54575-147-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-147-02)",
      "NDC11Code": "54575-0147-02",
      "ProductNDC": "54575-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Short Ragweed Pollen",
      "NonProprietaryName": "Ambrosia Artemisiifolia Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19820126",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101387",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "AMBROSIA ARTEMISIIFOLIA POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/10mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "57627-147-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (57627-147-02)  > 13 g in 1 CONTAINER (57627-147-01)",
      "NDC11Code": "57627-0147-02",
      "ProductNDC": "57627-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Porcelain Smart Finish Makeup Broad Spectrum Spf 18",
      "ProprietaryNameSuffix": "Merle Norman",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110503",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Merle Norman",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "2.25",
      "StrengthUnit": "g/13g",
      "Status": "Deprecated",
      "LastUpdate": "2014-04-22"
    },
    {
      "NDCCode": "63545-147-02",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (63545-147-02) ",
      "NDC11Code": "63545-0147-02",
      "ProductNDC": "63545-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aloe Socotrina",
      "NonProprietaryName": "Aloe Socotrina",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200113",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ALOE",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200113",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64117-147-02",
      "PackageDescription": "7.5 mL in 1 BOTTLE, GLASS (64117-147-02) ",
      "NDC11Code": "64117-0147-02",
      "ProductNDC": "64117-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Toothache Neuralgia",
      "NonProprietaryName": "Hekla Lava",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980604",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Natural Health Supply",
      "SubstanceName": "HEKLA LAVA",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19980604",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indications: To be used for acute self-limiting conditions according to standard homeopathic indications."
    },
    {
      "NDCCode": "65278-106-02",
      "PackageDescription": "147.87 g in 1 CARTON (65278-106-02) ",
      "NDC11Code": "65278-0106-02",
      "ProductNDC": "65278-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-aging Blemish Control Cleanser",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100408",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "June Jacobs Labs, LLC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "1.4787",
      "StrengthUnit": "g/147.87g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100408",
      "SamplePackage": "N",
      "IndicationAndUsage": "USE. For the treatment, Control and prevention of Acne."
    },
    {
      "NDCCode": "65923-147-02",
      "PackageDescription": "1 PATCH in 1 POUCH (65923-147-02)  > 1 g in 1 PATCH",
      "NDC11Code": "65923-0147-02",
      "ProductNDC": "65923-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Coralite Cold And Hot Medicated",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181023",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "United Exchange Corporation",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20181023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: 1 open pouch and remove patch, 2 carefully peel off protective backing and apply sticky side to affected area, 3 adults and children 12 years of age and older:, 4 do not wear patch for more than 8 hours, 5 apply to affected area no more than 3 times daily, 6 children under 12 years of age: consult a doctor."
    },
    {
      "NDCCode": "67751-147-02",
      "PackageDescription": "2 POUCH in 1 CARTON (67751-147-02)  / 4 TABLET, COATED in 1 POUCH",
      "NDC11Code": "67751-0147-02",
      "ProductNDC": "67751-147",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Advil Pm",
      "NonProprietaryName": "Diphenhydramine Citrate, Ibuprofen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160916",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021394",
      "LabelerName": "Navajo Manufacturing Company Inc.",
      "SubstanceName": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
      "StrengthNumber": "38; 200",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160916",
      "SamplePackage": "N",
      "IndicationAndUsage": " for relief of occasional sleeplessness when associated with minor aches and pains   helps you fall asleep and stay asleep."
    },
    {
      "NDCCode": "71052-147-02",
      "PackageDescription": "5 g in 1 BOTTLE (71052-147-02) ",
      "NDC11Code": "71052-0147-02",
      "ProductNDC": "71052-147",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Idoxurudine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170901",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Darmerica, LLC",
      "SubstanceName": "IDOXURIDINE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "01-SEP-17"
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>84549-147-02</NDCCode>
    <PackageDescription>250 mL in 1 BOTTLE, GLASS (84549-147-02) </PackageDescription>
    <NDC11Code>84549-0147-02</NDC11Code>
    <ProductNDC>84549-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitroglycerin In Dextrose</ProprietaryName>
    <NonProprietaryName>Nitroglycerin</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19891229</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019970</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>NITROGLYCERIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension.</IndicationAndUsage>
    <Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. whose empiric formula is C 3H 5N 3O 9, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Dextrose (Dextrose Hydrous, USP) is D-glucose monohydrate, a hexose sugar whose structural formula is. whose empiric formula is C 6H 12O 6 H 2O, and whose molecular weight is 198.17. Dextrose is derived from corn. Nitroglycerin in 5% Dextrose Injection is a sterile, nonpyrogenic solution of nitroglycerin and dextrose in water for injection. The solution is clear and practically colorless. Each 100 mL contains 10 mg, 20 mg, or 40 mg nitroglycerin (added as Diluted Nitroglycerin, USP with propylene glycol); 5 g Dextrose Hydrous, USP; 0.84 mL Alcohol, USP (added as a dissolution aid); and 105 mg Citric Acid Hydrous, USP (added as a buffer). The pH of the solution is adjusted with sodium hydroxide and, if necessary, hydrochloric acid. Although dry nitroglycerin is explosive, nitroglycerin in 5% dextrose is not. Composition, osmolarity and pH are given in Table 1.</Description>
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  <NDC>
    <NDCCode>84549-007-02</NDCCode>
    <PackageDescription>250 mL in 1 BAG (84549-007-02) </PackageDescription>
    <NDC11Code>84549-0007-02</NDC11Code>
    <ProductNDC>84549-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
    <NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19870327</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019615</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
    <Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USPprovides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USPprovides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USPprovides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. 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>
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  <NDC>
    <NDCCode>84549-162-02</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, SINGLE-DOSE (84549-162-02) </PackageDescription>
    <NDC11Code>84549-0162-02</NDC11Code>
    <ProductNDC>84549-162</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
    <StartMarketingDate>20051122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070584</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
    <Description>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)] . Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula:. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007.</Description>
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  <NDC>
    <NDCCode>84549-259-02</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, SINGLE-DOSE (84549-259-02) </PackageDescription>
    <NDC11Code>84549-0259-02</NDC11Code>
    <ProductNDC>84549-259</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
    <StartMarketingDate>20050506</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070583</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
    <Description>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)] . Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula:. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007.</Description>
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  <NDC>
    <NDCCode>84549-276-02</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (84549-276-02) </PackageDescription>
    <NDC11Code>84549-0276-02</NDC11Code>
    <ProductNDC>84549-276</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20050712</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088299</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIEDsection for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
  </NDC>
  <NDC>
    <NDCCode>84549-277-02</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (84549-277-02) </PackageDescription>
    <NDC11Code>84549-0277-02</NDC11Code>
    <ProductNDC>84549-277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20050615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088327</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIEDsection for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
  </NDC>
  <NDC>
    <NDCCode>84549-318-02</NDCCode>
    <PackageDescription>2 mL in 1 VIAL (84549-318-02) </PackageDescription>
    <NDC11Code>84549-0318-02</NDC11Code>
    <ProductNDC>84549-318</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adenosine</ProprietaryName>
    <NonProprietaryName>Adenosine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206778</ApplicationNumber>
    <LabelerName>ProPharma Distribution</LabelerName>
    <SubstanceName>ADENOSINE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Intravenous adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION). Adenosine Injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.</IndicationAndUsage>
    <Description>Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in Water for Injection. The pH of the solution is between 4.5 and 7.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>10812-034-02</NDCCode>
    <PackageDescription>147 mL in 1 TUBE (10812-034-02)</PackageDescription>
    <NDC11Code>10812-0034-02</NDC11Code>
    <ProductNDC>10812-034</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Naturals Acne Cleanser</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>Neutrogena Corporation</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10812-322-02</NDCCode>
    <PackageDescription>147 mL in 1 TUBE (10812-322-02)</PackageDescription>
    <NDC11Code>10812-0322-02</NDC11Code>
    <ProductNDC>10812-322</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Pure And Free Baby Sunblock</ProprietaryName>
    <ProprietaryNameSuffix>Spf 60plus Purescreen</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101201</StartMarketingDate>
    <EndMarketingDate>20151015</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Neutrogena Corporation</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>49; 47</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10812-431-02</NDCCode>
    <PackageDescription>147 mL in 1 TUBE (10812-431-02)</PackageDescription>
    <NDC11Code>10812-0431-02</NDC11Code>
    <ProductNDC>10812-431</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf60 Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>49; 47</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-05</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10812-449-02</NDCCode>
    <PackageDescription>147 mL in 1 BOTTLE (10812-449-02) </PackageDescription>
    <NDC11Code>10812-0449-02</NDC11Code>
    <ProductNDC>10812-449</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Cooldry Sport With Micromesh</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>30; 80; 50; 40; 40</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-08-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10812-452-02</NDCCode>
    <PackageDescription>147 mL in 1 BOTTLE (10812-452-02) </PackageDescription>
    <NDC11Code>10812-0452-02</NDC11Code>
    <ProductNDC>10812-452</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Cooldry Sport With Micromesh</ProprietaryName>
    <ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf 50</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>27; 90; 45; 80; 45</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>14096-147-02</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (14096-147-02) </PackageDescription>
    <NDC11Code>14096-0147-02</NDC11Code>
    <ProductNDC>14096-147</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Busulfan</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110701</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Apicore US LLC</LabelerName>
    <SubstanceName>BUSULFAN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-APR-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14445-147-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (14445-147-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-147-02) </PackageDescription>
    <NDC11Code>14445-0147-10</NDC11Code>
    <ProductNDC>14445-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivaroxaban</ProprietaryName>
    <NonProprietaryName>Rivaroxaban</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218445</ApplicationNumber>
    <LabelerName>Indoco Remedies Limited</LabelerName>
    <SubstanceName>RIVAROXABAN</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
    <Description>Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow  and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>25280-004-02</NDCCode>
    <PackageDescription>59.147 mL in 1 BOTTLE, PLASTIC (25280-004-02)</PackageDescription>
    <NDC11Code>25280-0004-02</NDC11Code>
    <ProductNDC>25280-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Loesch</ProprietaryName>
    <ProprietaryNameSuffix>Anti-itch Therapy</ProprietaryNameSuffix>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140626</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Loesch Laboratory Consultants, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Specially formulated to rapidly and completely penetrate the scalp (or skin) delivering itch relief anywhere it's needed. This liquid preparation can be applied to the skin or scalp to temporarily relieve minor itching and skin irritations commonly associated with insect bites, poison oak, poison sumac, and skin blemishes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31645-147-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 BOX (31645-147-02)  &gt; 14 g in 1 CONTAINER (31645-147-01) </PackageDescription>
    <NDC11Code>31645-0147-02</NDC11Code>
    <ProductNDC>31645-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Wear Talc-free Mineral Loose Powder</ProprietaryName>
    <ProprietaryNameSuffix>Spf 16</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Physicians Formula Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>12; 4.2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42508-147-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (42508-147-02)  &gt; 50 mL in 1 TUBE (42508-147-01)</PackageDescription>
    <NDC11Code>42508-0147-02</NDC11Code>
    <ProductNDC>42508-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sheer Finish Tinted Moisturizer Medium-beige</ProprietaryName>
    <ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Arbonne International, LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42973-147-02</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (42973-147-02)</PackageDescription>
    <NDC11Code>42973-0147-02</NDC11Code>
    <ProductNDC>42973-147</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Busulfan</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20091115</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Apicore Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>BUSULFAN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43858-147-02</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (43858-147-02)  &gt; 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>43858-0147-02</NDC11Code>
    <ProductNDC>43858-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
    <NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; PARENTERAL</RouteName>
    <StartMarketingDate>20101021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065363</ApplicationNumber>
    <LabelerName>Sandoz GmbH</LabelerName>
    <SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
    <StrengthNumber>3; .375</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-03-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49404-147-02</NDCCode>
    <PackageDescription>10 mL in 1 JAR (49404-147-02) </PackageDescription>
    <NDC11Code>49404-0147-02</NDC11Code>
    <ProductNDC>49404-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr.jart Cicapair Tiger Grass Color Correcting Treatment</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20211028</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Have &amp; Be Co., Ltd.</LabelerName>
    <SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>5.8; 2.8</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52651-057-02</NDCCode>
    <PackageDescription>147 mL in 1 BOTTLE, PUMP (52651-057-02) </PackageDescription>
    <NDC11Code>52651-0057-02</NDC11Code>
    <ProductNDC>52651-057</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tn Dickinsons Medicated Cooling Foam Hemorrhoidal Relief</ProprietaryName>
    <NonProprietaryName>Witch Hazel</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250315</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M015</ApplicationNumber>
    <LabelerName>Dickinson Brands Inc.</LabelerName>
    <SubstanceName>WITCH HAZEL</SubstanceName>
    <StrengthNumber>.4</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps relieve local burning, itching and discomfort associated with hemorrhoids and perineal area. aids in the protection of irritated or inflamed anorectal areas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54340-147-02</NDCCode>
    <PackageDescription>325 mL in 1 BOTTLE, DISPENSING (54340-147-02) </PackageDescription>
    <NDC11Code>54340-0147-02</NDC11Code>
    <ProductNDC>54340-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dial Complete Lhs Lemon And Sage</ProprietaryName>
    <NonProprietaryName>Liquid Hand Soap Lemon And Sage</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Henkel Corporation</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.13</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwasing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54575-147-02</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-147-02)</PackageDescription>
    <NDC11Code>54575-0147-02</NDC11Code>
    <ProductNDC>54575-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Short Ragweed Pollen</ProprietaryName>
    <NonProprietaryName>Ambrosia Artemisiifolia Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19820126</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101387</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>AMBROSIA ARTEMISIIFOLIA POLLEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/10mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>57627-147-02</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (57627-147-02)  &gt; 13 g in 1 CONTAINER (57627-147-01)</PackageDescription>
    <NDC11Code>57627-0147-02</NDC11Code>
    <ProductNDC>57627-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Porcelain Smart Finish Makeup Broad Spectrum Spf 18</ProprietaryName>
    <ProprietaryNameSuffix>Merle Norman</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110503</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Merle Norman</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>2.25</StrengthNumber>
    <StrengthUnit>g/13g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-04-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63545-147-02</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (63545-147-02) </PackageDescription>
    <NDC11Code>63545-0147-02</NDC11Code>
    <ProductNDC>63545-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aloe Socotrina</ProprietaryName>
    <NonProprietaryName>Aloe Socotrina</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200113</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
    <SubstanceName>ALOE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>64117-147-02</NDCCode>
    <PackageDescription>7.5 mL in 1 BOTTLE, GLASS (64117-147-02) </PackageDescription>
    <NDC11Code>64117-0147-02</NDC11Code>
    <ProductNDC>64117-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Toothache Neuralgia</ProprietaryName>
    <NonProprietaryName>Hekla Lava</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980604</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Natural Health Supply</LabelerName>
    <SubstanceName>HEKLA LAVA</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indications: To be used for acute self-limiting conditions according to standard homeopathic indications.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65278-106-02</NDCCode>
    <PackageDescription>147.87 g in 1 CARTON (65278-106-02) </PackageDescription>
    <NDC11Code>65278-0106-02</NDC11Code>
    <ProductNDC>65278-106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anti-aging Blemish Control Cleanser</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100408</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>June Jacobs Labs, LLC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>1.4787</StrengthNumber>
    <StrengthUnit>g/147.87g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100408</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USE. For the treatment, Control and prevention of Acne.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65923-147-02</NDCCode>
    <PackageDescription>1 PATCH in 1 POUCH (65923-147-02)  &gt; 1 g in 1 PATCH</PackageDescription>
    <NDC11Code>65923-0147-02</NDC11Code>
    <ProductNDC>65923-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Coralite Cold And Hot Medicated</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181023</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>United Exchange Corporation</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions: 1 open pouch and remove patch, 2 carefully peel off protective backing and apply sticky side to affected area, 3 adults and children 12 years of age and older:, 4 do not wear patch for more than 8 hours, 5 apply to affected area no more than 3 times daily, 6 children under 12 years of age: consult a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67751-147-02</NDCCode>
    <PackageDescription>2 POUCH in 1 CARTON (67751-147-02)  / 4 TABLET, COATED in 1 POUCH</PackageDescription>
    <NDC11Code>67751-0147-02</NDC11Code>
    <ProductNDC>67751-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advil Pm</ProprietaryName>
    <NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160916</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021394</ApplicationNumber>
    <LabelerName>Navajo Manufacturing Company Inc.</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
    <StrengthNumber>38; 200</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> for relief of occasional sleeplessness when associated with minor aches and pains   helps you fall asleep and stay asleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71052-147-02</NDCCode>
    <PackageDescription>5 g in 1 BOTTLE (71052-147-02) </PackageDescription>
    <NDC11Code>71052-0147-02</NDC11Code>
    <ProductNDC>71052-147</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Idoxurudine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Darmerica, LLC</LabelerName>
    <SubstanceName>IDOXURIDINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-SEP-17</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>84549-147-02</NDCCode><ProprietaryName>Nitroglycerin In Dextrose</ProprietaryName><NonProprietaryName>Nitroglycerin</NonProprietaryName></NDC><NDC><NDCCode>84549-007-02</NDCCode><ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName><NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>84549-162-02</NDCCode><ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>84549-259-02</NDCCode><ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>84549-276-02</NDCCode><ProprietaryName>Lidocaine Hydrochloride</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>84549-277-02</NDCCode><ProprietaryName>Lidocaine Hydrochloride</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>84549-318-02</NDCCode><ProprietaryName>Adenosine</ProprietaryName><NonProprietaryName>Adenosine</NonProprietaryName></NDC><NDC><NDCCode>10812-034-02</NDCCode><ProprietaryName>Neutrogena Naturals Acne Cleanser</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>10812-322-02</NDCCode><ProprietaryName>Neutrogena Pure And Free Baby Sunblock</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10812-431-02</NDCCode><ProprietaryName>Neutrogena Pure And Free Baby</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10812-449-02</NDCCode><ProprietaryName>Neutrogena Cooldry Sport With Micromesh</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>10812-452-02</NDCCode><ProprietaryName>Neutrogena Cooldry Sport With Micromesh</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>14096-147-02</NDCCode><NonProprietaryName>Busulfan</NonProprietaryName></NDC><NDC><NDCCode>14445-147-10</NDCCode><ProprietaryName>Rivaroxaban</ProprietaryName><NonProprietaryName>Rivaroxaban</NonProprietaryName></NDC><NDC><NDCCode>25280-004-02</NDCCode><ProprietaryName>Loesch</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>31645-147-02</NDCCode><ProprietaryName>Mineral Wear Talc-free Mineral Loose Powder</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>42508-147-02</NDCCode><ProprietaryName>Sheer Finish Tinted Moisturizer Medium-beige</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>42973-147-02</NDCCode><NonProprietaryName>Busulfan</NonProprietaryName></NDC><NDC><NDCCode>43858-147-02</NDCCode><ProprietaryName>Piperacillin And Tazobactam</ProprietaryName><NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName></NDC><NDC><NDCCode>49404-147-02</NDCCode><ProprietaryName>Dr.jart Cicapair Tiger Grass Color Correcting Treatment</ProprietaryName><NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>52651-057-02</NDCCode><ProprietaryName>Tn Dickinsons Medicated Cooling Foam Hemorrhoidal Relief</ProprietaryName><NonProprietaryName>Witch Hazel</NonProprietaryName></NDC><NDC><NDCCode>54340-147-02</NDCCode><ProprietaryName>Dial Complete Lhs Lemon And Sage</ProprietaryName><NonProprietaryName>Liquid Hand Soap Lemon And Sage</NonProprietaryName></NDC><NDC><NDCCode>54575-147-02</NDCCode><ProprietaryName>Standardized Short Ragweed Pollen</ProprietaryName><NonProprietaryName>Ambrosia Artemisiifolia Pollen</NonProprietaryName></NDC><NDC><NDCCode>57627-147-02</NDCCode><ProprietaryName>Porcelain Smart Finish Makeup Broad Spectrum Spf 18</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>63545-147-02</NDCCode><ProprietaryName>Aloe Socotrina</ProprietaryName><NonProprietaryName>Aloe Socotrina</NonProprietaryName></NDC><NDC><NDCCode>64117-147-02</NDCCode><ProprietaryName>Toothache Neuralgia</ProprietaryName><NonProprietaryName>Hekla Lava</NonProprietaryName></NDC><NDC><NDCCode>65278-106-02</NDCCode><ProprietaryName>Anti-aging Blemish Control Cleanser</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>65923-147-02</NDCCode><ProprietaryName>Coralite Cold And Hot Medicated</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>67751-147-02</NDCCode><ProprietaryName>Advil Pm</ProprietaryName><NonProprietaryName>Diphenhydramine Citrate, Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>71052-147-02</NDCCode><NonProprietaryName>Idoxurudine</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",
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      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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