RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "43602-283-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-283-05) ",
      "NDC11Code": "43602-0283-05",
      "ProductNDC": "43602-283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214422",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201230",
      "SamplePackage": "N",
      "IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
      "Description": "Potassium Chloride Extended-Release Tablets, USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 750 mg of microencapsulated potassium chloride, equivalent to 10 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 15 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,125 mg of microencapsulated potassium chloride, equivalent to 15 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,500 mg of microencapsulated potassium chloride, equivalent to 20 mEq K of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended-Release Tablets, USP is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended-Release Tablets, USP is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended-Release Tablets, USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP. FDA approved sample preparation in the assay differs from USP test."
    },
    {
      "NDCCode": "43602-283-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-283-30) ",
      "NDC11Code": "43602-0283-30",
      "ProductNDC": "43602-283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214422",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201230",
      "SamplePackage": "N",
      "IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
      "Description": "Potassium Chloride Extended-Release Tablets, USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 750 mg of microencapsulated potassium chloride, equivalent to 10 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 15 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,125 mg of microencapsulated potassium chloride, equivalent to 15 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,500 mg of microencapsulated potassium chloride, equivalent to 20 mEq K of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended-Release Tablets, USP is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended-Release Tablets, USP is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended-Release Tablets, USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP. FDA approved sample preparation in the assay differs from USP test."
    },
    {
      "NDCCode": "13107-283-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (13107-283-05) ",
      "NDC11Code": "13107-0283-05",
      "ProductNDC": "13107-283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clorazepate Dipotassium",
      "NonProprietaryName": "Clorazepate Dipotassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230923",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071858",
      "LabelerName": "Aurolife Pharma LLC",
      "SubstanceName": "CLORAZEPATE DIPOTASSIUM",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230923",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of  clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.",
      "Description": "Chemically, clorazepate dipotassium is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows. The compound occurs as a fine, white or light yellow crystalline powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate dipotassium tablets, USP contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP for oral administration. Inactive ingredients for clorazepate dipotassium tablets: croscarmellose sodium, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, sodium chloride and sodium lauryl sulfate. The 3.75 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and the 7.5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake."
    },
    {
      "NDCCode": "36800-283-05",
      "PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (36800-283-05)  > 100 TABLET in 1 BOTTLE, PLASTIC",
      "NDC11Code": "36800-0283-05",
      "ProductNDC": "36800-283",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Headache Relief",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen, Aspirin And Caffeine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160101",
      "EndMarketingDate": "20220131",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "TopCo Associates LLC",
      "SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
      "StrengthNumber": "250; 250; 65",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160101",
      "EndMarketingDatePackage": "20220131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50383-283-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50383-283-05)  > 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "50383-0283-05",
      "ProductNDC": "50383-283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20110210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076826",
      "LabelerName": "Hi-Tech Pharmacal Co., Inc.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-08",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "59137-283-05",
      "PackageDescription": "1 KIT in 1 CARTON (59137-283-05)  *  5 mL in 1 VIAL (59137-271-01)  *  5 mL in 1 SYRINGE (59137-280-01) ",
      "NDC11Code": "59137-0283-05",
      "ProductNDC": "59137-283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ixinity",
      "NonProprietaryName": "Coagulation Factor Ix (recombinant)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170512",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125426",
      "LabelerName": "Medexus Pharma, Inc.",
      "Status": "Active",
      "LastUpdate": "2024-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210701",
      "SamplePackage": "N",
      "IndicationAndUsage": "IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
      "Description": "IXINITY [coagulation factor IX (recombinant)] is a purified protein that has 415 amino acids. It has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. Coagulation factor IX (recombinant) is a single-chain glycoprotein with a molecular mass of about 55,000 Dalton that is secreted by a genetically engineered mammalian cell line derived from Chinese hamster ovary (CHO) cells. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain hormones. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal, namely, solvent/detergent treatment, a chromatographic step, and nanofiltration. The process also includes a validated step to reduce the presence of CHO proteins in the final drug product. IXINITY is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-dose vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are."
    },
    {
      "NDCCode": "59746-283-05",
      "PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (59746-283-05) ",
      "NDC11Code": "59746-0283-05",
      "ProductNDC": "59746-283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium",
      "NonProprietaryName": "Pantoprazole Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090901",
      "LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-283-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-283-05) ",
      "NDC11Code": "68428-0283-05",
      "ProductNDC": "68428-283",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Candida Albicans",
      "NonProprietaryName": "Candida Albicans",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100204",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "CANDIDA ALBICANS",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100204",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "72865-283-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (72865-283-05) ",
      "NDC11Code": "72865-0283-05",
      "ProductNDC": "72865-283",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxcarbazepine",
      "NonProprietaryName": "Oxcarbazepine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215939",
      "LabelerName": "XLCare Pharmaceuticals Inc.",
      "SubstanceName": "OXCARBAZEPINE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-07-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240718",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
      "Description": "Oxcarbazepine is an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine USP is a light orange to creamish white or off-white powder. Sparingly soluble in acetic acid, slightly soluble in chloroform and practically insoluble in water.  Its molecular weight is 252.268. Oxcarbazepine film-coated tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, black iron oxide, iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
    },
    {
      "NDCCode": "77040-283-05",
      "PackageDescription": "18927 mL in 1 PAIL (77040-283-05) ",
      "NDC11Code": "77040-0283-05",
      "ProductNDC": "77040-283",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arropure 70f",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200811",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "ARROPOL Chemicals, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200812",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "82699-307-05",
      "PackageDescription": "283.6 g in 1 PACKAGE (82699-307-05) ",
      "NDC11Code": "82699-0307-05",
      "ProductNDC": "82699-307",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Right Guard Xtreme Humidity Breaker Antiperspirant Cold Front Invisible Solid",
      "NonProprietaryName": "Right Guard Xtreme Humidity Breaker Antiperspirant Cold Front Invisible Solid",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M019",
      "LabelerName": "Thriving Brands LLC",
      "SubstanceName": "ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY",
      "StrengthNumber": "16.4",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "83324-282-05",
      "PackageDescription": "1 KIT in 1 KIT (83324-282-05)  *  1 BOTTLE, DISPENSING in 1 BOX (83324-283-05)  / 15 mL in 1 BOTTLE, DISPENSING",
      "NDC11Code": "83324-0282-05",
      "ProductNDC": "83324-282",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quality Choice Earwax Removal Kit Earwax Removal Aid And Bulb",
      "NonProprietaryName": "Carbamide Peroxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20260601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Chain Drug Marketing Association, Inc.",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260601",
      "SamplePackage": "N",
      "IndicationAndUsage": "for occasional use as an aid to soften, loosen, and remove excessive earwax."
    },
    {
      "NDCCode": "83324-283-05",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 BOX (83324-283-05)  / 15 mL in 1 BOTTLE, DISPENSING",
      "NDC11Code": "83324-0283-05",
      "ProductNDC": "83324-283",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quality Choice Earwax Removal Drops Earwax Removal Aid",
      "NonProprietaryName": "Carbamide Peroxide",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M014",
      "LabelerName": "Chain Drug Marketing Association, Inc.",
      "SubstanceName": "CARBAMIDE PEROXIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260601",
      "SamplePackage": "N",
      "IndicationAndUsage": "for occasional use as an aid to soften, loosen, and remove excessive earwax."
    },
    {
      "NDCCode": "84756-283-05",
      "PackageDescription": "100 mL in 1 BOTTLE (84756-283-05) ",
      "NDC11Code": "84756-0283-05",
      "ProductNDC": "84756-283",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Hair Essential Oil",
      "NonProprietaryName": "Trstay Hair Essential Oil",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241105",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "43602-002-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (43602-002-05) ",
      "NDC11Code": "43602-0002-05",
      "ProductNDC": "43602-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210506",
      "LabelerName": "Ascent Pharmaceuticals Inc",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Hydromorphone Hydrochloride, USP, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone Hydrochloride Tablets, USP are supplied in 2 mg, 4 mg, and 8 mg tablets for oral administration. The tablet strengths describe the amount of Hydromorphone Hydrochloride in each tablet. The chemical name is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular Weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure. Hydromorphone Hydrochloride, USP is a white or almost white crystalline powder that is freely soluble in water, sparingly soluble in alcohol, practically insoluble in ether. The 2 mg, 4 mg, and 8 mg tablets contain the following inactive ingredients: lactose anhydrous, microcrystalline cellulose and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may also contain traces of sodium metabisulfite. The 2 mg tablets also contain D&C red #30 Lake dye, and D&C yellow #10. The 4 mg tablets also contain D&C yellow #10."
    },
    {
      "NDCCode": "43602-003-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (43602-003-05) ",
      "NDC11Code": "43602-0003-05",
      "ProductNDC": "43602-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210506",
      "LabelerName": "Ascent Pharmaceuticals Inc",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Hydromorphone Hydrochloride, USP, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone Hydrochloride Tablets, USP are supplied in 2 mg, 4 mg, and 8 mg tablets for oral administration. The tablet strengths describe the amount of Hydromorphone Hydrochloride in each tablet. The chemical name is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular Weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure. Hydromorphone Hydrochloride, USP is a white or almost white crystalline powder that is freely soluble in water, sparingly soluble in alcohol, practically insoluble in ether. The 2 mg, 4 mg, and 8 mg tablets contain the following inactive ingredients: lactose anhydrous, microcrystalline cellulose and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may also contain traces of sodium metabisulfite. The 2 mg tablets also contain D&C red #30 Lake dye, and D&C yellow #10. The 4 mg tablets also contain D&C yellow #10."
    },
    {
      "NDCCode": "43602-004-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (43602-004-05) ",
      "NDC11Code": "43602-0004-05",
      "ProductNDC": "43602-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210506",
      "LabelerName": "Ascent Pharmaceuticals Inc",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Hydromorphone Hydrochloride, USP, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone Hydrochloride Tablets, USP are supplied in 2 mg, 4 mg, and 8 mg tablets for oral administration. The tablet strengths describe the amount of Hydromorphone Hydrochloride in each tablet. The chemical name is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular Weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure. Hydromorphone Hydrochloride, USP is a white or almost white crystalline powder that is freely soluble in water, sparingly soluble in alcohol, practically insoluble in ether. The 2 mg, 4 mg, and 8 mg tablets contain the following inactive ingredients: lactose anhydrous, microcrystalline cellulose and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may also contain traces of sodium metabisulfite. The 2 mg tablets also contain D&C red #30 Lake dye, and D&C yellow #10. The 4 mg tablets also contain D&C yellow #10."
    },
    {
      "NDCCode": "43602-176-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (43602-176-05)  / 500 CAPSULE in 1 BOTTLE",
      "NDC11Code": "43602-0176-05",
      "ProductNDC": "43602-176",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bexarotene",
      "NonProprietaryName": "Bexarotene",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240906",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208628",
      "LabelerName": "Ascent pharmaceutical Inc",
      "SubstanceName": "BEXAROTENE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240906",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.",
      "Description": "Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, polyethylene glycol 400, polysorbate 20 and povidone. The capsule shell contains gelatin, glycerin, sorbitol sorbitan solution and opatint white. The opacode WB black ink contains ferrosoferric oxide, hypromellose, and propylene glycol. The composition of opatint white contain titanium dioxide."
    },
    {
      "NDCCode": "43602-177-05",
      "PackageDescription": "500 mL in 1 BOTTLE (43602-177-05) ",
      "NDC11Code": "43602-0177-05",
      "ProductNDC": "43602-177",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207417",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "METHYLPHENIDATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2021-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210129",
      "SamplePackage": "N",
      "IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
      "Description": "Methylphenidate hydrochloride oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white to off white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, polyethylene glycol, grape flavor and purified water."
    },
    {
      "NDCCode": "43602-178-05",
      "PackageDescription": "500 mL in 1 BOTTLE (43602-178-05) ",
      "NDC11Code": "43602-0178-05",
      "ProductNDC": "43602-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207417",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "METHYLPHENIDATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2021-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210129",
      "SamplePackage": "N",
      "IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
      "Description": "Methylphenidate hydrochloride oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white to off white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: diluted hydrochloric acid, glycerin, polyethylene glycol, grape flavor and purified water."
    },
    {
      "NDCCode": "43602-266-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-266-05) ",
      "NDC11Code": "43602-0266-05",
      "ProductNDC": "43602-266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200924",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212133",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
      "Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
    },
    {
      "NDCCode": "43602-267-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-267-05) ",
      "NDC11Code": "43602-0267-05",
      "ProductNDC": "43602-267",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200924",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212133",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
      "Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
    },
    {
      "NDCCode": "43602-268-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-268-05) ",
      "NDC11Code": "43602-0268-05",
      "ProductNDC": "43602-268",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200924",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212133",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "16",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
      "Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
    },
    {
      "NDCCode": "43602-269-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-269-05) ",
      "NDC11Code": "43602-0269-05",
      "ProductNDC": "43602-269",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydromorphone Hydrochloride",
      "NonProprietaryName": "Hydromorphone Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200924",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212133",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
      "StrengthNumber": "32",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.",
      "Description": "Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide. The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol."
    },
    {
      "NDCCode": "43602-284-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-284-05) ",
      "NDC11Code": "43602-0284-05",
      "ProductNDC": "43602-284",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214422",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "1125",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201230",
      "SamplePackage": "N",
      "IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
      "Description": "Potassium Chloride Extended-Release Tablets, USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 750 mg of microencapsulated potassium chloride, equivalent to 10 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 15 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,125 mg of microencapsulated potassium chloride, equivalent to 15 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,500 mg of microencapsulated potassium chloride, equivalent to 20 mEq K of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended-Release Tablets, USP is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended-Release Tablets, USP is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended-Release Tablets, USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP. FDA approved sample preparation in the assay differs from USP test."
    },
    {
      "NDCCode": "43602-285-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-285-05) ",
      "NDC11Code": "43602-0285-05",
      "ProductNDC": "43602-285",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214422",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "1500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201230",
      "SamplePackage": "N",
      "IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
      "Description": "Potassium Chloride Extended-Release Tablets, USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 750 mg of microencapsulated potassium chloride, equivalent to 10 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 15 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,125 mg of microencapsulated potassium chloride, equivalent to 15 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride, USP containing 1,500 mg of microencapsulated potassium chloride, equivalent to 20 mEq K of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended-Release Tablets, USP is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended-Release Tablets, USP is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended-Release Tablets, USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP. FDA approved sample preparation in the assay differs from USP test."
    },
    {
      "NDCCode": "43602-291-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (43602-291-05) ",
      "NDC11Code": "43602-0291-05",
      "ProductNDC": "43602-291",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Icosapent Ethyl",
      "NonProprietaryName": "Icosapent Ethyl",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220902",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216811",
      "LabelerName": "Ascent Pharmaceuticals, Inc",
      "SubstanceName": "ICOSAPENT ETHYL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220902",
      "SamplePackage": "N",
      "IndicationAndUsage": "Icosapent ethyl capsules are indicated: 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
      "Description": "Icosapent ethyl capsules, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram liquid-filled clear, transparent soft gelatin capsules containing clear to light yellow colored solution for oral use. Each icosapent ethyl capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.50. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. Icosapent ethyl capsules also contain the following inactive ingredients: bloom gelatin, glycerin, alpha tocopherol, medium chain triglycerides, and lecithin. The capsules are imprinted with white imprinting ink containing titanium dioxide, propylene glycol, and hypromellose 2910."
    },
    {
      "NDCCode": "43602-294-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-294-05) ",
      "NDC11Code": "43602-0294-05",
      "ProductNDC": "43602-294",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paliperidone",
      "NonProprietaryName": "Paliperidone",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230823",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216174",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "PALIPERIDONE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230823",
      "SamplePackage": "N",
      "Description": "Paliperidone extended-release tablets contain paliperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.48. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (beige), 3 mg (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD & C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. Delivery System Components and Performance. Paliperidone extended-release tablets use osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components."
    },
    {
      "NDCCode": "43602-295-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-295-05) ",
      "NDC11Code": "43602-0295-05",
      "ProductNDC": "43602-295",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paliperidone",
      "NonProprietaryName": "Paliperidone",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230823",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216174",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "PALIPERIDONE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230823",
      "SamplePackage": "N",
      "Description": "Paliperidone extended-release tablets contain paliperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.48. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (beige), 3 mg (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD & C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. Delivery System Components and Performance. Paliperidone extended-release tablets use osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components."
    },
    {
      "NDCCode": "43602-296-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-296-05) ",
      "NDC11Code": "43602-0296-05",
      "ProductNDC": "43602-296",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paliperidone",
      "NonProprietaryName": "Paliperidone",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230823",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216174",
      "LabelerName": "Ascent Pharmaceuticals, Inc.",
      "SubstanceName": "PALIPERIDONE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230823",
      "SamplePackage": "N",
      "Description": "Paliperidone extended-release tablets contain paliperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.48. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (beige), 3 mg (pink), 6 mg (beige), and 9 mg (yellow) strengths. Paliperidone extended-release tablets utilize OROS® osmotic drug-release technology. Inactive ingredients are lactose monohydrate, sodium chloride, hydroxypropyl methyl cellulose, polyethylene oxides, stearic acid, FD & C Red No. 40, povidone, magnesium stearate, hydroxypropyl cellulose, cellulose acetate, polyethylene glycol, ferrosoferric oxide, propylene glycol, and titanium dioxide. The 1.5 mg and 6 mg strengths also contain iron oxide yellow and iron oxide red. The 3 mg strength also contain iron oxide red. The 9 mg strength also contain iron oxide yellow and polysorbate 80. Delivery System Components and Performance. Paliperidone extended-release tablets use osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"43602-283-05","ProprietaryName":"Potassium Chloride","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"43602-283-30","ProprietaryName":"Potassium Chloride","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"13107-283-05","ProprietaryName":"Clorazepate Dipotassium","NonProprietaryName":"Clorazepate Dipotassium"},{"NDCCode":"36800-283-05","ProprietaryName":"Headache Relief","NonProprietaryName":"Acetaminophen, Aspirin And Caffeine"},{"NDCCode":"50383-283-05","ProprietaryName":"Levofloxacin","NonProprietaryName":"Levofloxacin"},{"NDCCode":"59137-283-05","ProprietaryName":"Ixinity","NonProprietaryName":"Coagulation Factor Ix (recombinant)"},{"NDCCode":"59746-283-05","ProprietaryName":"Pantoprazole Sodium","NonProprietaryName":"Pantoprazole Sodium"},{"NDCCode":"68428-283-05","ProprietaryName":"Candida Albicans","NonProprietaryName":"Candida Albicans"},{"NDCCode":"72865-283-05","ProprietaryName":"Oxcarbazepine","NonProprietaryName":"Oxcarbazepine"},{"NDCCode":"77040-283-05","ProprietaryName":"Arropure 70f","NonProprietaryName":"Alcohol"},{"NDCCode":"82699-307-05","ProprietaryName":"Right Guard Xtreme Humidity Breaker Antiperspirant Cold Front Invisible Solid","NonProprietaryName":"Right Guard Xtreme Humidity Breaker Antiperspirant Cold Front Invisible Solid"},{"NDCCode":"83324-282-05","ProprietaryName":"Quality Choice Earwax Removal Kit Earwax Removal Aid And Bulb","NonProprietaryName":"Carbamide Peroxide"},{"NDCCode":"83324-283-05","ProprietaryName":"Quality Choice Earwax Removal Drops Earwax Removal Aid","NonProprietaryName":"Carbamide Peroxide"},{"NDCCode":"84756-283-05","ProprietaryName":"Trstay Hair Essential Oil","NonProprietaryName":"Trstay Hair Essential Oil"},{"NDCCode":"43602-002-05","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"43602-003-05","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"43602-004-05","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"43602-176-05","ProprietaryName":"Bexarotene","NonProprietaryName":"Bexarotene"},{"NDCCode":"43602-177-05","ProprietaryName":"Methylphenidate Hydrochloride","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"43602-178-05","ProprietaryName":"Methylphenidate Hydrochloride","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"43602-266-05","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"43602-267-05","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"43602-268-05","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"43602-269-05","ProprietaryName":"Hydromorphone Hydrochloride","NonProprietaryName":"Hydromorphone Hydrochloride"},{"NDCCode":"43602-284-05","ProprietaryName":"Potassium Chloride","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"43602-285-05","ProprietaryName":"Potassium Chloride","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"43602-291-05","ProprietaryName":"Icosapent Ethyl","NonProprietaryName":"Icosapent Ethyl"},{"NDCCode":"43602-294-05","ProprietaryName":"Paliperidone","NonProprietaryName":"Paliperidone"},{"NDCCode":"43602-295-05","ProprietaryName":"Paliperidone","NonProprietaryName":"Paliperidone"},{"NDCCode":"43602-296-05","ProprietaryName":"Paliperidone","NonProprietaryName":"Paliperidone"}]}
                    

<NDCList><NDC><NDCCode>43602-283-05</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>43602-283-30</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>13107-283-05</NDCCode><ProprietaryName>Clorazepate Dipotassium</ProprietaryName><NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName></NDC><NDC><NDCCode>36800-283-05</NDCCode><ProprietaryName>Headache Relief</ProprietaryName><NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>50383-283-05</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>59137-283-05</NDCCode><ProprietaryName>Ixinity</ProprietaryName><NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>59746-283-05</NDCCode><ProprietaryName>Pantoprazole Sodium</ProprietaryName><NonProprietaryName>Pantoprazole Sodium</NonProprietaryName></NDC><NDC><NDCCode>68428-283-05</NDCCode><ProprietaryName>Candida Albicans</ProprietaryName><NonProprietaryName>Candida Albicans</NonProprietaryName></NDC><NDC><NDCCode>72865-283-05</NDCCode><ProprietaryName>Oxcarbazepine</ProprietaryName><NonProprietaryName>Oxcarbazepine</NonProprietaryName></NDC><NDC><NDCCode>77040-283-05</NDCCode><ProprietaryName>Arropure 70f</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>82699-307-05</NDCCode><ProprietaryName>Right Guard Xtreme Humidity Breaker Antiperspirant Cold Front Invisible Solid</ProprietaryName><NonProprietaryName>Right Guard Xtreme Humidity Breaker Antiperspirant Cold Front Invisible Solid</NonProprietaryName></NDC><NDC><NDCCode>83324-282-05</NDCCode><ProprietaryName>Quality Choice Earwax Removal Kit Earwax Removal Aid And Bulb</ProprietaryName><NonProprietaryName>Carbamide Peroxide</NonProprietaryName></NDC><NDC><NDCCode>83324-283-05</NDCCode><ProprietaryName>Quality Choice Earwax Removal Drops Earwax Removal Aid</ProprietaryName><NonProprietaryName>Carbamide Peroxide</NonProprietaryName></NDC><NDC><NDCCode>84756-283-05</NDCCode><ProprietaryName>Trstay Hair Essential Oil</ProprietaryName><NonProprietaryName>Trstay Hair Essential Oil</NonProprietaryName></NDC><NDC><NDCCode>43602-002-05</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-003-05</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-004-05</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-176-05</NDCCode><ProprietaryName>Bexarotene</ProprietaryName><NonProprietaryName>Bexarotene</NonProprietaryName></NDC><NDC><NDCCode>43602-177-05</NDCCode><ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-178-05</NDCCode><ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-266-05</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-267-05</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-268-05</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-269-05</NDCCode><ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName><NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43602-284-05</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>43602-285-05</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>43602-291-05</NDCCode><ProprietaryName>Icosapent Ethyl</ProprietaryName><NonProprietaryName>Icosapent Ethyl</NonProprietaryName></NDC><NDC><NDCCode>43602-294-05</NDCCode><ProprietaryName>Paliperidone</ProprietaryName><NonProprietaryName>Paliperidone</NonProprietaryName></NDC><NDC><NDCCode>43602-295-05</NDCCode><ProprietaryName>Paliperidone</ProprietaryName><NonProprietaryName>Paliperidone</NonProprietaryName></NDC><NDC><NDCCode>43602-296-05</NDCCode><ProprietaryName>Paliperidone</ProprietaryName><NonProprietaryName>Paliperidone</NonProprietaryName></NDC></NDCList>