RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "0126-0289-92",
      "PackageDescription": "100 mL in 1 BOTTLE (0126-0289-92) ",
      "NDC11Code": "00126-0289-92",
      "ProductNDC": "0126-0289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident Orthodefense",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20190304",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190307",
      "SamplePackage": "N",
      "IndicationAndUsage": "A dental caries preventive; for twice daily self-applied topical use. PreviDent® 5000 Ortho Defense 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).",
      "Description": "Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients."
    },
    {
      "NDCCode": "67544-289-92",
      "PackageDescription": "270 TABLET in 1 BOTTLE, PLASTIC (67544-289-92) ",
      "NDC11Code": "67544-0289-92",
      "ProductNDC": "67544-289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonazepam",
      "NonProprietaryName": "Clonazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090213",
      "EndMarketingDate": "20200630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074869",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "CLONAZEPAM",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20091114",
      "EndMarketingDatePackage": "20200630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Seizure Disorders: Clonazepam tablets, USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLlNICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
      "Description": "Clonazepam, USP a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
    },
    {
      "NDCCode": "71610-289-92",
      "PackageDescription": "270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-92) ",
      "NDC11Code": "71610-0289-92",
      "ProductNDC": "71610-289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Divalproex Sodium",
      "NonProprietaryName": "Divalproex Sodium",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140602",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202419",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "DIVALPROEX SODIUM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240903",
      "SamplePackage": "N",
      "IndicationAndUsage": "Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
      "Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis (2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients: FD&C Blue #1, FD&C Blue #2, hypromellose, mannitol, polyacrylate dispersion 40 percent, polyethylene glycol, pregelatinised starch (maize), propylene glycol, shellac glaze in ethanol, silicified microcrystalline cellulose, silicon dioxide, titanium dioxide, and triacetin. In addition, 500 mg tablets contain iron oxide black, iron oxide yellow, and polydextrose. Meets USP dissolution test 7."
    },
    {
      "NDCCode": "0126-0022-92",
      "PackageDescription": "100 mL in 1 BOTTLE (0126-0022-92) ",
      "NDC11Code": "00126-0022-92",
      "ProductNDC": "0126-0022",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident 5000 Enamel Protect",
      "NonProprietaryName": "Sodium Fluoride And Potassium Nitrate",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20110330",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "SODIUM FLUORIDE; POTASSIUM NITRATE",
      "StrengthNumber": "5.8; 57.5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110330",
      "SamplePackage": "N",
      "IndicationAndUsage": "A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).",
      "Description": "Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate."
    },
    {
      "NDCCode": "0126-0072-92",
      "PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (0126-0072-92) ",
      "NDC11Code": "00126-0072-92",
      "ProductNDC": "0126-0072",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident 5000 Booster Plus Fruitastic",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20150301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150301",
      "SamplePackage": "N",
      "IndicationAndUsage": "A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).",
      "Description": "Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients."
    },
    {
      "NDCCode": "0126-0074-92",
      "PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (0126-0074-92) ",
      "NDC11Code": "00126-0074-92",
      "ProductNDC": "0126-0074",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident 5000 Booster Plus Spearmint",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20150301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150301",
      "SamplePackage": "N",
      "IndicationAndUsage": "A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Prevident® 5000 BoosterPlus 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).",
      "Description": "Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients."
    },
    {
      "NDCCode": "0126-0075-92",
      "PackageDescription": "100 mL in 1 BOTTLE (0126-0075-92)",
      "NDC11Code": "00126-0075-92",
      "ProductNDC": "0126-0075",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident",
      "ProprietaryNameSuffix": "5000 Booster",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20090706",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate-Palmolive Company",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "13.4",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0076-92",
      "PackageDescription": "100 mL in 1 BOTTLE (0126-0076-92)",
      "NDC11Code": "00126-0076-92",
      "ProductNDC": "0126-0076",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident",
      "ProprietaryNameSuffix": "5000 Booster",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20090706",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate-Palmolive Company",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "13.4",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0311-92",
      "PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (0126-0311-92) ",
      "NDC11Code": "00126-0311-92",
      "ProductNDC": "0126-0311",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prevident 5000 Kids",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20230701",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230701",
      "SamplePackage": "N",
      "IndicationAndUsage": "A dental caries preventive; for once daily self-applied topical use. PreviDent® 5000 Kids brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).",
      "Description": "Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients."
    },
    {
      "NDCCode": "53157-126-92",
      "PackageDescription": "6 POUCH in 1 BOX (53157-126-92)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "53157-0126-92",
      "ProductNDC": "53157-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Wb System - Cp2d",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151007",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "Haemonetics Manufacturing Inc",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20151007",
      "SamplePackage": "N",
      "IndicationAndUsage": "For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.",
      "Description": "CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter and Sampling System. Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex."
    },
    {
      "NDCCode": "55718-126-92",
      "PackageDescription": "5 BAG in 1 CARTON (55718-126-92)  > 2000 mL in 1 BAG",
      "NDC11Code": "55718-0126-92",
      "ProductNDC": "55718-126",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "19920819",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Isomedix Operations Inc.",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
      "StrengthNumber": "1.5; 538; 448; 18.4; 5.08",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "70700-126-92",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (70700-126-92)  > 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "70700-0126-92",
      "ProductNDC": "70700-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Nitroprusside",
      "NonProprietaryName": "Sodium Nitroprusside Injection",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211277",
      "LabelerName": "Xiromed, LLC.",
      "SubstanceName": "SODIUM NITROPRUSSIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.",
      "Description": "Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside. whose molecular formula is Na2[Fe(CN)5NO]  2H2O, and whose molecular weight is 297.95. Dry sodium nitroprusside is a reddish-brown crystals or powder, freely soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium Nitroprusside Injection is available as:. 50 mg Fliptop Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in water for injection."
    },
    {
      "NDCCode": "71610-126-92",
      "PackageDescription": "270 CAPSULE in 1 BOTTLE (71610-126-92) ",
      "NDC11Code": "71610-0126-92",
      "ProductNDC": "71610-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078787",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2018-09-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180822",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
      "Description": "The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "0054-0289-13",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-13) ",
      "NDC11Code": "00054-0289-13",
      "ProductNDC": "0054-0289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Montelukast Sodium",
      "NonProprietaryName": "Montelukast Sodium",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091128",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "MONTELUKAST SODIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20120803",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0054-0289-22",
      "PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-22) ",
      "NDC11Code": "00054-0289-22",
      "ProductNDC": "0054-0289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Montelukast Sodium",
      "NonProprietaryName": "Montelukast Sodium",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091128",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "MONTELUKAST SODIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20120803",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0113-0289-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0113-0289-05)  > 15 mL in 1 BOTTLE",
      "NDC11Code": "00113-0289-05",
      "ProductNDC": "0113-0289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Sense Pain Relief",
      "ProprietaryNameSuffix": "Infants Concentrated",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "19931116",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "L Perrigo Company",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/.8mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-16"
    },
    {
      "NDCCode": "0220-0289-41",
      "PackageDescription": "30 [hp_C] in 1 TUBE (0220-0289-41) ",
      "NDC11Code": "00220-0289-41",
      "ProductNDC": "0220-0289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anacardium Orientale",
      "NonProprietaryName": "Semecarpus Anacardium Juice",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19830303",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Boiron",
      "SubstanceName": "SEMECARPUS ANACARDIUM JUICE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/30[hp_C]",
      "Status": "Active",
      "LastUpdate": "2023-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19830303",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indigestion from overeating*."
    },
    {
      "NDCCode": "0268-0289-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0289-10) ",
      "NDC11Code": "00268-0289-10",
      "ProductNDC": "0268-0289",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Rye Grass, Perennial Standardized",
      "NonProprietaryName": "Rye Grass, Perennial Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103056",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0268-0289-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0289-50) ",
      "NDC11Code": "00268-0289-50",
      "ProductNDC": "0268-0289",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Rye Grass, Perennial Standardized",
      "NonProprietaryName": "Rye Grass, Perennial Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103056",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0338-0289-47",
      "PackageDescription": "3000 mL in 1 BAG (0338-0289-47) ",
      "NDC11Code": "00338-0289-47",
      "ProductNDC": "0338-0289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glycine",
      "NonProprietaryName": "Glycine",
      "DosageFormName": "SOLUTION",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "19800530",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017865",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "GLYCINE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19800530",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.5% Glycine Irrigation, USP is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.",
      "Description": "1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, nonhemolytic, nonelectrolytic or very weakly ionized solution in single dose UROMATIC containers for use as a urologic irrigating solution. Each liter contains 15 g Glycine, USP (NH2CH2COOH) in water for injection. pH 6.0 (4.5 to 6.5). Osmolarity 200 mOsmol/L (calc.). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. No antimicrobial agent has been added. The UROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-0289-49",
      "PackageDescription": "5000 mL in 1 BAG (0338-0289-49)",
      "NDC11Code": "00338-0289-49",
      "ProductNDC": "0338-0289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glycine",
      "NonProprietaryName": "Glycine",
      "DosageFormName": "IRRIGANT",
      "RouteName": "IRRIGATION",
      "StartMarketingDate": "19800530",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017865",
      "LabelerName": "BAXTER HEALTHCARE CORPORATION",
      "SubstanceName": "GLYCINE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-10-03"
    },
    {
      "NDCCode": "0363-0289-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0363-0289-05)  > 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00363-0289-05",
      "ProductNDC": "0363-0289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pain Reliever",
      "ProprietaryNameSuffix": "Infants",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930803",
      "EndMarketingDate": "20150814",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Walgreen Company",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/.8mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-08-21"
    },
    {
      "NDCCode": "0363-0289-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0363-0289-10)  > 30 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00363-0289-10",
      "ProductNDC": "0363-0289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pain Reliever",
      "ProprietaryNameSuffix": "Infants",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930803",
      "EndMarketingDate": "20150814",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Walgreen Company",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/.8mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-08-21"
    },
    {
      "NDCCode": "10096-0289-1",
      "PackageDescription": "250 mL in 1 BOTTLE (10096-0289-1)",
      "NDC11Code": "10096-0289-01",
      "ProductNDC": "10096-0289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clearskin Pore Penetrating",
      "ProprietaryNameSuffix": "Cooling Toner",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121106",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Avon Products, Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses for the treatment of acne penetrates pores to help control acne blemishes."
    },
    {
      "NDCCode": "10544-289-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-289-30)",
      "NDC11Code": "10544-0289-30",
      "ProductNDC": "10544-289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Terazosin",
      "NonProprietaryName": "Terazosin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075498",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "TERAZOSIN HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Terazosin Capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with Terazosin Capsules, USP. The long-term effects of Terazosin Capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin Capsules, USP are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
      "Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Terazosin Capsules, USP for oral ingestion are supplied in four dosage strengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin."
    },
    {
      "NDCCode": "10544-289-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (10544-289-90)",
      "NDC11Code": "10544-0289-90",
      "ProductNDC": "10544-289",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Terazosin",
      "NonProprietaryName": "Terazosin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075498",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "TERAZOSIN HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Terazosin Capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with Terazosin Capsules, USP. The long-term effects of Terazosin Capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin Capsules, USP are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
      "Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Terazosin Capsules, USP for oral ingestion are supplied in four dosage strengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin."
    },
    {
      "NDCCode": "11673-289-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (11673-289-05)  > 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "11673-0289-05",
      "ProductNDC": "11673-289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Infants Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090612",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Target Corporation",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/.8mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-16"
    },
    {
      "NDCCode": "11673-289-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (11673-289-10)  > 30 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "11673-0289-10",
      "ProductNDC": "11673-289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Infants Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090612",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Target Corporation",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/.8mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-06-16"
    },
    {
      "NDCCode": "13537-289-26",
      "PackageDescription": "1 TUBE in 1 BOX (13537-289-26)  > 4 g in 1 TUBE (13537-289-25)",
      "NDC11Code": "13537-0289-26",
      "ProductNDC": "13537-289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esika Extreme Moisturizing Spf 16",
      "ProprietaryNameSuffix": "(rojo Lujuria) - Red",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131216",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": ".066; .015",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "13630-0289-4",
      "PackageDescription": "155 g in 1 CAN (13630-0289-4) ",
      "NDC11Code": "13630-0289-04",
      "ProductNDC": "13630-0289",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Instanatural",
      "ProprietaryNameSuffix": "Broad Spectrum Spf 50",
      "NonProprietaryName": "Octisalate, Octocrylene, Homosalate, Avobenzone",
      "DosageFormName": "AEROSOL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240731",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Prime Packaging",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": ".03; .1; .05; .05",
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      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240731",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    }
  ]
}
                    

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  <NDC>
    <NDCCode>0126-0289-92</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (0126-0289-92) </PackageDescription>
    <NDC11Code>00126-0289-92</NDC11Code>
    <ProductNDC>0126-0289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevident Orthodefense</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20190304</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A dental caries preventive; for twice daily self-applied topical use. PreviDent® 5000 Ortho Defense 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).</IndicationAndUsage>
    <Description>Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.</Description>
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  <NDC>
    <NDCCode>67544-289-92</NDCCode>
    <PackageDescription>270 TABLET in 1 BOTTLE, PLASTIC (67544-289-92) </PackageDescription>
    <NDC11Code>67544-0289-92</NDC11Code>
    <ProductNDC>67544-289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonazepam</ProprietaryName>
    <NonProprietaryName>Clonazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090213</StartMarketingDate>
    <EndMarketingDate>20200630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074869</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>CLONAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20091114</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Seizure Disorders: Clonazepam tablets, USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLlNICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Clonazepam, USP a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&amp;C Red #30 aluminum lake. The 1 mg tablet also contains D&amp;C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
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    <NDCCode>71610-289-92</NDCCode>
    <PackageDescription>270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-92) </PackageDescription>
    <NDC11Code>71610-0289-92</NDC11Code>
    <ProductNDC>71610-289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Divalproex Sodium</ProprietaryName>
    <NonProprietaryName>Divalproex Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202419</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>DIVALPROEX SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240903</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
    <Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis (2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients: FD&amp;C Blue #1, FD&amp;C Blue #2, hypromellose, mannitol, polyacrylate dispersion 40 percent, polyethylene glycol, pregelatinised starch (maize), propylene glycol, shellac glaze in ethanol, silicified microcrystalline cellulose, silicon dioxide, titanium dioxide, and triacetin. In addition, 500 mg tablets contain iron oxide black, iron oxide yellow, and polydextrose. Meets USP dissolution test 7.</Description>
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  <NDC>
    <NDCCode>0126-0022-92</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (0126-0022-92) </PackageDescription>
    <NDC11Code>00126-0022-92</NDC11Code>
    <ProductNDC>0126-0022</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevident 5000 Enamel Protect</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride And Potassium Nitrate</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20110330</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE; POTASSIUM NITRATE</SubstanceName>
    <StrengthNumber>5.8; 57.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).</IndicationAndUsage>
    <Description>Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.</Description>
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    <NDCCode>0126-0072-92</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, PLASTIC (0126-0072-92) </PackageDescription>
    <NDC11Code>00126-0072-92</NDC11Code>
    <ProductNDC>0126-0072</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevident 5000 Booster Plus Fruitastic</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).</IndicationAndUsage>
    <Description>Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.</Description>
  </NDC>
  <NDC>
    <NDCCode>0126-0074-92</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, PLASTIC (0126-0074-92) </PackageDescription>
    <NDC11Code>00126-0074-92</NDC11Code>
    <ProductNDC>0126-0074</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevident 5000 Booster Plus Spearmint</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20150301</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Prevident® 5000 BoosterPlus 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).</IndicationAndUsage>
    <Description>Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.</Description>
  </NDC>
  <NDC>
    <NDCCode>0126-0075-92</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (0126-0075-92)</PackageDescription>
    <NDC11Code>00126-0075-92</NDC11Code>
    <ProductNDC>0126-0075</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevident</ProprietaryName>
    <ProprietaryNameSuffix>5000 Booster</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20090706</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Colgate-Palmolive Company</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>13.4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
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    <NDCCode>0126-0076-92</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (0126-0076-92)</PackageDescription>
    <NDC11Code>00126-0076-92</NDC11Code>
    <ProductNDC>0126-0076</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevident</ProprietaryName>
    <ProprietaryNameSuffix>5000 Booster</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20090706</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Colgate-Palmolive Company</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>13.4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0126-0311-92</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, PLASTIC (0126-0311-92) </PackageDescription>
    <NDC11Code>00126-0311-92</NDC11Code>
    <ProductNDC>0126-0311</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prevident 5000 Kids</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20230701</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A dental caries preventive; for once daily self-applied topical use. PreviDent® 5000 Kids brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.).</IndicationAndUsage>
    <Description>Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.</Description>
  </NDC>
  <NDC>
    <NDCCode>53157-126-92</NDCCode>
    <PackageDescription>6 POUCH in 1 BOX (53157-126-92)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG</PackageDescription>
    <NDC11Code>53157-0126-92</NDC11Code>
    <ProductNDC>53157-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leukotrap Wb System - Cp2d</ProprietaryName>
    <NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151007</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN820915</ApplicationNumber>
    <LabelerName>Haemonetics Manufacturing Inc</LabelerName>
    <SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>3.57</StrengthNumber>
    <StrengthUnit>g/70mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.</IndicationAndUsage>
    <Description>CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter and Sampling System. Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex.</Description>
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    <NDCCode>55718-126-92</NDCCode>
    <PackageDescription>5 BAG in 1 CARTON (55718-126-92)  &gt; 2000 mL in 1 BAG</PackageDescription>
    <NDC11Code>55718-0126-92</NDC11Code>
    <ProductNDC>55718-126</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>19920819</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Isomedix Operations Inc.</LabelerName>
    <SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.5; 538; 448; 18.4; 5.08</StrengthNumber>
    <StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70700-126-92</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (70700-126-92)  &gt; 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>70700-0126-92</NDC11Code>
    <ProductNDC>70700-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Nitroprusside</ProprietaryName>
    <NonProprietaryName>Sodium Nitroprusside Injection</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211277</ApplicationNumber>
    <LabelerName>Xiromed, LLC.</LabelerName>
    <SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.</IndicationAndUsage>
    <Description>Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside. whose molecular formula is Na2[Fe(CN)5NO]  2H2O, and whose molecular weight is 297.95. Dry sodium nitroprusside is a reddish-brown crystals or powder, freely soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium Nitroprusside Injection is available as:. 50 mg Fliptop Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-126-92</NDCCode>
    <PackageDescription>270 CAPSULE in 1 BOTTLE (71610-126-92) </PackageDescription>
    <NDC11Code>71610-0126-92</NDC11Code>
    <ProductNDC>71610-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078787</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2018-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0289-13</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-13) </PackageDescription>
    <NDC11Code>00054-0289-13</NDC11Code>
    <ProductNDC>0054-0289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120803</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091128</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120803</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0054-0289-22</NDCCode>
    <PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-22) </PackageDescription>
    <NDC11Code>00054-0289-22</NDC11Code>
    <ProductNDC>0054-0289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120803</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091128</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120803</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0113-0289-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0113-0289-05)  &gt; 15 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00113-0289-05</NDC11Code>
    <ProductNDC>0113-0289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Good Sense Pain Relief</ProprietaryName>
    <ProprietaryNameSuffix>Infants Concentrated</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19931116</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>L Perrigo Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-16</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0220-0289-41</NDCCode>
    <PackageDescription>30 [hp_C] in 1 TUBE (0220-0289-41) </PackageDescription>
    <NDC11Code>00220-0289-41</NDC11Code>
    <ProductNDC>0220-0289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anacardium Orientale</ProprietaryName>
    <NonProprietaryName>Semecarpus Anacardium Juice</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19830303</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Boiron</LabelerName>
    <SubstanceName>SEMECARPUS ANACARDIUM JUICE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/30[hp_C]</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19830303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indigestion from overeating*.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0268-0289-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0289-10) </PackageDescription>
    <NDC11Code>00268-0289-10</NDC11Code>
    <ProductNDC>0268-0289</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Rye Grass, Perennial Standardized</ProprietaryName>
    <NonProprietaryName>Rye Grass, Perennial Standardized</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19971218</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103056</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>LOLIUM PERENNE POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.</IndicationAndUsage>
    <Description>Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method.</Description>
  </NDC>
  <NDC>
    <NDCCode>0268-0289-50</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0289-50) </PackageDescription>
    <NDC11Code>00268-0289-50</NDC11Code>
    <ProductNDC>0268-0289</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Rye Grass, Perennial Standardized</ProprietaryName>
    <NonProprietaryName>Rye Grass, Perennial Standardized</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19971218</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103056</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>LOLIUM PERENNE POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-05-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.</IndicationAndUsage>
    <Description>Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0289-47</NDCCode>
    <PackageDescription>3000 mL in 1 BAG (0338-0289-47) </PackageDescription>
    <NDC11Code>00338-0289-47</NDC11Code>
    <ProductNDC>0338-0289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycine</ProprietaryName>
    <NonProprietaryName>Glycine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19800530</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017865</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>GLYCINE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-02-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19800530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.5% Glycine Irrigation, USP is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.</IndicationAndUsage>
    <Description>1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, nonhemolytic, nonelectrolytic or very weakly ionized solution in single dose UROMATIC containers for use as a urologic irrigating solution. Each liter contains 15 g Glycine, USP (NH2CH2COOH) in water for injection. pH 6.0 (4.5 to 6.5). Osmolarity 200 mOsmol/L (calc.). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. No antimicrobial agent has been added. The UROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-0289-49</NDCCode>
    <PackageDescription>5000 mL in 1 BAG (0338-0289-49)</PackageDescription>
    <NDC11Code>00338-0289-49</NDC11Code>
    <ProductNDC>0338-0289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycine</ProprietaryName>
    <NonProprietaryName>Glycine</NonProprietaryName>
    <DosageFormName>IRRIGANT</DosageFormName>
    <RouteName>IRRIGATION</RouteName>
    <StartMarketingDate>19800530</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017865</ApplicationNumber>
    <LabelerName>BAXTER HEALTHCARE CORPORATION</LabelerName>
    <SubstanceName>GLYCINE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-10-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0363-0289-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0363-0289-05)  &gt; 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00363-0289-05</NDC11Code>
    <ProductNDC>0363-0289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Reliever</ProprietaryName>
    <ProprietaryNameSuffix>Infants</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930803</StartMarketingDate>
    <EndMarketingDate>20150814</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Walgreen Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-08-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0363-0289-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0363-0289-10)  &gt; 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00363-0289-10</NDC11Code>
    <ProductNDC>0363-0289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Reliever</ProprietaryName>
    <ProprietaryNameSuffix>Infants</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19930803</StartMarketingDate>
    <EndMarketingDate>20150814</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Walgreen Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-08-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10096-0289-1</NDCCode>
    <PackageDescription>250 mL in 1 BOTTLE (10096-0289-1)</PackageDescription>
    <NDC11Code>10096-0289-01</NDC11Code>
    <ProductNDC>10096-0289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clearskin Pore Penetrating</ProprietaryName>
    <ProprietaryNameSuffix>Cooling Toner</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20121106</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>Avon Products, Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses for the treatment of acne penetrates pores to help control acne blemishes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10544-289-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (10544-289-30)</PackageDescription>
    <NDC11Code>10544-0289-30</NDC11Code>
    <ProductNDC>10544-289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Terazosin</ProprietaryName>
    <NonProprietaryName>Terazosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075498</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Terazosin Capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with Terazosin Capsules, USP. The long-term effects of Terazosin Capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin Capsules, USP are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Terazosin Capsules, USP for oral ingestion are supplied in four dosage strengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-289-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (10544-289-90)</PackageDescription>
    <NDC11Code>10544-0289-90</NDC11Code>
    <ProductNDC>10544-289</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Terazosin</ProprietaryName>
    <NonProprietaryName>Terazosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075498</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Terazosin Capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with Terazosin Capsules, USP. The long-term effects of Terazosin Capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin Capsules, USP are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Terazosin Capsules, USP for oral ingestion are supplied in four dosage strengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin.</Description>
  </NDC>
  <NDC>
    <NDCCode>11673-289-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (11673-289-05)  &gt; 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>11673-0289-05</NDC11Code>
    <ProductNDC>11673-289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Infants Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090612</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-16</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11673-289-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (11673-289-10)  &gt; 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>11673-0289-10</NDC11Code>
    <ProductNDC>11673-289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Infants Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090612</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-06-16</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>13537-289-26</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (13537-289-26)  &gt; 4 g in 1 TUBE (13537-289-25)</PackageDescription>
    <NDC11Code>13537-0289-26</NDC11Code>
    <ProductNDC>13537-289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esika Extreme Moisturizing Spf 16</ProprietaryName>
    <ProprietaryNameSuffix>(rojo Lujuria) - Red</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura Corporation LTD</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>.066; .015</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13630-0289-4</NDCCode>
    <PackageDescription>155 g in 1 CAN (13630-0289-4) </PackageDescription>
    <NDC11Code>13630-0289-04</NDC11Code>
    <ProductNDC>13630-0289</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instanatural</ProprietaryName>
    <ProprietaryNameSuffix>Broad Spectrum Spf 50</ProprietaryNameSuffix>
    <NonProprietaryName>Octisalate, Octocrylene, Homosalate, Avobenzone</NonProprietaryName>
    <DosageFormName>AEROSOL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240731</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Prime Packaging</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>.03; .1; .05; .05</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0126-0289-92</NDCCode><ProprietaryName>Prevident Orthodefense</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>67544-289-92</NDCCode><ProprietaryName>Clonazepam</ProprietaryName><NonProprietaryName>Clonazepam</NonProprietaryName></NDC><NDC><NDCCode>71610-289-92</NDCCode><ProprietaryName>Divalproex Sodium</ProprietaryName><NonProprietaryName>Divalproex Sodium</NonProprietaryName></NDC><NDC><NDCCode>0126-0022-92</NDCCode><ProprietaryName>Prevident 5000 Enamel Protect</ProprietaryName><NonProprietaryName>Sodium Fluoride And Potassium Nitrate</NonProprietaryName></NDC><NDC><NDCCode>0126-0072-92</NDCCode><ProprietaryName>Prevident 5000 Booster Plus Fruitastic</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0126-0074-92</NDCCode><ProprietaryName>Prevident 5000 Booster Plus Spearmint</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0126-0075-92</NDCCode><ProprietaryName>Prevident</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0126-0076-92</NDCCode><ProprietaryName>Prevident</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0126-0311-92</NDCCode><ProprietaryName>Prevident 5000 Kids</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>53157-126-92</NDCCode><ProprietaryName>Leukotrap Wb System - Cp2d</ProprietaryName><NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName></NDC><NDC><NDCCode>55718-126-92</NDCCode><NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName></NDC><NDC><NDCCode>70700-126-92</NDCCode><ProprietaryName>Sodium Nitroprusside</ProprietaryName><NonProprietaryName>Sodium Nitroprusside Injection</NonProprietaryName></NDC><NDC><NDCCode>71610-126-92</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>0054-0289-13</NDCCode><ProprietaryName>Montelukast Sodium</ProprietaryName><NonProprietaryName>Montelukast Sodium</NonProprietaryName></NDC><NDC><NDCCode>0054-0289-22</NDCCode><ProprietaryName>Montelukast Sodium</ProprietaryName><NonProprietaryName>Montelukast Sodium</NonProprietaryName></NDC><NDC><NDCCode>0113-0289-05</NDCCode><ProprietaryName>Good Sense Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0220-0289-41</NDCCode><ProprietaryName>Anacardium Orientale</ProprietaryName><NonProprietaryName>Semecarpus Anacardium Juice</NonProprietaryName></NDC><NDC><NDCCode>0268-0289-10</NDCCode><ProprietaryName>Rye Grass, Perennial Standardized</ProprietaryName><NonProprietaryName>Rye Grass, Perennial Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0289-50</NDCCode><ProprietaryName>Rye Grass, Perennial Standardized</ProprietaryName><NonProprietaryName>Rye Grass, Perennial Standardized</NonProprietaryName></NDC><NDC><NDCCode>0338-0289-47</NDCCode><ProprietaryName>Glycine</ProprietaryName><NonProprietaryName>Glycine</NonProprietaryName></NDC><NDC><NDCCode>0338-0289-49</NDCCode><ProprietaryName>Glycine</ProprietaryName><NonProprietaryName>Glycine</NonProprietaryName></NDC><NDC><NDCCode>0363-0289-05</NDCCode><ProprietaryName>Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0363-0289-10</NDCCode><ProprietaryName>Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>10096-0289-1</NDCCode><ProprietaryName>Clearskin Pore Penetrating</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>10544-289-30</NDCCode><ProprietaryName>Terazosin</ProprietaryName><NonProprietaryName>Terazosin</NonProprietaryName></NDC><NDC><NDCCode>10544-289-90</NDCCode><ProprietaryName>Terazosin</ProprietaryName><NonProprietaryName>Terazosin</NonProprietaryName></NDC><NDC><NDCCode>11673-289-05</NDCCode><ProprietaryName>Up And Up Infants Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>11673-289-10</NDCCode><ProprietaryName>Up And Up Infants Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>13537-289-26</NDCCode><ProprietaryName>Esika Extreme Moisturizing Spf 16</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>13630-0289-4</NDCCode><ProprietaryName>Instanatural</ProprietaryName><NonProprietaryName>Octisalate, Octocrylene, Homosalate, Avobenzone</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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