RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "35356-867-90",
      "PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (35356-867-90)",
      "NDC11Code": "35356-0867-90",
      "ProductNDC": "35356-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960308",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020254",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-11",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35356-867-30",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (35356-867-30)",
      "NDC11Code": "35356-0867-30",
      "ProductNDC": "35356-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960308",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020254",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-11",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35356-867-60",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (35356-867-60)",
      "NDC11Code": "35356-0867-60",
      "ProductNDC": "35356-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960308",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020254",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-11",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "16590-867-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (16590-867-90)",
      "NDC11Code": "16590-0867-90",
      "ProductNDC": "16590-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078858",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.",
      "Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.                          250 mg tablets: FD&C Blue # 2 Lake of indigo carmine.                          500 mg tablets: Ferric oxide yellow.                          750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow."
    },
    {
      "NDCCode": "21695-867-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (21695-867-90)",
      "NDC11Code": "21695-0867-90",
      "ProductNDC": "21695-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mirapex",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020667",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Mirapex® (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of MIRAPEX tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see CLINICAL STUDIES).",
      "Description": "MIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S  2HCl  H2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. MIRAPEX tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, cornstarch, colloidal silicon dioxide, povidone, and magnesium stearate."
    },
    {
      "NDCCode": "33261-867-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (33261-867-90)",
      "NDC11Code": "33261-0867-90",
      "ProductNDC": "33261-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pravastatin Sodium",
      "NonProprietaryName": "Pravastatin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100330",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077751",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "PRAVASTATIN SODIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Pravastatin sodium tablet is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1) , 2 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2) , 3 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2) , 4 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 5 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).",
      "Description": "Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous."
    },
    {
      "NDCCode": "43063-867-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-90) ",
      "NDC11Code": "43063-0867-90",
      "ProductNDC": "43063-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090796",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180711",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43353-867-60",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43353-867-60)",
      "NDC11Code": "43353-0867-60",
      "ProductNDC": "43353-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130618",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076262",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS,  Head and Neck Angioedema.).",
      "Description": "Lisinopril and hydrochlorothiazide combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2 and its structural formula is: [Enter image caption here]. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. Inactive ingredients are: calcium phosphate, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and starch. Lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg, and 20 mg/25 mg also contain iron oxides."
    },
    {
      "NDCCode": "45865-867-90",
      "PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-867-90) ",
      "NDC11Code": "45865-0867-90",
      "ProductNDC": "45865-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19980729",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075227",
      "LabelerName": "medsource pharmaceuticals",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen delayed-release tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis , 2 osteoarthritis , 3 ankylosing spondylitis , 4 Polyarticular Juvenile Idiopathic Arthritis .",
      "Description": "Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of non-steroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (+)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula. C 14H 14O 3 M.W. 230.26. Naproxen, USP is a practically odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. Naproxen Delayed-Release Tablets USP are available as enteric-coated, white to off-white tablets containing 375 mg or 500 mg of naproxen, USP for oral administration. The inactive ingredients are: antifoam DC 1510, corn starch, croscarmellose sodium, FD&C Blue # 2 Aluminum Lake, magnesium stearate, methacrylic acid copolymer-dispersion, povidone, propylene glycol, shellac, talc, titanium dioxide, and triethyl citrate. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4."
    },
    {
      "NDCCode": "60429-867-90",
      "PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-867-90) ",
      "NDC11Code": "60429-0867-90",
      "ProductNDC": "60429-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170324",
      "EndMarketingDate": "20241031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205468",
      "LabelerName": "Golden State Medical Supply",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "225",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170405",
      "EndMarketingDatePackage": "20241031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Venlafaxine hydrochloride extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) ( 1.1) , 2 Social Anxiety Disorder (SAD) (  1.2)  .",
      "Description": "Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is white to off-white crystalline solid with a solubility of 572 mg/ mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 sodium chloride) patition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets is comprised of a matrix system containing.hydrophilic polymers surrounded by an insoluble but permeable coat. After administaration, the soluble components of the coat dissolve and fluid from the gastrointestinal tract enters the tablet through the porous coat, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion and erosion of the polymeric matrix. Tablets contain venlafaxine hydrochloride, USP equivalent to 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, silicified microcrystalline cellulose, opadry, polyethylene glycol, surelease clear,talc, titanium dioxide, triacetin and xanthan gum."
    },
    {
      "NDCCode": "63187-867-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (63187-867-90) ",
      "NDC11Code": "63187-0867-90",
      "ProductNDC": "63187-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071135",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
      "Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1."
    },
    {
      "NDCCode": "68382-867-16",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (68382-867-16) ",
      "NDC11Code": "68382-0867-16",
      "ProductNDC": "68382-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206752",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20250214",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, colored powder with a pKa1 of 4.2 and a pKa2 of 10.6. 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 – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin. Each capsule contains following inactive ingredients: gelatin, pregelatinised starch, sodium lauryl sulfate, talc and titanium dioxide. Additionally, 50 mg capsules contain iron oxide yellow; 75 mg and 100 mg capsules contain FD & C Yellow 6, and FD & C Red 3; 150 mg capsules contain FD & C Yellow 6, and D & C Yellow 10; 200 mg and 225 mg capsules contain iron oxide red, and iron oxide yellow; and 300 mg capsules contain FD & C Blue 1, FD & C Yellow 6. The capsule body is imprinted with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "69842-867-90",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69842-867-90)  / 90 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "69842-0867-90",
      "ProductNDC": "69842-867",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Cetirizine Hydrochloride Tablets",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078343",
      "LabelerName": "CVS Health Corp.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20111201",
      "SamplePackage": "N",
      "IndicationAndUsage": ". temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat ."
    },
    {
      "NDCCode": "71205-867-90",
      "PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-90) ",
      "NDC11Code": "71205-0867-90",
      "ProductNDC": "71205-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranolazine",
      "NonProprietaryName": "Ranolazine",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210824",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211829",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "RANOLAZINE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-04-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211217",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
      "Description": "Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, hypromellose, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin, Iron Oxide Yellow, and Iron Oxide Red; additional inactive ingredients for the 1000 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin and Iron Oxide Yellow."
    },
    {
      "NDCCode": "71610-867-60",
      "PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60) ",
      "NDC11Code": "71610-0867-60",
      "ProductNDC": "71610-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207427",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24."
    },
    {
      "NDCCode": "84197-867-00",
      "PackageDescription": "90 mL in 1 BOTTLE (84197-867-00) ",
      "NDC11Code": "84197-0867-00",
      "ProductNDC": "84197-867",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Flexdermal Pain Relieving Roll-on",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250124",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "SOLVADERM LLC",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-02-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250124",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains."
    },
    {
      "NDCCode": "71610-867-53",
      "PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53) ",
      "NDC11Code": "71610-0867-53",
      "ProductNDC": "71610-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207427",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24."
    },
    {
      "NDCCode": "71610-867-70",
      "PackageDescription": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70) ",
      "NDC11Code": "71610-0867-70",
      "ProductNDC": "71610-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207427",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24."
    },
    {
      "NDCCode": "71610-867-80",
      "PackageDescription": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80) ",
      "NDC11Code": "71610-0867-80",
      "ProductNDC": "71610-867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207427",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24."
    },
    {
      "NDCCode": "35356-048-90",
      "PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35356-048-90)",
      "NDC11Code": "35356-0048-90",
      "ProductNDC": "35356-048",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kadian",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111221",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020616",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-22"
    },
    {
      "NDCCode": "35356-053-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (35356-053-90)",
      "NDC11Code": "35356-0053-90",
      "ProductNDC": "35356-053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyrica",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110718",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021724",
      "LabelerName": "Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "LYRICA is indicated for.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
    },
    {
      "NDCCode": "35356-054-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (35356-054-90) ",
      "NDC11Code": "35356-0054-90",
      "ProductNDC": "35356-054",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lyrica",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20041230",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021446",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20120206",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "35356-059-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (35356-059-90)",
      "NDC11Code": "35356-0059-90",
      "ProductNDC": "35356-059",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate",
      "NonProprietaryName": "Amlodipine Besylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078925",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "AMLODIPINE BESYLATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-27",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35356-091-90",
      "PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-091-90)",
      "NDC11Code": "35356-0091-90",
      "ProductNDC": "35356-091",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycontin",
      "NonProprietaryName": "Oxycodone Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110609",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020553",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-22"
    },
    {
      "NDCCode": "35356-101-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (35356-101-90)",
      "NDC11Code": "35356-0101-90",
      "ProductNDC": "35356-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diovan",
      "NonProprietaryName": "Valsartan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021283",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "VALSARTAN",
      "StrengthNumber": "320",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-19"
    },
    {
      "NDCCode": "35356-125-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (35356-125-90)",
      "NDC11Code": "35356-0125-90",
      "ProductNDC": "35356-125",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pravastatin Sodium",
      "NonProprietaryName": "Pravastatin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076341",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "PRAVASTATIN SODIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-24"
    },
    {
      "NDCCode": "35356-176-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (35356-176-90)",
      "NDC11Code": "35356-0176-90",
      "ProductNDC": "35356-176",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pentazocine And Naloxone",
      "NonProprietaryName": "Pentazocine Hydrochloride And Naloxone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970121",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074736",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
      "StrengthNumber": "50; .5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-26"
    },
    {
      "NDCCode": "35356-211-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (35356-211-90)",
      "NDC11Code": "35356-0211-90",
      "ProductNDC": "35356-211",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone Hydrochloride",
      "NonProprietaryName": "Oxycodone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077290",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35356-212-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (35356-212-90)",
      "NDC11Code": "35356-0212-90",
      "ProductNDC": "35356-212",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone Hydrochloride",
      "NonProprietaryName": "Oxycodone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077290",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "35356-216-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-216-90)",
      "NDC11Code": "35356-0216-90",
      "ProductNDC": "35356-216",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benicar",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120222",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021286",
      "LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-26"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"35356-867-90","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium"},{"NDCCode":"35356-867-30","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium"},{"NDCCode":"35356-867-60","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium"},{"NDCCode":"16590-867-90","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"21695-867-90","ProprietaryName":"Mirapex","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"33261-867-90","ProprietaryName":"Pravastatin Sodium","NonProprietaryName":"Pravastatin Sodium"},{"NDCCode":"43063-867-90","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"43353-867-60","ProprietaryName":"Lisinopril And Hydrochlorothiazide","NonProprietaryName":"Lisinopril And Hydrochlorothiazide"},{"NDCCode":"45865-867-90","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"60429-867-90","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"63187-867-90","ProprietaryName":"Diazepam","NonProprietaryName":"Diazepam"},{"NDCCode":"68382-867-16","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"69842-867-90","ProprietaryName":"Allergy Relief","NonProprietaryName":"Cetirizine Hydrochloride Tablets"},{"NDCCode":"71205-867-90","ProprietaryName":"Ranolazine","NonProprietaryName":"Ranolazine"},{"NDCCode":"71610-867-60","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"84197-867-00","ProprietaryName":"Flexdermal Pain Relieving Roll-on","NonProprietaryName":"Menthol"},{"NDCCode":"71610-867-53","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"71610-867-70","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"71610-867-80","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin Hydrochloride"},{"NDCCode":"35356-048-90","ProprietaryName":"Kadian","NonProprietaryName":"Morphine Sulfate"},{"NDCCode":"35356-053-90","ProprietaryName":"Lyrica","NonProprietaryName":"Pregabalin"},{"NDCCode":"35356-054-90","ProprietaryName":"Lyrica","NonProprietaryName":"Pregabalin"},{"NDCCode":"35356-059-90","ProprietaryName":"Amlodipine Besylate","NonProprietaryName":"Amlodipine Besylate"},{"NDCCode":"35356-091-90","ProprietaryName":"Oxycontin","NonProprietaryName":"Oxycodone Hydrochloride"},{"NDCCode":"35356-101-90","ProprietaryName":"Diovan","NonProprietaryName":"Valsartan"},{"NDCCode":"35356-125-90","ProprietaryName":"Pravastatin Sodium","NonProprietaryName":"Pravastatin Sodium"},{"NDCCode":"35356-176-90","ProprietaryName":"Pentazocine And Naloxone","NonProprietaryName":"Pentazocine Hydrochloride And Naloxone Hydrochloride"},{"NDCCode":"35356-211-90","ProprietaryName":"Oxycodone Hydrochloride","NonProprietaryName":"Oxycodone Hydrochloride"},{"NDCCode":"35356-212-90","ProprietaryName":"Oxycodone Hydrochloride","NonProprietaryName":"Oxycodone Hydrochloride"},{"NDCCode":"35356-216-90","ProprietaryName":"Benicar","NonProprietaryName":"Olmesartan Medoxomil"}]}
                    

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  <NDC>
    <NDCCode>35356-867-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (35356-867-90)</PackageDescription>
    <NDC11Code>35356-0867-90</NDC11Code>
    <ProductNDC>35356-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960308</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020254</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-11</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>35356-867-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (35356-867-30)</PackageDescription>
    <NDC11Code>35356-0867-30</NDC11Code>
    <ProductNDC>35356-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960308</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020254</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-11</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>35356-867-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (35356-867-60)</PackageDescription>
    <NDC11Code>35356-0867-60</NDC11Code>
    <ProductNDC>35356-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960308</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020254</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-11</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>16590-867-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (16590-867-90)</PackageDescription>
    <NDC11Code>16590-0867-90</NDC11Code>
    <ProductNDC>16590-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078858</ApplicationNumber>
    <LabelerName>STAT RX USA LLC</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
    <Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.                          250 mg tablets: FD&amp;C Blue # 2 Lake of indigo carmine.                          500 mg tablets: Ferric oxide yellow.                          750 mg tablets: Ferric oxide red and FD&amp;C # 6 lake of sunset yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-867-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (21695-867-90)</PackageDescription>
    <NDC11Code>21695-0867-90</NDC11Code>
    <ProductNDC>21695-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mirapex</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020667</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Mirapex® (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of MIRAPEX tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see CLINICAL STUDIES).</IndicationAndUsage>
    <Description>MIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S  2HCl  H2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. MIRAPEX tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, cornstarch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-867-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (33261-867-90)</PackageDescription>
    <NDC11Code>33261-0867-90</NDC11Code>
    <ProductNDC>33261-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pravastatin Sodium</ProprietaryName>
    <NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100330</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077751</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Pravastatin sodium tablet is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1) , 2 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2) , 3 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2) , 4 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 5 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).</IndicationAndUsage>
    <Description>Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-867-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-90) </PackageDescription>
    <NDC11Code>43063-0867-90</NDC11Code>
    <ProductNDC>43063-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151230</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090796</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180711</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43353-867-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43353-867-60)</PackageDescription>
    <NDC11Code>43353-0867-60</NDC11Code>
    <ProductNDC>43353-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130618</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076262</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>20; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS,  Head and Neck Angioedema.).</IndicationAndUsage>
    <Description>Lisinopril and hydrochlorothiazide combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2 and its structural formula is: [Enter image caption here]. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. Inactive ingredients are: calcium phosphate, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and starch. Lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg, and 20 mg/25 mg also contain iron oxides.</Description>
  </NDC>
  <NDC>
    <NDCCode>45865-867-90</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-867-90) </PackageDescription>
    <NDC11Code>45865-0867-90</NDC11Code>
    <ProductNDC>45865-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075227</ApplicationNumber>
    <LabelerName>medsource pharmaceuticals</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen delayed-release tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis , 2 osteoarthritis , 3 ankylosing spondylitis , 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of non-steroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (+)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula. C 14H 14O 3 M.W. 230.26. Naproxen, USP is a practically odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. Naproxen Delayed-Release Tablets USP are available as enteric-coated, white to off-white tablets containing 375 mg or 500 mg of naproxen, USP for oral administration. The inactive ingredients are: antifoam DC 1510, corn starch, croscarmellose sodium, FD&amp;C Blue # 2 Aluminum Lake, magnesium stearate, methacrylic acid copolymer-dispersion, povidone, propylene glycol, shellac, talc, titanium dioxide, and triethyl citrate. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>60429-867-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-867-90) </PackageDescription>
    <NDC11Code>60429-0867-90</NDC11Code>
    <ProductNDC>60429-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170324</StartMarketingDate>
    <EndMarketingDate>20241031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205468</ApplicationNumber>
    <LabelerName>Golden State Medical Supply</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>225</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170405</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine hydrochloride extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) ( 1.1) , 2 Social Anxiety Disorder (SAD) (  1.2)  .</IndicationAndUsage>
    <Description>Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is white to off-white crystalline solid with a solubility of 572 mg/ mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 sodium chloride) patition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets is comprised of a matrix system containing.hydrophilic polymers surrounded by an insoluble but permeable coat. After administaration, the soluble components of the coat dissolve and fluid from the gastrointestinal tract enters the tablet through the porous coat, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion and erosion of the polymeric matrix. Tablets contain venlafaxine hydrochloride, USP equivalent to 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, silicified microcrystalline cellulose, opadry, polyethylene glycol, surelease clear,talc, titanium dioxide, triacetin and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-867-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (63187-867-90) </PackageDescription>
    <NDC11Code>63187-0867-90</NDC11Code>
    <ProductNDC>63187-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071135</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&amp;C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&amp;C Blue No. 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-867-16</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (68382-867-16) </PackageDescription>
    <NDC11Code>68382-0867-16</NDC11Code>
    <ProductNDC>68382-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206752</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250214</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white to off-white, colored powder with a pKa1 of 4.2 and a pKa2 of 10.6. 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 – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin. Each capsule contains following inactive ingredients: gelatin, pregelatinised starch, sodium lauryl sulfate, talc and titanium dioxide. Additionally, 50 mg capsules contain iron oxide yellow; 75 mg and 100 mg capsules contain FD &amp; C Yellow 6, and FD &amp; C Red 3; 150 mg capsules contain FD &amp; C Yellow 6, and D &amp; C Yellow 10; 200 mg and 225 mg capsules contain iron oxide red, and iron oxide yellow; and 300 mg capsules contain FD &amp; C Blue 1, FD &amp; C Yellow 6. The capsule body is imprinted with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>69842-867-90</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69842-867-90)  / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>69842-0867-90</NDC11Code>
    <ProductNDC>69842-867</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride Tablets</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078343</ApplicationNumber>
    <LabelerName>CVS Health Corp.</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71205-867-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-90) </PackageDescription>
    <NDC11Code>71205-0867-90</NDC11Code>
    <ProductNDC>71205-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranolazine</ProprietaryName>
    <NonProprietaryName>Ranolazine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210824</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211829</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>RANOLAZINE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-04-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
    <Description>Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, hypromellose, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin, Iron Oxide Yellow, and Iron Oxide Red; additional inactive ingredients for the 1000 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin and Iron Oxide Yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-867-60</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60) </PackageDescription>
    <NDC11Code>71610-0867-60</NDC11Code>
    <ProductNDC>71610-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207427</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24.</Description>
  </NDC>
  <NDC>
    <NDCCode>84197-867-00</NDCCode>
    <PackageDescription>90 mL in 1 BOTTLE (84197-867-00) </PackageDescription>
    <NDC11Code>84197-0867-00</NDC11Code>
    <ProductNDC>84197-867</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Flexdermal Pain Relieving Roll-on</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250124</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>SOLVADERM LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-02-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71610-867-53</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53) </PackageDescription>
    <NDC11Code>71610-0867-53</NDC11Code>
    <ProductNDC>71610-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207427</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-867-70</NDCCode>
    <PackageDescription>120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70) </PackageDescription>
    <NDC11Code>71610-0867-70</NDC11Code>
    <ProductNDC>71610-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207427</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-867-80</NDCCode>
    <PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80) </PackageDescription>
    <NDC11Code>71610-0867-80</NDC11Code>
    <ProductNDC>71610-867</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207427</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride .The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5.HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.86. Metformin Hydrochloride Extended-release Tablets USP, contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-release Tablets, USP 500 mg and 750 mg contain the inactive ingredients hypromellose, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, and magnesium stearate. System Components and Performance-Metformin Hydrochloride Extended-release Tablets comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymers to form a monophasic matrix system. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Dissolution Method: Test 24.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-048-90</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35356-048-90)</PackageDescription>
    <NDC11Code>35356-0048-90</NDC11Code>
    <ProductNDC>35356-048</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kadian</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111221</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020616</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35356-053-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (35356-053-90)</PackageDescription>
    <NDC11Code>35356-0053-90</NDC11Code>
    <ProductNDC>35356-053</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110718</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021724</ApplicationNumber>
    <LabelerName>Lake Erie Medical Surgical &amp; Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LYRICA is indicated for.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-054-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (35356-054-90) </PackageDescription>
    <NDC11Code>35356-0054-90</NDC11Code>
    <ProductNDC>35356-054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lyrica</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20041230</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021446</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>35356-059-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (35356-059-90)</PackageDescription>
    <NDC11Code>35356-0059-90</NDC11Code>
    <ProductNDC>35356-059</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078925</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-27</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>35356-091-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-091-90)</PackageDescription>
    <NDC11Code>35356-0091-90</NDC11Code>
    <ProductNDC>35356-091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycontin</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110609</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020553</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35356-101-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (35356-101-90)</PackageDescription>
    <NDC11Code>35356-0101-90</NDC11Code>
    <ProductNDC>35356-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diovan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120228</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021283</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>320</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-19</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35356-125-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (35356-125-90)</PackageDescription>
    <NDC11Code>35356-0125-90</NDC11Code>
    <ProductNDC>35356-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pravastatin Sodium</ProprietaryName>
    <NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110718</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076341</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35356-176-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (35356-176-90)</PackageDescription>
    <NDC11Code>35356-0176-90</NDC11Code>
    <ProductNDC>35356-176</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pentazocine And Naloxone</ProprietaryName>
    <NonProprietaryName>Pentazocine Hydrochloride And Naloxone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19970121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074736</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50; .5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-26</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>35356-211-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (35356-211-90)</PackageDescription>
    <NDC11Code>35356-0211-90</NDC11Code>
    <ProductNDC>35356-211</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077290</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>35356-212-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (35356-212-90)</PackageDescription>
    <NDC11Code>35356-0212-90</NDC11Code>
    <ProductNDC>35356-212</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077290</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>35356-216-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-216-90)</PackageDescription>
    <NDC11Code>35356-0216-90</NDC11Code>
    <ProductNDC>35356-216</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benicar</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120222</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021286</ApplicationNumber>
    <LabelerName>Lake Erie Medical &amp; Surgical Supply DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-26</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>35356-867-90</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>35356-867-30</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>35356-867-60</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>16590-867-90</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>21695-867-90</NDCCode><ProprietaryName>Mirapex</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33261-867-90</NDCCode><ProprietaryName>Pravastatin Sodium</ProprietaryName><NonProprietaryName>Pravastatin Sodium</NonProprietaryName></NDC><NDC><NDCCode>43063-867-90</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>43353-867-60</NDCCode><ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>45865-867-90</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>60429-867-90</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63187-867-90</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>68382-867-16</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>69842-867-90</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride Tablets</NonProprietaryName></NDC><NDC><NDCCode>71205-867-90</NDCCode><ProprietaryName>Ranolazine</ProprietaryName><NonProprietaryName>Ranolazine</NonProprietaryName></NDC><NDC><NDCCode>71610-867-60</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>84197-867-00</NDCCode><ProprietaryName>Flexdermal Pain Relieving Roll-on</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>71610-867-53</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71610-867-70</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71610-867-80</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-048-90</NDCCode><ProprietaryName>Kadian</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35356-053-90</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>35356-054-90</NDCCode><ProprietaryName>Lyrica</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>35356-059-90</NDCCode><ProprietaryName>Amlodipine Besylate</ProprietaryName><NonProprietaryName>Amlodipine Besylate</NonProprietaryName></NDC><NDC><NDCCode>35356-091-90</NDCCode><ProprietaryName>Oxycontin</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-101-90</NDCCode><ProprietaryName>Diovan</ProprietaryName><NonProprietaryName>Valsartan</NonProprietaryName></NDC><NDC><NDCCode>35356-125-90</NDCCode><ProprietaryName>Pravastatin Sodium</ProprietaryName><NonProprietaryName>Pravastatin Sodium</NonProprietaryName></NDC><NDC><NDCCode>35356-176-90</NDCCode><ProprietaryName>Pentazocine And Naloxone</ProprietaryName><NonProprietaryName>Pentazocine Hydrochloride And Naloxone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-211-90</NDCCode><ProprietaryName>Oxycodone Hydrochloride</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-212-90</NDCCode><ProprietaryName>Oxycodone Hydrochloride</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35356-216-90</NDCCode><ProprietaryName>Benicar</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</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",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "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": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-562-2015",
      "PracticeLocationAddressFaxNumber": "425-562-2010",
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      "PracticeLocationAddressCityName": "ORLANDO",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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",
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}
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