RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "54868-3726-0",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-3726-0)",
      "NDC11Code": "54868-3726-00",
      "ProductNDC": "54868-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cozaar",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020386",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "COZAAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.",
      "Description": "COZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. COZAAR is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. COZAAR 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. COZAAR 25 mg, COZAAR 50 mg, and COZAAR 100 mg may also contain carnauba wax."
    },
    {
      "NDCCode": "54868-3726-1",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-3726-1)",
      "NDC11Code": "54868-3726-01",
      "ProductNDC": "54868-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cozaar",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020386",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "COZAAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.",
      "Description": "COZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. COZAAR is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. COZAAR 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. COZAAR 25 mg, COZAAR 50 mg, and COZAAR 100 mg may also contain carnauba wax."
    },
    {
      "NDCCode": "0409-3726-01",
      "PackageDescription": "10 VIAL, GLASS in 1 PACKAGE (0409-3726-01)  > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0409-3726-10) ",
      "NDC11Code": "00409-3726-01",
      "ProductNDC": "0409-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin",
      "NonProprietaryName": "Ampicillin Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20170801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061395",
      "LabelerName": "Hospira, Inc",
      "SubstanceName": "AMPICILLIN SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170801",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
      "Description": "Ampicillin for injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for injection, USP is a white to cream-tinged, crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
    },
    {
      "NDCCode": "15592-3726-1",
      "PackageDescription": "174 kg in 1 DRUM (15592-3726-1) ",
      "NDC11Code": "15592-3726-01",
      "ProductNDC": "15592-3726",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Petrolatum",
      "DosageFormName": "OINTMENT",
      "StartMarketingDate": "20200101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Sonneborn, LLC",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-16",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-20"
    },
    {
      "NDCCode": "37662-3726-1",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-3726-1) ",
      "NDC11Code": "37662-3726-01",
      "ProductNDC": "37662-3726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Strontium Oxydatum",
      "NonProprietaryName": "Strontium Oxydatum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230816",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "STRONTIUM OXIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2023-08-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230816",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37662-3726-2",
      "PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-3726-2) ",
      "NDC11Code": "37662-3726-02",
      "ProductNDC": "37662-3726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Strontium Oxydatum",
      "NonProprietaryName": "Strontium Oxydatum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230816",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "STRONTIUM OXIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2023-08-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230816",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37662-3726-3",
      "PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-3726-3) ",
      "NDC11Code": "37662-3726-03",
      "ProductNDC": "37662-3726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Strontium Oxydatum",
      "NonProprietaryName": "Strontium Oxydatum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230816",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "STRONTIUM OXIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2023-08-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230816",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37662-3726-4",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-3726-4) ",
      "NDC11Code": "37662-3726-04",
      "ProductNDC": "37662-3726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Strontium Oxydatum",
      "NonProprietaryName": "Strontium Oxydatum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230816",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "STRONTIUM OXIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2023-08-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230816",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55154-3726-9",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (55154-3726-9)",
      "NDC11Code": "55154-3726-09",
      "ProductNDC": "55154-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075350",
      "LabelerName": "Cardinal Health",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2017-04-24"
    },
    {
      "NDCCode": "63629-3726-1",
      "PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-3726-1) ",
      "NDC11Code": "63629-3726-01",
      "ProductNDC": "63629-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090066",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240402",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
      "Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2                           M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow)."
    },
    {
      "NDCCode": "68071-3726-9",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68071-3726-9) ",
      "NDC11Code": "68071-3726-09",
      "ProductNDC": "68071-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levocetirizine Dihydrochloride",
      "NonProprietaryName": "Levocetirizine Dihydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110906",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090199",
      "LabelerName": "NuCare Pharmaceuticals, Inc.",
      "SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241122",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levocetirizine dihydrochloride tablets are a histamine H 1-receptor antagonist indicated for: : 1 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2) .",
      "Description": "Levocetirizine dihydrochloride, USP, the active component of Levocetirizine Dihydrochloride Tablets USP, is an orally active H 1-receptor antagonist. The chemical name is R-(+)-2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride, USP is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The chemical structure is shown below:. C 21H 25ClN 2O 32HCl M.W. 461.8. Levocetirizine dihydrochloride, USP is a white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine Dihydrochloride Tablets USP, 5 mg are formulated as immediate-release white to off-white, film-coated, oval-shaped, scored tablets for oral administration. One side of the tablet is scored in half and debossed with the number \"9\" on one side of the score and \"3\" on the other. The other side of the tablet is debossed with the number \"7701.\" Inactive ingredients are: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
    },
    {
      "NDCCode": "70518-3726-0",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-3726-0) ",
      "NDC11Code": "70518-3726-00",
      "ProductNDC": "70518-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074140",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen tablets are indicated for: the relief of the signs and symptoms of:  rheumatoid arthritis  osteoarthritis  ankylosing spondylitis  Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets is also indicated for: the relief of signs and symptoms of:.  tendonitis  bursitis  acute gout the management of:  pain  primary dysmenorrhea.",
      "Description": "Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as White to off-white 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6­ methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an 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 at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone."
    },
    {
      "NDCCode": "70518-3726-1",
      "PackageDescription": "6 TABLET in 1 BLISTER PACK (70518-3726-1) ",
      "NDC11Code": "70518-3726-01",
      "ProductNDC": "70518-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074140",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230524",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen tablets are indicated for: the relief of the signs and symptoms of:  rheumatoid arthritis  osteoarthritis  ankylosing spondylitis  Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets is also indicated for: the relief of signs and symptoms of:.  tendonitis  bursitis  acute gout the management of:  pain  primary dysmenorrhea.",
      "Description": "Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as White to off-white 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6­ methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an 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 at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone."
    },
    {
      "NDCCode": "70518-3726-2",
      "PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (70518-3726-2) ",
      "NDC11Code": "70518-3726-02",
      "ProductNDC": "70518-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074140",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230524",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen tablets are indicated for: the relief of the signs and symptoms of:  rheumatoid arthritis  osteoarthritis  ankylosing spondylitis  Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets is also indicated for: the relief of signs and symptoms of:.  tendonitis  bursitis  acute gout the management of:  pain  primary dysmenorrhea.",
      "Description": "Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as White to off-white 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6­ methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an 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 at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone."
    },
    {
      "NDCCode": "70518-3726-3",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (70518-3726-3) ",
      "NDC11Code": "70518-3726-03",
      "ProductNDC": "70518-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074140",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230608",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen tablets are indicated for: the relief of the signs and symptoms of:  rheumatoid arthritis  osteoarthritis  ankylosing spondylitis  Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets is also indicated for: the relief of signs and symptoms of:.  tendonitis  bursitis  acute gout the management of:  pain  primary dysmenorrhea.",
      "Description": "Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as White to off-white 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6­ methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an 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 at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone."
    },
    {
      "NDCCode": "70518-3726-4",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70518-3726-4) ",
      "NDC11Code": "70518-3726-04",
      "ProductNDC": "70518-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074140",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230612",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen tablets are indicated for: the relief of the signs and symptoms of:  rheumatoid arthritis  osteoarthritis  ankylosing spondylitis  Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets is also indicated for: the relief of signs and symptoms of:.  tendonitis  bursitis  acute gout the management of:  pain  primary dysmenorrhea.",
      "Description": "Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as White to off-white 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6­ methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an 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 at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone."
    },
    {
      "NDCCode": "70518-3726-5",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (70518-3726-5) ",
      "NDC11Code": "70518-3726-05",
      "ProductNDC": "70518-3726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074140",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230621",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naproxen tablets are indicated for: the relief of the signs and symptoms of:  rheumatoid arthritis  osteoarthritis  ankylosing spondylitis  Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets is also indicated for: the relief of signs and symptoms of:.  tendonitis  bursitis  acute gout the management of:  pain  primary dysmenorrhea.",
      "Description": "Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as White to off-white 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6­ methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an 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 at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone."
    },
    {
      "NDCCode": "54868-0010-0",
      "PackageDescription": ".296 mL in 1 BOTTLE, GLASS (54868-0010-0)",
      "NDC11Code": "54868-0010-00",
      "ProductNDC": "54868-0010",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Citrate Of Magnesium",
      "NonProprietaryName": "Citrate Of Magnesium",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030129",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "MAGNESIUM CITRATE",
      "StrengthNumber": "1.745",
      "StrengthUnit": "g/29.6mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "54868-0016-0",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-0016-0)  > 10 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "54868-0016-00",
      "ProductNDC": "54868-0016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dulcolax",
      "NonProprietaryName": "Bisacodyl",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100519",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "BISACODYL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
    },
    {
      "NDCCode": "54868-0017-1",
      "PackageDescription": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-1)",
      "NDC11Code": "54868-0017-01",
      "ProductNDC": "54868-0017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Niaspan",
      "NonProprietaryName": "Niacin",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090512",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020381",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "NIACIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
      "Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0017-2",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-2)",
      "NDC11Code": "54868-0017-02",
      "ProductNDC": "54868-0017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Niaspan",
      "NonProprietaryName": "Niacin",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090512",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020381",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "NIACIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
      "Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0017-5",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-5)",
      "NDC11Code": "54868-0017-05",
      "ProductNDC": "54868-0017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Niaspan",
      "NonProprietaryName": "Niacin",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090512",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020381",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "NIACIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
      "Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0017-6",
      "PackageDescription": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-6)",
      "NDC11Code": "54868-0017-06",
      "ProductNDC": "54868-0017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Niaspan",
      "NonProprietaryName": "Niacin",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090512",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020381",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "NIACIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
      "Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0018-1",
      "PackageDescription": "40 TABLET in 1 BOTTLE (54868-0018-1)",
      "NDC11Code": "54868-0018-01",
      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
      "NonProprietaryName": "Erythromycin Ethylsuccinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0018-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE (54868-0018-3)",
      "NDC11Code": "54868-0018-03",
      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
      "NonProprietaryName": "Erythromycin Ethylsuccinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0018-4",
      "PackageDescription": "30 TABLET in 1 BOTTLE (54868-0018-4)",
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      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
      "NonProprietaryName": "Erythromycin Ethylsuccinate",
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      "RouteName": "ORAL",
      "StartMarketingDate": "19960227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0018-5",
      "PackageDescription": "15 TABLET in 1 BOTTLE (54868-0018-5)",
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      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
      "NonProprietaryName": "Erythromycin Ethylsuccinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0018-6",
      "PackageDescription": "120 TABLET in 1 BOTTLE (54868-0018-6)",
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      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
      "NonProprietaryName": "Erythromycin Ethylsuccinate",
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      "RouteName": "ORAL",
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      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0018-7",
      "PackageDescription": "100 TABLET in 1 BOTTLE (54868-0018-7)",
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      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
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      "RouteName": "ORAL",
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      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
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      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0018-9",
      "PackageDescription": "60 TABLET in 1 BOTTLE (54868-0018-9)",
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      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
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      "RouteName": "ORAL",
      "StartMarketingDate": "19960227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    }
  ]
}
                    

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