RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "50201-4216-8",
      "PackageDescription": "18 POUCH in 1 CARTON (50201-4216-8)  > 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "50201-4216-08",
      "ProductNDC": "50201-4216",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Sense Effervescent Antacid And Pain Relief",
      "NonProprietaryName": "Aspirin, Citric Acid, Sodium Bicarbonate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130211",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Tower Laboratories Ltd.",
      "SubstanceName": "ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE",
      "StrengthNumber": "1000; 325; 1916",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190903",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses for the temporary relief of. ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains. ■ upset stomach with headache from overindulgence in food or drink. ■ pain alone (headaches or body aches and pains)."
    },
    {
      "NDCCode": "68071-4216-8",
      "PackageDescription": "28 CAPSULE in 1 BOTTLE (68071-4216-8) ",
      "NDC11Code": "68071-4216-08",
      "ProductNDC": "68071-4216",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA063065",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence . Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species . In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules 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.",
      "Description": "Minocycline hydrochloride  is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C 23H 27N 3O 7HCl                      M.W. 493.94. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn). The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 100 mg capsule shell also contains black iron oxide."
    },
    {
      "NDCCode": "50201-0246-1",
      "PackageDescription": "2 TABLET, EFFERVESCENT in 1 POUCH (50201-0246-1)",
      "NDC11Code": "50201-0246-01",
      "ProductNDC": "50201-0246",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Effervescent Cold Relief",
      "NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Tower Laboratories Ltd",
      "SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
      "StrengthNumber": "325; 2; 7.8",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Uses:temporarily relieves these symptoms of the common cold. - fever - sneezing - nasal congestion - sore throat - headache - minor aches and pains - runny nose - sinus congestion and pressure."
    },
    {
      "NDCCode": "50201-7682-2",
      "PackageDescription": "10 POUCH in 1 CARTON (50201-7682-2)  / 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "50201-7682-02",
      "ProductNDC": "50201-7682",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Top Value Effervescent Cold Relief",
      "NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Tower Laboratories Ltd",
      "SubstanceName": "ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "325; 7.8; 2",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100701",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms of the common cold. ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache. ■ minor aches and pains ■ runny nose. ■ sinus congestion and pressure."
    },
    {
      "NDCCode": "50201-8732-0",
      "PackageDescription": "20 POUCH in 1 CARTON (50201-8732-0)  > 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "50201-8732-00",
      "ProductNDC": "50201-8732",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bubbles R Better Effervescent Cold Relief",
      "NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180424",
      "EndMarketingDate": "20221231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Tower Laboratories Ltd.",
      "SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
      "StrengthNumber": "325; 2; 7.8",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180424",
      "EndMarketingDatePackage": "20221231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50201-8736-0",
      "PackageDescription": "10 POUCH in 1 CARTON (50201-8736-0)  > 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "50201-8736-00",
      "ProductNDC": "50201-8736",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Good Sense Effervescent Cold Relief",
      "NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130219",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Tower Laboratories Ltd.",
      "SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
      "StrengthNumber": "325; 2; 7.8",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190815",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms of the common cold. ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure."
    },
    {
      "NDCCode": "50201-8752-0",
      "PackageDescription": "10 POUCH in 1 CARTON (50201-8752-0)  / 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "50201-8752-00",
      "ProductNDC": "50201-8752",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Top Value Effervescent Cold Relief - Orange",
      "NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210416",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Tower Laboratories Ltd.",
      "SubstanceName": "PHENYLEPHRINE BITARTRATE; ASPIRIN; CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "7.8; 325; 2",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210416",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ temporarily relieves these symptoms due to the common cold. ■ sneezing ■ nasal congestion ■ sore throat. ■ headache ■ minor aches and pains ■ runny nose. ■ sinus congestion and pressure. ■ temporarily reduces fever."
    },
    {
      "NDCCode": "42494-400-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42494-400-01)",
      "NDC11Code": "42494-0400-01",
      "ProductNDC": "42494-400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen Sodium Ds",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018164",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "550",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-400-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (42494-400-05)",
      "NDC11Code": "42494-0400-05",
      "ProductNDC": "42494-400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen Sodium Ds",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018164",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "550",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-402-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42494-402-01)",
      "NDC11Code": "42494-0402-01",
      "ProductNDC": "42494-402",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen Sodium",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018164",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "275",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-403-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (42494-403-05)",
      "NDC11Code": "42494-0403-05",
      "ProductNDC": "42494-403",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017581",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-404-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (42494-404-05)",
      "NDC11Code": "42494-0404-05",
      "ProductNDC": "42494-404",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017581",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "375",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-405-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42494-405-01)",
      "NDC11Code": "42494-0405-01",
      "ProductNDC": "42494-405",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017581",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-405-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (42494-405-10)",
      "NDC11Code": "42494-0405-10",
      "ProductNDC": "42494-405",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017581",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-407-01",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42494-407-01)",
      "NDC11Code": "42494-0407-01",
      "ProductNDC": "42494-407",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "375",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "42494-408-01",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42494-408-01)",
      "NDC11Code": "42494-0408-01",
      "ProductNDC": "42494-408",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Cameron Pharmaceuticals, LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis.",
      "Description": "Naproxen is a proprionic 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen and naproxen sodium have the following structures, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. NAPROXEN (naproxen tablets) is available as yellow tablets containing 250 mg of naproxen, pink tablets containing 375 mg of naproxen and yellow tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, iron oxides, povidone and magnesium stearate. EC-NAPROXEN (naproxen delayed-release tablets) is available as enteric-coated white tablets containing 375 mg of naproxen and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. NAPROXEN SODIUM (naproxen sodium tablets) is available as blue tablets containing 275 mg of naproxen sodium and NAPROXEN SODIUM DS (naproxen sodium tablets) is available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the NAPROXEN SODIUM 275 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4210A, polyethylene glycol 8000 or Opadry YS-1-4215. The coating suspension for the NAPROXEN SODIUM DS 550 mg tablet may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "63629-2484-1",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63629-2484-1) ",
      "NDC11Code": "63629-2484-01",
      "ProductNDC": "63629-2484",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181015",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220907",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM 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 (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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 14NaO 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69437-203-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (69437-203-01) ",
      "NDC11Code": "69437-0203-01",
      "ProductNDC": "69437-203",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Anaprox Ds",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018164",
      "LabelerName": "Canton Laboratories",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "550",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS 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": "NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen) delayed-release tablets and ANAPROX DS (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows. NAPROSYN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROSYN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. ANAPROX DS tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROSYN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROSYN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in ANAPROX DS tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69437-316-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (69437-316-01) ",
      "NDC11Code": "69437-0316-01",
      "ProductNDC": "69437-316",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naprosyn",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017581",
      "LabelerName": "Canton Laboratories",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS 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": "NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen) delayed-release tablets and ANAPROX DS (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows. NAPROSYN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROSYN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. ANAPROX DS tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROSYN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROSYN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in ANAPROX DS tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69437-415-01",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69437-415-01) ",
      "NDC11Code": "69437-0415-01",
      "ProductNDC": "69437-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naprosyn",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Canton Laboratories",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "375",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS 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": "NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen) delayed-release tablets and ANAPROX DS (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows. NAPROSYN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROSYN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. ANAPROX DS tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROSYN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROSYN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in ANAPROX DS tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69437-416-01",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69437-416-01) ",
      "NDC11Code": "69437-0416-01",
      "ProductNDC": "69437-416",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naprosyn",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Canton Laboratories",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS 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": "NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen) delayed-release tablets and ANAPROX DS (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows. NAPROSYN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROSYN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. ANAPROX DS tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROSYN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROSYN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in ANAPROX DS tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69784-500-01",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69784-500-01) ",
      "NDC11Code": "69784-0500-01",
      "ProductNDC": "69784-500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181015",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Woodward Pharma Services LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181015",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM 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 (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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 14NaO 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69784-501-01",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69784-501-01) ",
      "NDC11Code": "69784-0501-01",
      "ProductNDC": "69784-501",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181015",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Woodward Pharma Services LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "375",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181015",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM 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 (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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 14NaO 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69784-505-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (69784-505-01) ",
      "NDC11Code": "69784-0505-01",
      "ProductNDC": "69784-505",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181015",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017581",
      "LabelerName": "Woodward Pharma Services LLC",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181015",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM 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 (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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 14NaO 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "69784-550-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (69784-550-01) ",
      "NDC11Code": "69784-0550-01",
      "ProductNDC": "69784-550",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naproxen Sodium Ds",
      "NonProprietaryName": "Naproxen Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181015",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018164",
      "LabelerName": "Woodward Pharma Services LLC",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "550",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-09-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20181015",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM 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 (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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 14NaO 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "72162-1935-1",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-1935-1) ",
      "NDC11Code": "72162-1935-01",
      "ProductNDC": "72162-1935",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ec-naproxen",
      "NonProprietaryName": "Naproxen",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181015",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020067",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "NAPROXEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240530",
      "SamplePackage": "N",
      "IndicationAndUsage": "NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM 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 (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium 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-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-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 14NaO 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. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216."
    },
    {
      "NDCCode": "50201-0421-2",
      "PackageDescription": "10 POUCH in 1 CARTON (50201-0421-2)  / 2 TABLET, EFFERVESCENT in 1 POUCH",
      "NDC11Code": "50201-0421-02",
      "ProductNDC": "50201-0421",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bromo Seltzer",
      "NonProprietaryName": "Aspirin, Sodium Bicarbonate, Citric Acid",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120716",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Tower Laboratories Ltd",
      "SubstanceName": "SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN",
      "StrengthNumber": "1916; 1000; 325",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120716",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses for the temporary relief of. ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains. ■ upset stomach with headache from overindulgence in food or drink. ■ headache, body aches, and pain alone."
    },
    {
      "NDCCode": "50201-2400-2",
      "PackageDescription": "30 TABLET, EFFERVESCENT in 1 BOX (50201-2400-2)",
      "NDC11Code": "50201-2400-02",
      "ProductNDC": "50201-2400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Towerx Effervescent Potassium",
      "NonProprietaryName": "Potassium Bicarbonate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060106",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Tower Laboratories Ltd",
      "SubstanceName": "POTASSIUM BICARBONATE",
      "StrengthNumber": "25",
      "StrengthUnit": "meq/1",
      "Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "50201-2400-4",
      "PackageDescription": "100 TABLET, EFFERVESCENT in 1 BOX (50201-2400-4)",
      "NDC11Code": "50201-2400-04",
      "ProductNDC": "50201-2400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Towerx Effervescent Potassium",
      "NonProprietaryName": "Potassium Bicarbonate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060106",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Tower Laboratories Ltd",
      "SubstanceName": "POTASSIUM BICARBONATE",
      "StrengthNumber": "25",
      "StrengthUnit": "meq/1",
      "Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "50201-2400-6",
      "PackageDescription": "250 TABLET, EFFERVESCENT in 1 BOX (50201-2400-6)",
      "NDC11Code": "50201-2400-06",
      "ProductNDC": "50201-2400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Towerx Effervescent Potassium",
      "NonProprietaryName": "Potassium Bicarbonate",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060106",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Tower Laboratories Ltd",
      "SubstanceName": "POTASSIUM BICARBONATE",
      "StrengthNumber": "25",
      "StrengthUnit": "meq/1",
      "Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"50201-4216-8","ProprietaryName":"Good Sense Effervescent Antacid And Pain Relief","NonProprietaryName":"Aspirin, Citric Acid, Sodium Bicarbonate"},{"NDCCode":"68071-4216-8","ProprietaryName":"Minocycline Hydrochloride","NonProprietaryName":"Minocycline Hydrochloride"},{"NDCCode":"50201-0246-1","ProprietaryName":"Effervescent Cold Relief","NonProprietaryName":"Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate"},{"NDCCode":"50201-7682-2","ProprietaryName":"Top Value Effervescent Cold Relief","NonProprietaryName":"Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate"},{"NDCCode":"50201-8732-0","ProprietaryName":"Bubbles R Better Effervescent Cold Relief","NonProprietaryName":"Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate"},{"NDCCode":"50201-8736-0","ProprietaryName":"Good Sense Effervescent Cold Relief","NonProprietaryName":"Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate"},{"NDCCode":"50201-8752-0","ProprietaryName":"Top Value Effervescent Cold Relief - Orange","NonProprietaryName":"Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate"},{"NDCCode":"42494-400-01","ProprietaryName":"Naproxen Sodium Ds","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"42494-400-05","ProprietaryName":"Naproxen Sodium Ds","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"42494-402-01","ProprietaryName":"Naproxen Sodium","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"42494-403-05","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"42494-404-05","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"42494-405-01","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"42494-405-10","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"42494-407-01","ProprietaryName":"Ec-naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"42494-408-01","ProprietaryName":"Ec-naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"63629-2484-1","ProprietaryName":"Ec-naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"69437-203-01","ProprietaryName":"Anaprox Ds","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"69437-316-01","ProprietaryName":"Naprosyn","NonProprietaryName":"Naproxen"},{"NDCCode":"69437-415-01","ProprietaryName":"Ec-naprosyn","NonProprietaryName":"Naproxen"},{"NDCCode":"69437-416-01","ProprietaryName":"Ec-naprosyn","NonProprietaryName":"Naproxen"},{"NDCCode":"69784-500-01","ProprietaryName":"Ec-naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"69784-501-01","ProprietaryName":"Ec-naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"69784-505-01","ProprietaryName":"Naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"69784-550-01","ProprietaryName":"Naproxen Sodium Ds","NonProprietaryName":"Naproxen Sodium"},{"NDCCode":"72162-1935-1","ProprietaryName":"Ec-naproxen","NonProprietaryName":"Naproxen"},{"NDCCode":"50201-0421-2","ProprietaryName":"Bromo Seltzer","NonProprietaryName":"Aspirin, Sodium Bicarbonate, Citric Acid"},{"NDCCode":"50201-2400-2","ProprietaryName":"Towerx Effervescent Potassium","NonProprietaryName":"Potassium Bicarbonate"},{"NDCCode":"50201-2400-4","ProprietaryName":"Towerx Effervescent Potassium","NonProprietaryName":"Potassium Bicarbonate"},{"NDCCode":"50201-2400-6","ProprietaryName":"Towerx Effervescent Potassium","NonProprietaryName":"Potassium Bicarbonate"}]}
                    

<NDCList><NDC><NDCCode>50201-4216-8</NDCCode><ProprietaryName>Good Sense Effervescent Antacid And Pain Relief</ProprietaryName><NonProprietaryName>Aspirin, Citric Acid, Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>68071-4216-8</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50201-0246-1</NDCCode><ProprietaryName>Effervescent Cold Relief</ProprietaryName><NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>50201-7682-2</NDCCode><ProprietaryName>Top Value Effervescent Cold Relief</ProprietaryName><NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>50201-8732-0</NDCCode><ProprietaryName>Bubbles R Better Effervescent Cold Relief</ProprietaryName><NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>50201-8736-0</NDCCode><ProprietaryName>Good Sense Effervescent Cold Relief</ProprietaryName><NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>50201-8752-0</NDCCode><ProprietaryName>Top Value Effervescent Cold Relief - Orange</ProprietaryName><NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>42494-400-01</NDCCode><ProprietaryName>Naproxen Sodium Ds</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>42494-400-05</NDCCode><ProprietaryName>Naproxen Sodium Ds</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>42494-402-01</NDCCode><ProprietaryName>Naproxen Sodium</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>42494-403-05</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>42494-404-05</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>42494-405-01</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>42494-405-10</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>42494-407-01</NDCCode><ProprietaryName>Ec-naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>42494-408-01</NDCCode><ProprietaryName>Ec-naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>63629-2484-1</NDCCode><ProprietaryName>Ec-naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>69437-203-01</NDCCode><ProprietaryName>Anaprox Ds</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>69437-316-01</NDCCode><ProprietaryName>Naprosyn</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>69437-415-01</NDCCode><ProprietaryName>Ec-naprosyn</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>69437-416-01</NDCCode><ProprietaryName>Ec-naprosyn</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>69784-500-01</NDCCode><ProprietaryName>Ec-naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>69784-501-01</NDCCode><ProprietaryName>Ec-naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>69784-505-01</NDCCode><ProprietaryName>Naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>69784-550-01</NDCCode><ProprietaryName>Naproxen Sodium Ds</ProprietaryName><NonProprietaryName>Naproxen Sodium</NonProprietaryName></NDC><NDC><NDCCode>72162-1935-1</NDCCode><ProprietaryName>Ec-naproxen</ProprietaryName><NonProprietaryName>Naproxen</NonProprietaryName></NDC><NDC><NDCCode>50201-0421-2</NDCCode><ProprietaryName>Bromo Seltzer</ProprietaryName><NonProprietaryName>Aspirin, Sodium Bicarbonate, Citric Acid</NonProprietaryName></NDC><NDC><NDCCode>50201-2400-2</NDCCode><ProprietaryName>Towerx Effervescent Potassium</ProprietaryName><NonProprietaryName>Potassium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>50201-2400-4</NDCCode><ProprietaryName>Towerx Effervescent Potassium</ProprietaryName><NonProprietaryName>Potassium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>50201-2400-6</NDCCode><ProprietaryName>Towerx Effervescent Potassium</ProprietaryName><NonProprietaryName>Potassium Bicarbonate</NonProprietaryName></NDC></NDCList>