{
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{
"NDCCode": "85766-198-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (85766-198-05) ",
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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{
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
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"SamplePackage": "N",
"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake."
},
{
"NDCCode": "10252-001-05",
"PackageDescription": "198 L in 1 CYLINDER (10252-001-05) ",
"NDC11Code": "10252-0001-05",
"ProductNDC": "10252-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19600101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "Coastal Welding Supply, Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2023-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19600101",
"SamplePackage": "N"
},
{
"NDCCode": "33335-001-05",
"PackageDescription": "198 L in 1 CYLINDER (33335-001-05) ",
"NDC11Code": "33335-0001-05",
"ProductNDC": "33335-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19410101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "WELSCO, INC.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19410101",
"SamplePackage": "N"
},
{
"NDCCode": "36800-743-05",
"PackageDescription": "198 mL in 1 TUBE (36800-743-05) ",
"NDC11Code": "36800-0743-05",
"ProductNDC": "36800-743",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oil Free Acne Wash",
"NonProprietaryName": "Salicylic Acid 2.00%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111117",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Topco",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111117",
"SamplePackage": "N",
"IndicationAndUsage": "Use for the treatment of acne."
},
{
"NDCCode": "49738-207-05",
"PackageDescription": "198 mL in 1 TUBE (49738-207-05)",
"NDC11Code": "49738-0207-05",
"ProductNDC": "49738-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oil Free Acne Wash",
"NonProprietaryName": "Salicylic Acid 2.00%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Kmart Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-15"
},
{
"NDCCode": "50346-001-05",
"PackageDescription": "198 g in 1 JAR (50346-001-05)",
"NDC11Code": "50346-0001-05",
"ProductNDC": "50346-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Petroleum",
"NonProprietaryName": "White Petroleum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120526",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Pan Aromas LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For the temporary protection of minor cuts, scraps, burns and sunburn. Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips."
},
{
"NDCCode": "50346-002-05",
"PackageDescription": "198 g in 1 JAR (50346-002-05)",
"NDC11Code": "50346-0002-05",
"ProductNDC": "50346-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Fresh Scent Petroleum",
"NonProprietaryName": "White Petroleum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120526",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Pan Aromas LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": ".99",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ideal foryour baby’s skin care needs. Restores smooth and healthy skin. Helps totreat and prevent your baby’s delicate skin from diaper rash. It works toseal out wetness. Helps tosoothe dry, chapped, cracked or irritated skin and lips due to cold and wind."
},
{
"NDCCode": "50346-003-05",
"PackageDescription": "198 g in 1 JAR (50346-003-05)",
"NDC11Code": "50346-0003-05",
"ProductNDC": "50346-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Petroleum Cocoa Butter Scented",
"NonProprietaryName": "White Petroleum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120526",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Pan Aromas LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": ".99",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For the temporary protection of minor cuts, scraps, burns and sunburn. Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips."
},
{
"NDCCode": "50580-198-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (50580-198-05) / 15 mL in 1 BOTTLE",
"NDC11Code": "50580-0198-05",
"ProductNDC": "50580-198",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motrin",
"ProprietaryNameSuffix": "Infants",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20010901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020603",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1.25mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260608",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches."
},
{
"NDCCode": "51887-720-05",
"PackageDescription": "198 L in 1 CYLINDER (51887-720-05) ",
"NDC11Code": "51887-0720-05",
"ProductNDC": "51887-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19890101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "Maine Oxy-Acetylene Supply Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19890101",
"SamplePackage": "N"
},
{
"NDCCode": "53425-001-05",
"PackageDescription": "198 L in 1 CYLINDER (53425-001-05) ",
"NDC11Code": "53425-0001-05",
"ProductNDC": "53425-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20100719",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205712",
"LabelerName": "IWS Gas and Supply of Texas, LTD",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100719",
"SamplePackage": "N"
},
{
"NDCCode": "55111-198-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-198-05) ",
"NDC11Code": "55111-0198-05",
"ProductNDC": "55111-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077752",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20061220",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.",
"Description": "Simvastatin USP is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4- hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin USP is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white powder. Practically insoluble in water, freely soluble in chloroform, in alcohol, and in methanol. Sparingly soluble in propylene glycol, very slightly soluble in hexane. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxy anisole, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn starch), and titanium dioxide."
},
{
"NDCCode": "55404-001-05",
"PackageDescription": "198 L in 1 CYLINDER (55404-001-05) ",
"NDC11Code": "55404-0001-05",
"ProductNDC": "55404-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19640101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "Lessors, Incorporated",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19640101",
"SamplePackage": "N"
},
{
"NDCCode": "57472-001-05",
"PackageDescription": "198 L in 1 CYLINDER (57472-001-05)",
"NDC11Code": "57472-0001-05",
"ProductNDC": "57472-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19830101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "AIRGAS NOR PAC INC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "60429-198-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60429-198-05) ",
"NDC11Code": "60429-0198-05",
"ProductNDC": "60429-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19970909",
"EndMarketingDate": "20200201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074587",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141204",
"EndMarketingDatePackage": "20200131",
"SamplePackage": "N"
},
{
"NDCCode": "60779-001-05",
"PackageDescription": "198 L in 1 CYLINDER (60779-001-05) ",
"NDC11Code": "60779-0001-05",
"ProductNDC": "60779-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205712",
"LabelerName": "Latex Welding Supply Inc. dba ARC-La-Tec Welding Supply",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2022-06-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N"
},
{
"NDCCode": "63376-198-05",
"PackageDescription": "100 g in 1 BAG (63376-198-05)",
"NDC11Code": "63376-0198-05",
"ProductNDC": "63376-198",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20081211",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Suzhou Pharmaceutical Technology Co.,Ltd",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "65862-198-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (65862-198-05) ",
"NDC11Code": "65862-0198-05",
"ProductNDC": "65862-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078787",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080131",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "66915-122-05",
"PackageDescription": "198.4 g in 1 BOTTLE, PUMP (66915-122-05)",
"NDC11Code": "66915-0122-05",
"ProductNDC": "66915-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apres Peel Soothing Balm",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110830",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "CoValence, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "67457-198-05",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (67457-198-05) / 5 mL in 1 VIAL, GLASS (67457-198-99) ",
"NDC11Code": "67457-0198-05",
"ProductNDC": "67457-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultiva",
"NonProprietaryName": "Remifentanil Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19961106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020630",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "REMIFENTANIL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19961106",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.",
"Description": "ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3."
},
{
"NDCCode": "67877-198-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (67877-198-05) ",
"NDC11Code": "67877-0198-05",
"ProductNDC": "67877-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
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"IndicationAndUsage": "Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate."
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"PackageDescription": "500 TABLET in 1 BOTTLE (68382-198-05) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
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"RouteName": "ORAL",
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"LabelerName": "Zydus Pharmaceuticals USA Inc.",
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"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
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"IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson's disease (PD) (1.1), 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4, 5, 6, 7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its molecular formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride (monohydrate), USP is a white to almost white crystalline powder and it is freely soluble in water, soluble in methanol, slightly soluble in alcohol and practically insoluble in methylene chloride. Melting occurs in the range of 296o to 301oC, with decomposition. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg. Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, mannitol, magnesium stearate, pregelatinized starch and povidone. Additionally, each 0.125 mg tablet contains D&C red no. 27 aluminum lake, each 0.25 mg tablet contains FD&C blue no. 1 aluminum lake, each 0.5 mg tablet contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake, each 0.75 mg tablet contains ferric oxide red and ferric oxide yellow, each 1 mg tablet contains ferric oxide red and each 1.5 mg tablet contains ferric oxide yellow."
}
]
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<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<LabelerName>Sportpharm LLC</LabelerName>
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<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults (1.8). Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9).</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is:. Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in dehydrated alcohol, in methanol, in acetonitrile and in phosphate buffer at pH values of 2 to 5. Practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each yellow oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients:. 250 mg tablets: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, colloidal silicon dioxide, povidone K-30, stearic acid, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake. 500 mg tablets: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K-30, magnesium stearate, hypromellose, hydroxypropyl cellulose, propylene glycol, talc, vanillin, titanium dioxide, and D&C Yellow No. 10 Aluminium Lake.</Description>
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<NDC>
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<LabelerName>Coastal Welding Supply, Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-23</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>33335-001-05</NDCCode>
<PackageDescription>198 L in 1 CYLINDER (33335-001-05) </PackageDescription>
<NDC11Code>33335-0001-05</NDC11Code>
<ProductNDC>33335-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19410101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>WELSCO, INC.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>36800-743-05</NDCCode>
<PackageDescription>198 mL in 1 TUBE (36800-743-05) </PackageDescription>
<NDC11Code>36800-0743-05</NDC11Code>
<ProductNDC>36800-743</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oil Free Acne Wash</ProprietaryName>
<NonProprietaryName>Salicylic Acid 2.00%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Topco</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use for the treatment of acne.</IndicationAndUsage>
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<NDC>
<NDCCode>49738-207-05</NDCCode>
<PackageDescription>198 mL in 1 TUBE (49738-207-05)</PackageDescription>
<NDC11Code>49738-0207-05</NDC11Code>
<ProductNDC>49738-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oil Free Acne Wash</ProprietaryName>
<NonProprietaryName>Salicylic Acid 2.00%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Kmart Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>50346-001-05</NDCCode>
<PackageDescription>198 g in 1 JAR (50346-001-05)</PackageDescription>
<NDC11Code>50346-0001-05</NDC11Code>
<ProductNDC>50346-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Petroleum</ProprietaryName>
<NonProprietaryName>White Petroleum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Pan Aromas LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary protection of minor cuts, scraps, burns and sunburn. Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50346-002-05</NDCCode>
<PackageDescription>198 g in 1 JAR (50346-002-05)</PackageDescription>
<NDC11Code>50346-0002-05</NDC11Code>
<ProductNDC>50346-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Fresh Scent Petroleum</ProprietaryName>
<NonProprietaryName>White Petroleum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Pan Aromas LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>.99</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ideal foryour baby’s skin care needs. Restores smooth and healthy skin. Helps totreat and prevent your baby’s delicate skin from diaper rash. It works toseal out wetness. Helps tosoothe dry, chapped, cracked or irritated skin and lips due to cold and wind.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50346-003-05</NDCCode>
<PackageDescription>198 g in 1 JAR (50346-003-05)</PackageDescription>
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<ProductNDC>50346-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Petroleum Cocoa Butter Scented</ProprietaryName>
<NonProprietaryName>White Petroleum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Pan Aromas LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>.99</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary protection of minor cuts, scraps, burns and sunburn. Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-198-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50580-198-05) / 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50580-0198-05</NDC11Code>
<ProductNDC>50580-198</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motrin</ProprietaryName>
<ProprietaryNameSuffix>Infants</ProprietaryNameSuffix>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020603</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1.25mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51887-720-05</NDCCode>
<PackageDescription>198 L in 1 CYLINDER (51887-720-05) </PackageDescription>
<NDC11Code>51887-0720-05</NDC11Code>
<ProductNDC>51887-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19890101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>Maine Oxy-Acetylene Supply Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53425-001-05</NDCCode>
<PackageDescription>198 L in 1 CYLINDER (53425-001-05) </PackageDescription>
<NDC11Code>53425-0001-05</NDC11Code>
<ProductNDC>53425-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20100719</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205712</ApplicationNumber>
<LabelerName>IWS Gas and Supply of Texas, LTD</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-198-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-198-05) </PackageDescription>
<NDC11Code>55111-0198-05</NDC11Code>
<ProductNDC>55111-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077752</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.</IndicationAndUsage>
<Description>Simvastatin USP is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4- hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin USP is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white powder. Practically insoluble in water, freely soluble in chloroform, in alcohol, and in methanol. Sparingly soluble in propylene glycol, very slightly soluble in hexane. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxy anisole, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn starch), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55404-001-05</NDCCode>
<PackageDescription>198 L in 1 CYLINDER (55404-001-05) </PackageDescription>
<NDC11Code>55404-0001-05</NDC11Code>
<ProductNDC>55404-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19640101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>Lessors, Incorporated</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19640101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57472-001-05</NDCCode>
<PackageDescription>198 L in 1 CYLINDER (57472-001-05)</PackageDescription>
<NDC11Code>57472-0001-05</NDC11Code>
<ProductNDC>57472-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19830101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>AIRGAS NOR PAC INC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60429-198-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60429-198-05) </PackageDescription>
<NDC11Code>60429-0198-05</NDC11Code>
<ProductNDC>60429-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970909</StartMarketingDate>
<EndMarketingDate>20200201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074587</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141204</StartMarketingDatePackage>
<EndMarketingDatePackage>20200131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60779-001-05</NDCCode>
<PackageDescription>198 L in 1 CYLINDER (60779-001-05) </PackageDescription>
<NDC11Code>60779-0001-05</NDC11Code>
<ProductNDC>60779-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205712</ApplicationNumber>
<LabelerName>Latex Welding Supply Inc. dba ARC-La-Tec Welding Supply</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63376-198-05</NDCCode>
<PackageDescription>100 g in 1 BAG (63376-198-05)</PackageDescription>
<NDC11Code>63376-0198-05</NDC11Code>
<ProductNDC>63376-198</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20081211</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Suzhou Pharmaceutical Technology Co.,Ltd</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65862-198-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (65862-198-05) </PackageDescription>
<NDC11Code>65862-0198-05</NDC11Code>
<ProductNDC>65862-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078787</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each capsule contains the following inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>66915-122-05</NDCCode>
<PackageDescription>198.4 g in 1 BOTTLE, PUMP (66915-122-05)</PackageDescription>
<NDC11Code>66915-0122-05</NDC11Code>
<ProductNDC>66915-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apres Peel Soothing Balm</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>CoValence, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>67457-198-05</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (67457-198-05) / 5 mL in 1 VIAL, GLASS (67457-198-99) </PackageDescription>
<NDC11Code>67457-0198-05</NDC11Code>
<ProductNDC>67457-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultiva</ProprietaryName>
<NonProprietaryName>Remifentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19961106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020630</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>REMIFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961106</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.</IndicationAndUsage>
<Description>ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3.</Description>
</NDC>
<NDC>
<NDCCode>67877-198-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (67877-198-05) </PackageDescription>
<NDC11Code>67877-0198-05</NDC11Code>
<ProductNDC>67877-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078925</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>68382-198-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-198-05) </PackageDescription>
<NDC11Code>68382-0198-05</NDC11Code>
<ProductNDC>68382-198</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078920</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson's disease (PD) (1.1), 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4, 5, 6, 7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its molecular formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride (monohydrate), USP is a white to almost white crystalline powder and it is freely soluble in water, soluble in methanol, slightly soluble in alcohol and practically insoluble in methylene chloride. Melting occurs in the range of 296o to 301oC, with decomposition. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg. Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, mannitol, magnesium stearate, pregelatinized starch and povidone. Additionally, each 0.125 mg tablet contains D&C red no. 27 aluminum lake, each 0.25 mg tablet contains FD&C blue no. 1 aluminum lake, each 0.5 mg tablet contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake, each 0.75 mg tablet contains ferric oxide red and ferric oxide yellow, each 1 mg tablet contains ferric oxide red and each 1.5 mg tablet contains ferric oxide yellow.</Description>
</NDC>
</NDCList>