{
"NDC": [
{
"NDCCode": "0440-7483-19",
"PackageDescription": "190 TABLET, COATED in 1 BOTTLE (0440-7483-19)",
"NDC11Code": "00440-7483-19",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "29300-440-19",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (29300-440-19) ",
"NDC11Code": "29300-0440-19",
"ProductNDC": "29300-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219593",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "63776-440-19",
"PackageDescription": "1000 mL in 1 BOTTLE (63776-440-19) ",
"NDC11Code": "63776-0440-19",
"ProductNDC": "63776-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollens Early",
"NonProprietaryName": "Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
"StrengthNumber": "200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210325",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary support of symptoms related to seasonal spring sensitivities."
},
{
"NDCCode": "0440-7483-14",
"PackageDescription": "14 TABLET, COATED in 1 BOTTLE (0440-7483-14)",
"NDC11Code": "00440-7483-14",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "0440-7483-20",
"PackageDescription": "20 TABLET, COATED in 1 BOTTLE (0440-7483-20)",
"NDC11Code": "00440-7483-20",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "0440-7483-28",
"PackageDescription": "28 TABLET, COATED in 1 BOTTLE (0440-7483-28)",
"NDC11Code": "00440-7483-28",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "0440-7483-71",
"PackageDescription": "210 TABLET, COATED in 1 BOTTLE (0440-7483-71)",
"NDC11Code": "00440-7483-71",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "0440-7483-92",
"PackageDescription": "180 TABLET, COATED in 1 BOTTLE (0440-7483-92)",
"NDC11Code": "00440-7483-92",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "0440-7483-95",
"PackageDescription": "360 TABLET, COATED in 1 BOTTLE (0440-7483-95)",
"NDC11Code": "00440-7483-95",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "0440-7483-97",
"PackageDescription": "400 TABLET, COATED in 1 BOTTLE (0440-7483-97)",
"NDC11Code": "00440-7483-97",
"ProductNDC": "0440-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "68788-7483-1",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-1) ",
"NDC11Code": "68788-7483-01",
"ProductNDC": "68788-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208333",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide."
},
{
"NDCCode": "68788-7483-2",
"PackageDescription": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-2) ",
"NDC11Code": "68788-7483-02",
"ProductNDC": "68788-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208333",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide."
},
{
"NDCCode": "68788-7483-3",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-3) ",
"NDC11Code": "68788-7483-03",
"ProductNDC": "68788-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208333",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide."
},
{
"NDCCode": "68788-7483-6",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-6) ",
"NDC11Code": "68788-7483-06",
"ProductNDC": "68788-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208333",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide."
},
{
"NDCCode": "68788-7483-9",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-9) ",
"NDC11Code": "68788-7483-09",
"ProductNDC": "68788-7483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208333",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide."
},
{
"NDCCode": "0440-8069-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0440-8069-01)",
"NDC11Code": "00440-8069-01",
"ProductNDC": "0440-8069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0440-8069-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (0440-8069-10)",
"NDC11Code": "00440-8069-10",
"ProductNDC": "0440-8069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0440-8069-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (0440-8069-12)",
"NDC11Code": "00440-8069-12",
"ProductNDC": "0440-8069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0440-8069-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (0440-8069-20)",
"NDC11Code": "00440-8069-20",
"ProductNDC": "0440-8069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0440-8505-91",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (0440-8505-91)",
"NDC11Code": "00440-8505-91",
"ProductNDC": "0440-8505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride, and has the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10, gelatin, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, and titanium dioxide. The 250 mg capsules also contain black iron oxide, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, and FD&C Yellow #6. The 500 mg capsules also contain ammonium hydroxide, FD&C Blue #1, FD&C Red #40, and simethicone."
},
{
"NDCCode": "16714-440-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-01",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "16714-440-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-02",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "16714-440-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-03",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "16714-440-04",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (16714-440-04) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0440-04",
"ProductNDC": "16714-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deblitane",
"NonProprietaryName": "Norethindrone",
"DosageFormName": "KIT",
"StartMarketingDate": "20130913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202014",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130913",
"SamplePackage": "N",
"IndicationAndUsage": "1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.",
"Description": "Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive."
},
{
"NDCCode": "31722-440-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-440-01) ",
"NDC11Code": "31722-0440-01",
"ProductNDC": "31722-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avanafil",
"NonProprietaryName": "Avanafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209266",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AVANAFIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240614",
"SamplePackage": "N",
"IndicationAndUsage": "Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.",
"Description": "Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate."
},
{
"NDCCode": "31722-440-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (31722-440-30) ",
"NDC11Code": "31722-0440-30",
"ProductNDC": "31722-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avanafil",
"NonProprietaryName": "Avanafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209266",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AVANAFIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240614",
"SamplePackage": "N",
"IndicationAndUsage": "Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.",
"Description": "Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate."
},
{
"NDCCode": "42627-440-01",
"PackageDescription": "1 TUBE in 1 CARTON (42627-440-01) / 50 mL in 1 TUBE",
"NDC11Code": "42627-0440-01",
"ProductNDC": "42627-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla",
"ProprietaryNameSuffix": "Spf 15",
"NonProprietaryName": "Octonoxate, Octisalate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210630",
"EndMarketingDate": "20230818",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Kingdon Animalia, LLC DBA Hourglass Cosmetics",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "7; 4; 4",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210630",
"EndMarketingDatePackage": "20230818",
"SamplePackage": "N"
},
{
"NDCCode": "43857-0440-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43857-0440-1) ",
"NDC11Code": "43857-0440-01",
"ProductNDC": "43857-0440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rheumaforce",
"NonProprietaryName": "Chondrus Crispus, Cimicifuga Racemosa, Spiraea Ulmaria, Trifolium Pratense, Urtica Urens, Xanthoxylum Fraxineum, Symphytum Officinale, Colchicum Autumnale, Ferrum Phosphoricum, Formica Rufa, Lithium Carbonicum, Natrum Sulphuricum, Rhododendron Chrysanthemum, Rhus Tox",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170417",
"EndMarketingDate": "20220417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "BLACK COHOSH; CHONDRUS CRISPUS; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; FILIPENDULA ULMARIA ROOT; FORMICA RUFA; LITHIUM CARBONATE; RHODODENDRON AUREUM LEAF; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA URENS; ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "3; 3; 12; 6; 12; 3; 12; 12; 12; 12; 12; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170417",
"EndMarketingDatePackage": "20220417",
"SamplePackage": "N"
},
{
"NDCCode": "46123-440-01",
"PackageDescription": "1 L in 1 TANK (46123-440-01) ",
"NDC11Code": "46123-0440-01",
"ProductNDC": "46123-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205850",
"LabelerName": "Roberts Oxygen Company, Inc.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020701",
"SamplePackage": "N"
},
{
"NDCCode": "50090-0440-0",
"PackageDescription": "400 g in 1 JAR (50090-0440-0)",
"NDC11Code": "50090-0440-00",
"ProductNDC": "50090-0440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silver Sulfadiazene",
"NonProprietaryName": "Silver Sulfadiazine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19820225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018578",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SILVER SULFADIAZINE",
"StrengthNumber": "10",
"StrengthUnit": "g/1000g",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0440-7483-19</NDCCode>
<PackageDescription>190 TABLET, COATED in 1 BOTTLE (0440-7483-19)</PackageDescription>
<NDC11Code>00440-7483-19</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>29300-440-19</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (29300-440-19) </PackageDescription>
<NDC11Code>29300-0440-19</NDC11Code>
<ProductNDC>29300-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219593</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>63776-440-19</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (63776-440-19) </PackageDescription>
<NDC11Code>63776-0440-19</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0440-7483-14</NDCCode>
<PackageDescription>14 TABLET, COATED in 1 BOTTLE (0440-7483-14)</PackageDescription>
<NDC11Code>00440-7483-14</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0440-7483-20</NDCCode>
<PackageDescription>20 TABLET, COATED in 1 BOTTLE (0440-7483-20)</PackageDescription>
<NDC11Code>00440-7483-20</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0440-7483-28</NDCCode>
<PackageDescription>28 TABLET, COATED in 1 BOTTLE (0440-7483-28)</PackageDescription>
<NDC11Code>00440-7483-28</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0440-7483-71</NDCCode>
<PackageDescription>210 TABLET, COATED in 1 BOTTLE (0440-7483-71)</PackageDescription>
<NDC11Code>00440-7483-71</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0440-7483-92</NDCCode>
<PackageDescription>180 TABLET, COATED in 1 BOTTLE (0440-7483-92)</PackageDescription>
<NDC11Code>00440-7483-92</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0440-7483-95</NDCCode>
<PackageDescription>360 TABLET, COATED in 1 BOTTLE (0440-7483-95)</PackageDescription>
<NDC11Code>00440-7483-95</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0440-7483-97</NDCCode>
<PackageDescription>400 TABLET, COATED in 1 BOTTLE (0440-7483-97)</PackageDescription>
<NDC11Code>00440-7483-97</NDC11Code>
<ProductNDC>0440-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68788-7483-1</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-1) </PackageDescription>
<NDC11Code>68788-7483-01</NDC11Code>
<ProductNDC>68788-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208333</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68788-7483-2</NDCCode>
<PackageDescription>20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-2) </PackageDescription>
<NDC11Code>68788-7483-02</NDC11Code>
<ProductNDC>68788-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208333</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68788-7483-3</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-3) </PackageDescription>
<NDC11Code>68788-7483-03</NDC11Code>
<ProductNDC>68788-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208333</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68788-7483-6</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-6) </PackageDescription>
<NDC11Code>68788-7483-06</NDC11Code>
<ProductNDC>68788-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208333</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68788-7483-9</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7483-9) </PackageDescription>
<NDC11Code>68788-7483-09</NDC11Code>
<ProductNDC>68788-7483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208333</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following:. Treatment of gastroesophageal reflux disease (GERD) (1.1). Risk reduction of NSAID-associated gastric ulcer (1.2). H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2‑ pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 .2H2O with molecular weight of 749.15 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25ºC and about 8 hours at 37ºC.Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0440-8069-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0440-8069-01)</PackageDescription>
<NDC11Code>00440-8069-01</NDC11Code>
<ProductNDC>0440-8069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0440-8069-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (0440-8069-10)</PackageDescription>
<NDC11Code>00440-8069-10</NDC11Code>
<ProductNDC>0440-8069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0440-8069-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (0440-8069-12)</PackageDescription>
<NDC11Code>00440-8069-12</NDC11Code>
<ProductNDC>0440-8069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0440-8069-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (0440-8069-20)</PackageDescription>
<NDC11Code>00440-8069-20</NDC11Code>
<ProductNDC>0440-8069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0440-8505-91</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (0440-8505-91)</PackageDescription>
<NDC11Code>00440-8505-91</NDC11Code>
<ProductNDC>0440-8505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride, and has the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10, gelatin, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, and titanium dioxide. The 250 mg capsules also contain black iron oxide, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, and FD&C Yellow #6. The 500 mg capsules also contain ammonium hydroxide, FD&C Blue #1, FD&C Red #40, and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>16714-440-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-01</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>16714-440-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-02</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>16714-440-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-03</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>16714-440-04</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (16714-440-04) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0440-04</NDC11Code>
<ProductNDC>16714-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deblitane</ProprietaryName>
<NonProprietaryName>Norethindrone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202014</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.</IndicationAndUsage>
<Description>Each yellow DEBLITANETM tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17-alpha-pregn-4-en-20-yn-3-one.The structural formula follows. Therapeutic class = Oral Contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>31722-440-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-440-01) </PackageDescription>
<NDC11Code>31722-0440-01</NDC11Code>
<ProductNDC>31722-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avanafil</ProprietaryName>
<NonProprietaryName>Avanafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209266</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AVANAFIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.</IndicationAndUsage>
<Description>Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>31722-440-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (31722-440-30) </PackageDescription>
<NDC11Code>31722-0440-30</NDC11Code>
<ProductNDC>31722-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avanafil</ProprietaryName>
<NonProprietaryName>Avanafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209266</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AVANAFIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.</IndicationAndUsage>
<Description>Avanafil is a selective inhibitor of cGMP-specific PDE5. Avanafil is designated chemically as (S)-4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]- N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide and has the following structural formula:. Avanafil occurs as an off-white to white powder, molecular formula C 23H 26ClN 7O 3and molecular weight of 483.95 and is slightly soluble in methanol, ethanol and insoluble in water. Avanafil tablets, for oral administration, is supplied as oval, white to off-white tablets containing 50 mg, 100 mg, or 200 mg avanafil. In addition to the active ingredient, avanafil, each tablet contains the following inactive ingredients: fumaric acid, hydroxyl propyl cellulose, low- substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>42627-440-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42627-440-01) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>42627-0440-01</NDC11Code>
<ProductNDC>42627-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla</ProprietaryName>
<ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octonoxate, Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<EndMarketingDate>20230818</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Kingdon Animalia, LLC DBA Hourglass Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7; 4; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<EndMarketingDatePackage>20230818</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43857-0440-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43857-0440-1) </PackageDescription>
<NDC11Code>43857-0440-01</NDC11Code>
<ProductNDC>43857-0440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rheumaforce</ProprietaryName>
<NonProprietaryName>Chondrus Crispus, Cimicifuga Racemosa, Spiraea Ulmaria, Trifolium Pratense, Urtica Urens, Xanthoxylum Fraxineum, Symphytum Officinale, Colchicum Autumnale, Ferrum Phosphoricum, Formica Rufa, Lithium Carbonicum, Natrum Sulphuricum, Rhododendron Chrysanthemum, Rhus Tox</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170417</StartMarketingDate>
<EndMarketingDate>20220417</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>BLACK COHOSH; CHONDRUS CRISPUS; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; FILIPENDULA ULMARIA ROOT; FORMICA RUFA; LITHIUM CARBONATE; RHODODENDRON AUREUM LEAF; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA URENS; ZANTHOXYLUM AMERICANUM BARK</SubstanceName>
<StrengthNumber>3; 3; 12; 6; 12; 3; 12; 12; 12; 12; 12; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170417</StartMarketingDatePackage>
<EndMarketingDatePackage>20220417</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46123-440-01</NDCCode>
<PackageDescription>1 L in 1 TANK (46123-440-01) </PackageDescription>
<NDC11Code>46123-0440-01</NDC11Code>
<ProductNDC>46123-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205850</ApplicationNumber>
<LabelerName>Roberts Oxygen Company, Inc.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-0440-0</NDCCode>
<PackageDescription>400 g in 1 JAR (50090-0440-0)</PackageDescription>
<NDC11Code>50090-0440-00</NDC11Code>
<ProductNDC>50090-0440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silver Sulfadiazene</ProprietaryName>
<NonProprietaryName>Silver Sulfadiazine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19820225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018578</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SILVER SULFADIAZINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/1000g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
</NDCList>