{
"NDC": [
{
"NDCCode": "49288-0226-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0226-2)",
"NDC11Code": "49288-0226-02",
"ProductNDC": "49288-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sweet Gum",
"NonProprietaryName": "Sweet Gum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "LIQUIDAMBAR STYRACIFLUA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0226-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0226-5)",
"NDC11Code": "49288-0226-05",
"ProductNDC": "49288-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sweet Gum",
"NonProprietaryName": "Sweet Gum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "LIQUIDAMBAR STYRACIFLUA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0226-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0226-1)",
"NDC11Code": "49288-0226-01",
"ProductNDC": "49288-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sweet Gum",
"NonProprietaryName": "Sweet Gum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "LIQUIDAMBAR STYRACIFLUA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0226-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0226-3)",
"NDC11Code": "49288-0226-03",
"ProductNDC": "49288-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sweet Gum",
"NonProprietaryName": "Sweet Gum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "LIQUIDAMBAR STYRACIFLUA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0226-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0226-4)",
"NDC11Code": "49288-0226-04",
"ProductNDC": "49288-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sweet Gum",
"NonProprietaryName": "Sweet Gum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "LIQUIDAMBAR STYRACIFLUA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "0363-0226-10",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0363-0226-10) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "00363-0226-10",
"ProductNDC": "0363-0226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stay Awake",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961121",
"EndMarketingDate": "20231221",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part340",
"LabelerName": "Walgreen Company",
"SubstanceName": "CAFFEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961121",
"EndMarketingDatePackage": "20230225",
"SamplePackage": "N"
},
{
"NDCCode": "15631-0226-5",
"PackageDescription": "12500 PELLET in 1 PACKAGE (15631-0226-5) ",
"NDC11Code": "15631-0226-05",
"ProductNDC": "15631-0226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrastis Canadensis",
"NonProprietaryName": "Hydrastis Canadensis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151002",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "GOLDENSEAL",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "49452-0226-1",
"PackageDescription": "5 g in 1 BOTTLE, GLASS (49452-0226-1) ",
"NDC11Code": "49452-0226-01",
"ProductNDC": "49452-0226",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19910601",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2023-10-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-JUN-91"
},
{
"NDCCode": "49452-0226-5",
"PackageDescription": "5000 g in 1 PAIL (49452-0226-5) ",
"NDC11Code": "49452-0226-05",
"ProductNDC": "49452-0226",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19910601",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2023-10-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-JUN-91"
},
{
"NDCCode": "61941-0226-5",
"PackageDescription": "36 BOX in 1 CASE (61941-0226-5) > 4 BLISTER PACK in 1 BOX (61941-0226-4) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (61941-0226-1)",
"NDC11Code": "61941-0226-05",
"ProductNDC": "61941-0226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold-eeze",
"ProprietaryNameSuffix": "Natural Multi-symptom Relief",
"NonProprietaryName": "Zinc Gluconate, Sambucus Nigra Flower, Eupatorium Perfoliatum Flowering Top, Mentha Piperita, Myrrh, And Glycyrrhiza Glabra Leaf",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ProPhase Labs, Inc.",
"SubstanceName": "ZINC GLUCONATE; SAMBUCUS NIGRA FLOWER; EUPATORIUM PERFOLIATUM FLOWERING TOP; MENTHA PIPERITA; MYRRH; GLYCYRRHIZA GLABRA LEAF",
"StrengthNumber": "1; 1; 1; 2; 2; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Take one QuickMelt every 2-4 hours per Directions on other side. : 1 to reduce the duration of the common cold, 2 reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest congestion post nasal drip and/or hoarseness, 3 helps for temporary relief of Sore Throat."
},
{
"NDCCode": "62705-0226-2",
"PackageDescription": "1 BAG in 1 DRUM (62705-0226-2) / 5 kg in 1 BAG",
"NDC11Code": "62705-0226-02",
"ProductNDC": "62705-0226",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sulfadimethoxine Na",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Valens Molecules Private Limited",
"SubstanceName": "SULFADIMETHOXINE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "10-MAR-22"
},
{
"NDCCode": "62705-0226-5",
"PackageDescription": "1 BAG in 1 DRUM (62705-0226-5) / 50 kg in 1 BAG",
"NDC11Code": "62705-0226-05",
"ProductNDC": "62705-0226",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sulfadimethoxine Na",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Valens Molecules Private Limited",
"SubstanceName": "SULFADIMETHOXINE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "10-MAR-22"
},
{
"NDCCode": "80425-0226-1",
"PackageDescription": "1 KIT in 1 CARTON (80425-0226-1) * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 5 mL in 1 POUCH * 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1573-5) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "80425-0226-01",
"ProductNDC": "80425-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multi-specialty Kit",
"NonProprietaryName": "Depo-medrol, Lidocaine, Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL",
"StartMarketingDate": "20230512",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Rx Pharmacy of Tennessee, LLC",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230512",
"SamplePackage": "N"
},
{
"NDCCode": "83516-0226-1",
"PackageDescription": "96 TRAY in 1 CASE (83516-0226-1) / 45 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE",
"NDC11Code": "83516-0226-01",
"ProductNDC": "83516-0226",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20241227",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Resilience US, Inc.",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/.5mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "27-DEC-24"
},
{
"NDCCode": "85302-226-50",
"PackageDescription": "50 g in 1 BOTTLE, PUMP (85302-226-50) ",
"NDC11Code": "85302-0226-50",
"ProductNDC": "85302-226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Illuminating Daily Spf40 Non-tinted",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Face 5, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevents sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "0713-0226-15",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0226-15) > 15 g in 1 TUBE",
"NDC11Code": "00713-0226-15",
"ProductNDC": "0713-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089797",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP."
},
{
"NDCCode": "0713-0226-80",
"PackageDescription": "1 TUBE in 1 CARTON (0713-0226-80) > 80 g in 1 TUBE",
"NDC11Code": "00713-0226-80",
"ProductNDC": "0713-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089797",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP."
},
{
"NDCCode": "0832-0226-00",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0226-00) ",
"NDC11Code": "00832-0226-00",
"ProductNDC": "0832-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202104",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130630",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
"Description": "Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&C blue #1, FD&C red #40 (10 mg); D&C yellow #10 (20 mg); FD&C blue #1, FD&C red #40 (30 mg); FD&C blue #1, FD&C red #40 (50 mg); FD&C blue #1, FD&C red #40 (60 mg); FD&C red #40, FD&C yellow #6 (80 mg); FD&C yellow #10, FD&C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:."
},
{
"NDCCode": "0832-0226-50",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0226-50) ",
"NDC11Code": "00832-0226-50",
"ProductNDC": "0832-0226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202104",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130630",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
"Description": "Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&C blue #1, FD&C red #40 (10 mg); D&C yellow #10 (20 mg); FD&C blue #1, FD&C red #40 (30 mg); FD&C blue #1, FD&C red #40 (50 mg); FD&C blue #1, FD&C red #40 (60 mg); FD&C red #40, FD&C yellow #6 (80 mg); FD&C yellow #10, FD&C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:."
},
{
"NDCCode": "14141-226-01",
"PackageDescription": "30 mL in 1 JAR (14141-226-01) ",
"NDC11Code": "14141-0226-01",
"ProductNDC": "14141-226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Matte Pro Defense Base Mate Con Multiproteccion De La Piel Fps 20 Matte Foundation With Skin Multiprotection Spf 20 Mokaccino 390-n",
"NonProprietaryName": "Zinc Oxide,octinoxate",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210414",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "5; 4.2",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210414",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor ifrash occurs."
},
{
"NDCCode": "15127-226-10",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (15127-226-10) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "15127-0226-10",
"ProductNDC": "15127-226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stay Alert",
"ProprietaryNameSuffix": "Alertness Aid",
"NonProprietaryName": "Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961121",
"EndMarketingDate": "20210803",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part340",
"LabelerName": "L&R Distributors, Inc.",
"SubstanceName": "CAFFEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19961121",
"EndMarketingDatePackage": "20210803",
"SamplePackage": "N"
},
{
"NDCCode": "16714-226-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-226-01) ",
"NDC11Code": "16714-0226-01",
"ProductNDC": "16714-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091629",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240904",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22C1KN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8C1N3O4S2 and its structural formula is. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch(maize), and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium. Meets USP Dissolution Test 2."
},
{
"NDCCode": "16714-226-02",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16714-226-02) ",
"NDC11Code": "16714-0226-02",
"ProductNDC": "16714-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091629",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240904",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22C1KN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8C1N3O4S2 and its structural formula is. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch(maize), and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium. Meets USP Dissolution Test 2."
},
{
"NDCCode": "16714-226-04",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-226-04) ",
"NDC11Code": "16714-0226-04",
"ProductNDC": "16714-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091629",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240904",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22C1KN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8C1N3O4S2 and its structural formula is. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch(maize), and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium. Meets USP Dissolution Test 2."
},
{
"NDCCode": "16714-226-06",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (16714-226-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "16714-0226-06",
"ProductNDC": "16714-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"EndMarketingDate": "20220731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091629",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
"StrengthNumber": "12.5; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101006",
"EndMarketingDatePackage": "20220731",
"SamplePackage": "N"
},
{
"NDCCode": "17478-226-12",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-226-12) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17478-0226-12",
"ProductNDC": "17478-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pilocarpine Hydrochloride",
"NonProprietaryName": "Pilocarpine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204398",
"LabelerName": "Akorn",
"SubstanceName": "PILOCARPINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Pilocarpine hydrochloride ophthalmic solution is indicated for the.",
"Description": "Pilocarpine Hydrochloride Ophthalmic Solution, USP is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:. Established name: Pilocarpine hydrochloride. Chemical name: 2(3H)-furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)-methyl]-monohydrochloride, (3S-cis)-. Molecular Formula: C11H16N2O2 HCl. Molecular Weight: 244.72. Each mL of Pilocarpine Hydrochloride Ophthalmic Solution, USP contains:. Active: Pilocarpine hydrochloride 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). Preservative: Benzalkonium chloride 0.01%. Inactives: Hypromellose (2910) 5 mg (0.5%), boric acid, sodium citrate, sodium chloride (present in 1% only); hydrochloric acid and/or sodium hydroxide (to adjust pH); water for injection. Pilocarpine Hydrochloride Ophthalmic Solution, USP has a pH of 3.5 to 5.5 and an osmolality of 270 to 350 mOsm/kg (1% product), 290 to 350 mOsm/kg (2% product) and 500 to 600 mOsm/kg (4% product)."
},
{
"NDCCode": "21130-226-10",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (21130-226-10) / 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "21130-0226-10",
"ProductNDC": "21130-226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stay Awake",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961121",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M011",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "CAFFEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19961121",
"SamplePackage": "N",
"IndicationAndUsage": "helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness."
},
{
"NDCCode": "21695-226-30",
"PackageDescription": "30 TABLET, COATED in 1 CARTON (21695-226-30)",
"NDC11Code": "21695-0226-30",
"ProductNDC": "21695-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lunesta",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021476",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. LUNESTA tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
},
{
"NDCCode": "22840-0226-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0226-2) ",
"NDC11Code": "22840-0226-02",
"ProductNDC": "22840-0226",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Timothy-orchard Standardized Grass Pollen Mix",
"NonProprietaryName": "Phleum Pratense And Dactylis Glomerata",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101843",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "5000; 5000",
"StrengthUnit": "[BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "29300-226-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-01) ",
"NDC11Code": "29300-0226-01",
"ProductNDC": "29300-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203458",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140601",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets, USP 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49288-0226-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0226-2)</PackageDescription>
<NDC11Code>49288-0226-02</NDC11Code>
<ProductNDC>49288-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sweet Gum</ProprietaryName>
<NonProprietaryName>Sweet Gum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>LIQUIDAMBAR STYRACIFLUA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0226-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0226-5)</PackageDescription>
<NDC11Code>49288-0226-05</NDC11Code>
<ProductNDC>49288-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sweet Gum</ProprietaryName>
<NonProprietaryName>Sweet Gum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>LIQUIDAMBAR STYRACIFLUA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0226-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0226-1)</PackageDescription>
<NDC11Code>49288-0226-01</NDC11Code>
<ProductNDC>49288-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sweet Gum</ProprietaryName>
<NonProprietaryName>Sweet Gum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>LIQUIDAMBAR STYRACIFLUA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0226-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0226-3)</PackageDescription>
<NDC11Code>49288-0226-03</NDC11Code>
<ProductNDC>49288-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sweet Gum</ProprietaryName>
<NonProprietaryName>Sweet Gum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>LIQUIDAMBAR STYRACIFLUA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0226-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0226-4)</PackageDescription>
<NDC11Code>49288-0226-04</NDC11Code>
<ProductNDC>49288-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sweet Gum</ProprietaryName>
<NonProprietaryName>Sweet Gum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>LIQUIDAMBAR STYRACIFLUA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>0363-0226-10</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0363-0226-10) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00363-0226-10</NDC11Code>
<ProductNDC>0363-0226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stay Awake</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961121</StartMarketingDate>
<EndMarketingDate>20231221</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part340</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>CAFFEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961121</StartMarketingDatePackage>
<EndMarketingDatePackage>20230225</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15631-0226-5</NDCCode>
<PackageDescription>12500 PELLET in 1 PACKAGE (15631-0226-5) </PackageDescription>
<NDC11Code>15631-0226-05</NDC11Code>
<ProductNDC>15631-0226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrastis Canadensis</ProprietaryName>
<NonProprietaryName>Hydrastis Canadensis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151002</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>GOLDENSEAL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49452-0226-1</NDCCode>
<PackageDescription>5 g in 1 BOTTLE, GLASS (49452-0226-1) </PackageDescription>
<NDC11Code>49452-0226-01</NDC11Code>
<ProductNDC>49452-0226</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19910601</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-10-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUN-91</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49452-0226-5</NDCCode>
<PackageDescription>5000 g in 1 PAIL (49452-0226-5) </PackageDescription>
<NDC11Code>49452-0226-05</NDC11Code>
<ProductNDC>49452-0226</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19910601</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-10-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUN-91</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61941-0226-5</NDCCode>
<PackageDescription>36 BOX in 1 CASE (61941-0226-5) > 4 BLISTER PACK in 1 BOX (61941-0226-4) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (61941-0226-1)</PackageDescription>
<NDC11Code>61941-0226-05</NDC11Code>
<ProductNDC>61941-0226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold-eeze</ProprietaryName>
<ProprietaryNameSuffix>Natural Multi-symptom Relief</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Gluconate, Sambucus Nigra Flower, Eupatorium Perfoliatum Flowering Top, Mentha Piperita, Myrrh, And Glycyrrhiza Glabra Leaf</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ProPhase Labs, Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE; SAMBUCUS NIGRA FLOWER; EUPATORIUM PERFOLIATUM FLOWERING TOP; MENTHA PIPERITA; MYRRH; GLYCYRRHIZA GLABRA LEAF</SubstanceName>
<StrengthNumber>1; 1; 1; 2; 2; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Take one QuickMelt every 2-4 hours per Directions on other side. : 1 to reduce the duration of the common cold, 2 reduces the severity of cold and flu symptoms: cough, sore throat, nasal and chest congestion post nasal drip and/or hoarseness, 3 helps for temporary relief of Sore Throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62705-0226-2</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (62705-0226-2) / 5 kg in 1 BAG</PackageDescription>
<NDC11Code>62705-0226-02</NDC11Code>
<ProductNDC>62705-0226</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sulfadimethoxine Na</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Valens Molecules Private Limited</LabelerName>
<SubstanceName>SULFADIMETHOXINE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62705-0226-5</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (62705-0226-5) / 50 kg in 1 BAG</PackageDescription>
<NDC11Code>62705-0226-05</NDC11Code>
<ProductNDC>62705-0226</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sulfadimethoxine Na</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Valens Molecules Private Limited</LabelerName>
<SubstanceName>SULFADIMETHOXINE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>80425-0226-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (80425-0226-1) * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 5 mL in 1 POUCH * 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1573-5) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>80425-0226-01</NDC11Code>
<ProductNDC>80425-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multi-specialty Kit</ProprietaryName>
<NonProprietaryName>Depo-medrol, Lidocaine, Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL</RouteName>
<StartMarketingDate>20230512</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83516-0226-1</NDCCode>
<PackageDescription>96 TRAY in 1 CASE (83516-0226-1) / 45 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83516-0226-01</NDC11Code>
<ProductNDC>83516-0226</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20241227</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Resilience US, Inc.</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-DEC-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>85302-226-50</NDCCode>
<PackageDescription>50 g in 1 BOTTLE, PUMP (85302-226-50) </PackageDescription>
<NDC11Code>85302-0226-50</NDC11Code>
<ProductNDC>85302-226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Illuminating Daily Spf40 Non-tinted</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240417</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Face 5, LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevents sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0713-0226-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0713-0226-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00713-0226-15</NDC11Code>
<ProductNDC>0713-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089797</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.</Description>
</NDC>
<NDC>
<NDCCode>0713-0226-80</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0713-0226-80) > 80 g in 1 TUBE</PackageDescription>
<NDC11Code>00713-0226-80</NDC11Code>
<ProductNDC>0713-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089797</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains triamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24H 31FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.</Description>
</NDC>
<NDC>
<NDCCode>0832-0226-00</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0226-00) </PackageDescription>
<NDC11Code>00832-0226-00</NDC11Code>
<ProductNDC>0832-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202104</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&C blue #1, FD&C red #40 (10 mg); D&C yellow #10 (20 mg); FD&C blue #1, FD&C red #40 (30 mg); FD&C blue #1, FD&C red #40 (50 mg); FD&C blue #1, FD&C red #40 (60 mg); FD&C red #40, FD&C yellow #6 (80 mg); FD&C yellow #10, FD&C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>0832-0226-50</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0226-50) </PackageDescription>
<NDC11Code>00832-0226-50</NDC11Code>
<ProductNDC>0832-0226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202104</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&C blue #1, FD&C red #40 (10 mg); D&C yellow #10 (20 mg); FD&C blue #1, FD&C red #40 (30 mg); FD&C blue #1, FD&C red #40 (50 mg); FD&C blue #1, FD&C red #40 (60 mg); FD&C red #40, FD&C yellow #6 (80 mg); FD&C yellow #10, FD&C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>14141-226-01</NDCCode>
<PackageDescription>30 mL in 1 JAR (14141-226-01) </PackageDescription>
<NDC11Code>14141-0226-01</NDC11Code>
<ProductNDC>14141-226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Matte Pro Defense Base Mate Con Multiproteccion De La Piel Fps 20 Matte Foundation With Skin Multiprotection Spf 20 Mokaccino 390-n</ProprietaryName>
<NonProprietaryName>Zinc Oxide,octinoxate</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210414</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>5; 4.2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210414</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor ifrash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15127-226-10</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (15127-226-10) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15127-0226-10</NDC11Code>
<ProductNDC>15127-226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stay Alert</ProprietaryName>
<ProprietaryNameSuffix>Alertness Aid</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961121</StartMarketingDate>
<EndMarketingDate>20210803</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part340</ApplicationNumber>
<LabelerName>L&R Distributors, Inc.</LabelerName>
<SubstanceName>CAFFEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961121</StartMarketingDatePackage>
<EndMarketingDatePackage>20210803</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>16714-226-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-226-01) </PackageDescription>
<NDC11Code>16714-0226-01</NDC11Code>
<ProductNDC>16714-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091629</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22C1KN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8C1N3O4S2 and its structural formula is. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch(maize), and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16714-226-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16714-226-02) </PackageDescription>
<NDC11Code>16714-0226-02</NDC11Code>
<ProductNDC>16714-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091629</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22C1KN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8C1N3O4S2 and its structural formula is. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch(maize), and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16714-226-04</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16714-226-04) </PackageDescription>
<NDC11Code>16714-0226-04</NDC11Code>
<ProductNDC>16714-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091629</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22C1KN6O, and its structural formula is. Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8C1N3O4S2 and its structural formula is. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch(maize), and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16714-226-06</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (16714-226-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0226-06</NDC11Code>
<ProductNDC>16714-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<EndMarketingDate>20220731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091629</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>12.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101006</StartMarketingDatePackage>
<EndMarketingDatePackage>20220731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-226-12</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17478-226-12) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17478-0226-12</NDC11Code>
<ProductNDC>17478-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pilocarpine Hydrochloride</ProprietaryName>
<NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204398</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pilocarpine hydrochloride ophthalmic solution is indicated for the.</IndicationAndUsage>
<Description>Pilocarpine Hydrochloride Ophthalmic Solution, USP is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:. Established name: Pilocarpine hydrochloride. Chemical name: 2(3H)-furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)-methyl]-monohydrochloride, (3S-cis)-. Molecular Formula: C11H16N2O2 HCl. Molecular Weight: 244.72. Each mL of Pilocarpine Hydrochloride Ophthalmic Solution, USP contains:. Active: Pilocarpine hydrochloride 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). Preservative: Benzalkonium chloride 0.01%. Inactives: Hypromellose (2910) 5 mg (0.5%), boric acid, sodium citrate, sodium chloride (present in 1% only); hydrochloric acid and/or sodium hydroxide (to adjust pH); water for injection. Pilocarpine Hydrochloride Ophthalmic Solution, USP has a pH of 3.5 to 5.5 and an osmolality of 270 to 350 mOsm/kg (1% product), 290 to 350 mOsm/kg (2% product) and 500 to 600 mOsm/kg (4% product).</Description>
</NDC>
<NDC>
<NDCCode>21130-226-10</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (21130-226-10) / 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0226-10</NDC11Code>
<ProductNDC>21130-226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stay Awake</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961121</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M011</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>CAFFEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-226-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 CARTON (21695-226-30)</PackageDescription>
<NDC11Code>21695-0226-30</NDC11Code>
<ProductNDC>21695-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lunesta</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021476</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. LUNESTA tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>22840-0226-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0226-2) </PackageDescription>
<NDC11Code>22840-0226-02</NDC11Code>
<ProductNDC>22840-0226</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Timothy-orchard Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Phleum Pratense And Dactylis Glomerata</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101843</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>5000; 5000</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>29300-226-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-01) </PackageDescription>
<NDC11Code>29300-0226-01</NDC11Code>
<ProductNDC>29300-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203458</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets, USP 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.</Description>
</NDC>
</NDCList>