{
"NDC": [
{
"NDCCode": "63776-245-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-245-26)",
"NDC11Code": "63776-0245-26",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-038-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-038-26)",
"NDC11Code": "63776-0038-26",
"ProductNDC": "63776-038",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Metenkefalin, Metenkefalin, Ersofermin, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Mecasermin Rinfabate, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Cetermin",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS ANKLE JOINT; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; SUS SCROFA ANKLE JOINT; BOS TAURUS JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; METENKEFALIN; METENKEFALIN; ERSOFERMIN; ERSOFERMIN; BOS TAURUS HIP JOINT; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; SUS SCROFA HIP JOINT; MECASERMIN RINFABATE; MECASERMIN RINFABATE; BOS TAURUS KNEE JOINT; BOS TAURUS KNEE JOINT; SUS SCROFA KNEE JOINT; SUS SCROFA KNEE JOINT; CETERMIN; CETERMIN",
"StrengthNumber": "9; 30; 6; 200; 6; 200; 8; 30; 8; 30; 9; 200; 9; 200; 6; 200; 6; 200; 9; 200; 7; 200; 7; 200; 11; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-096-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-096-26)",
"NDC11Code": "63776-0096-26",
"ProductNDC": "63776-096",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pork Collagen",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "PORK COLLAGEN; PORK COLLAGEN",
"StrengthNumber": "8; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-101-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-101-26)",
"NDC11Code": "63776-0101-26",
"ProductNDC": "63776-101",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin,bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Erythrocytes, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Cetermin, Avotermin",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; ASCORBIC ACID; METENKEFALIN; METENKEFALIN; ERSOFERMIN; ERSOFERMIN; BOS TAURUS CARTILAGE; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; SUS SCROFA CARTILAGE; PORK COLLAGEN; PORK COLLAGEN; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; BEEF LIVER; BEEF LIVER; PORK LIVER; PORK LIVER; TRANSFORMING GROWTH FACTOR BETA-1; TRANSFORMING GROWTH FACTOR BETA-1; CETERMIN; CETERMIN; AVOTERMIN; AVOTERMIN",
"StrengthNumber": "9; 200; 8; 30; 9; 200; 9; 200; 6; 200; 6; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200; 7; 30; 11; 200; 7; 30",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-271-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-271-26)",
"NDC11Code": "63776-0271-26",
"ProductNDC": "63776-271",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Anti-interleukin-1.alpha. Apomorphine, Metenkefalin",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; METENKEFALIN",
"StrengthNumber": "200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-348-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-348-26)",
"NDC11Code": "63776-0348-26",
"ProductNDC": "63776-348",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Bos Taurus Hippocampus, Sus Scrofa Hippocampus, Mecasermin Rinfabate, Interleukin-10, Beef, Pork, Bos Taurus Nerve, Sus Scrofa Nerve, Transforming Growth Factor Beta-1",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; METENKEFALIN; METENKEFALIN; ERSOFERMIN; ERSOFERMIN; BOS TAURUS SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS HIPPOCAMPUS; BOS TAURUS HIPPOCAMPUS; SUS SCROFA HIPPOCAMPUS; SUS SCROFA HIPPOCAMPUS; MECASERMIN RINFABATE; MECASERMIN RINFABATE; INTERLEUKIN-10; INTERLEUKIN-10; BEEF; BEEF; PORK; PORK; BOS TAURUS NERVE; BOS TAURUS NERVE; SUS SCROFA NERVE; SUS SCROFA NERVE; TRANSFORMING GROWTH FACTOR BETA-1; TRANSFORMING GROWTH FACTOR BETA-1",
"StrengthNumber": "9; 30; 8; 30; 8; 30; 10; 30; 9; 30; 10; 30; 8; 30; 8; 30; 8; 30; 8; 30; 11; 200; 12; 30; 6; 30; 6; 30; 6; 30; 6; 30; 10; 30",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-386-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-386-26)",
"NDC11Code": "63776-0386-26",
"ProductNDC": "63776-386",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Bone, Sus Scrofa Bone, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Bos Taurus Parathyroid Gland, Sus Scrofa Parathyroid Gland, Vitamin D",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS BONE; BOS TAURUS BONE; SUS SCROFA BONE; SUS SCROFA BONE; CALCITONIN; CALCITONIN; BOS TAURUS CARTILAGE; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; SUS SCROFA CARTILAGE; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; INTERLEUKIN-3; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; VITAMIN D; VITAMIN D",
"StrengthNumber": "8; 200; 8; 200; 8; 200; 6; 200; 6; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200; 3; 30",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-401-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-401-26)",
"NDC11Code": "63776-0401-26",
"ProductNDC": "63776-401",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Metenkefalin, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Bos Taurus Limbic System, Sus Scrofa Limbic System, Bos Taurus Nerve, Sus Scrofa Nerve, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; METENKEFALIN; METENKEFALIN; BOS TAURUS HYPOTHALAMUS; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; BOS TAURUS LIMBIC SYSTEM; BOS TAURUS LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; BOS TAURUS NERVE; BOS TAURUS NERVE; SUS SCROFA NERVE; SUS SCROFA NERVE; BOS TAURUS PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PITUITARY GLAND",
"StrengthNumber": "9; 30; 8; 30; 8; 200; 8; 200; 6; 200; 6; 200; 6; 30; 6; 30; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-501-26",
"PackageDescription": "125 mL in 1 BOTTLE (63776-501-26)",
"NDC11Code": "63776-0501-26",
"ProductNDC": "63776-501",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Berberis Vulgaris Root, Activated Charcoal, Centaurea Benedicta, Silybum Marianum Seed, Colchicum Autumnale Bulb, Galium Aparine, Binetrakin, Beef Kidney, Pork Kidney, Beef Liverpork Liver, Lycopodium Clavatum Spore, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Mesenchyme, Sus Scrofa Mesenchyme, Strychnos Nux-vomica Seed, Taraxacum Officinale, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; .ALPHA.-LIPOIC ACID; BERBERIS VULGARIS ROOT; BERBERIS VULGARIS ROOT; ACTIVATED CHARCOAL; CENTAUREA BENEDICTA; CENTAUREA BENEDICTA; SILYBUM MARIANUM SEED; SILYBUM MARIANUM SEED; COLCHICUM AUTUMNALE BULB; COLCHICUM AUTUMNALE BULB; GALIUM APARINE; BINETRAKIN; BINETRAKIN; BEEF KIDNEY; BEEF KIDNEY; PORK KIDNEY; PORK KIDNEY; BEEF LIVER; BEEF LIVER; PORK LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; SUS SCROFA MESENCHYME; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; BOS TAURUS TONSIL; BOS TAURUS TONSIL; SUS SCROFA TONSIL; SUS SCROFA TONSIL; ASCORBIC ACID",
"StrengthNumber": "30; 30; 6; 30; 6; 30; 5; 200; 30; 6; 200; 6; 200; 6; 200; 30; 9; 30; 6; 30; 6; 30; 6; 30; 6; 30; 6; 6; 30; 6; 30; 6; 30; 6; 30; 7; 30; 6; 30; 6; 30; 6; 30; 30; 30; 6; 30; 6; 30; 30",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-20",
"PackageDescription": "4000 mL in 1 BOTTLE (63776-245-20)",
"NDC11Code": "63776-0245-20",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-21",
"PackageDescription": "2 mL in 1 BOTTLE (63776-245-21)",
"NDC11Code": "63776-0245-21",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-22",
"PackageDescription": "5 mL in 1 BOTTLE (63776-245-22)",
"NDC11Code": "63776-0245-22",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-23",
"PackageDescription": "10 mL in 1 BOTTLE (63776-245-23)",
"NDC11Code": "63776-0245-23",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-24",
"PackageDescription": "30 mL in 1 BOTTLE (63776-245-24)",
"NDC11Code": "63776-0245-24",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-25",
"PackageDescription": "50 mL in 1 BOTTLE (63776-245-25)",
"NDC11Code": "63776-0245-25",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-27",
"PackageDescription": "250 mL in 1 BOTTLE (63776-245-27)",
"NDC11Code": "63776-0245-27",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-28",
"PackageDescription": "500 mL in 1 BOTTLE (63776-245-28)",
"NDC11Code": "63776-0245-28",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-245-29",
"PackageDescription": "1000 mL in 1 BOTTLE (63776-245-29)",
"NDC11Code": "63776-0245-29",
"ProductNDC": "63776-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200",
"StrengthUnit": "[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11344-245-34",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (11344-245-34) ",
"NDC11Code": "11344-0245-34",
"ProductNDC": "11344-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090916",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "837",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20090916",
"SamplePackage": "N"
},
{
"NDCCode": "16571-245-03",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (16571-245-03) ",
"NDC11Code": "16571-0245-03",
"ProductNDC": "16571-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Itraconazole",
"NonProprietaryName": "Itraconazole",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205724",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ITRACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250203",
"SamplePackage": "N",
"IndicationAndUsage": "Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:1. Blastomycosis, pulmonary and extrapulmonary2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly.Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium).Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.)Description of Clinical Studies: Blastomycosis:Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases.Histoplasmosis:Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases.Histoplasmosis in HIV-infected patients:Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis:Analyses were conducted on data from an open-label, “single-patient-use” protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy.Onychomycosis of the toenail:Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail:Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.",
"Description": "Itraconazole is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. or(±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-oneItraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white to almost white powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1.Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres. Inactive ingredients are gelatin capsule, hypromellose, Polyethylene Glycol and Sugar spheres (composed of sucrose, corn starch). Gelatin capsules include gelatin and titanium dioxide. Black ink contains Iron Oxide Black, Potassium Hydroxide, Propylene Glycol, Shellac, and Strong Ammonia Solution. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "24979-245-07",
"PackageDescription": "90 TABLET in 1 BOTTLE (24979-245-07) ",
"NDC11Code": "24979-0245-07",
"ProductNDC": "24979-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tenormin",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018240",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. TENORMIN is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. TENORMIN may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. TENORMIN is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. TENORMIN is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.",
"Description": "TENORMIN® (atenolol), a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). TENORMIN is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate."
},
{
"NDCCode": "42385-928-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30) ",
"NDC11Code": "42385-0928-30",
"ProductNDC": "42385-928",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212786",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2023-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
},
{
"NDCCode": "42385-928-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90) ",
"NDC11Code": "42385-0928-90",
"ProductNDC": "42385-928",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212786",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2023-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
},
{
"NDCCode": "42385-929-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (42385-929-18) ",
"NDC11Code": "42385-0929-18",
"ProductNDC": "42385-929",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213038",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "400; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
"Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
},
{
"NDCCode": "42385-929-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42385-929-30) ",
"NDC11Code": "42385-0929-30",
"ProductNDC": "42385-929",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213038",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "400; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200514",
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<PackageDescription>125 mL in 1 BOTTLE (63776-245-26)</PackageDescription>
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<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
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<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-038-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-038-26)</PackageDescription>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Metenkefalin, Metenkefalin, Ersofermin, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Mecasermin Rinfabate, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Cetermin</NonProprietaryName>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
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<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS ANKLE JOINT; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; SUS SCROFA ANKLE JOINT; BOS TAURUS JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; METENKEFALIN; METENKEFALIN; ERSOFERMIN; ERSOFERMIN; BOS TAURUS HIP JOINT; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; SUS SCROFA HIP JOINT; MECASERMIN RINFABATE; MECASERMIN RINFABATE; BOS TAURUS KNEE JOINT; BOS TAURUS KNEE JOINT; SUS SCROFA KNEE JOINT; SUS SCROFA KNEE JOINT; CETERMIN; CETERMIN</SubstanceName>
<StrengthNumber>9; 30; 6; 200; 6; 200; 8; 30; 8; 30; 9; 200; 9; 200; 6; 200; 6; 200; 9; 200; 7; 200; 7; 200; 11; 200</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-096-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-096-26)</PackageDescription>
<NDC11Code>63776-0096-26</NDC11Code>
<ProductNDC>63776-096</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pork Collagen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PORK COLLAGEN; PORK COLLAGEN</SubstanceName>
<StrengthNumber>8; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-101-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-101-26)</PackageDescription>
<NDC11Code>63776-0101-26</NDC11Code>
<ProductNDC>63776-101</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin,bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Erythrocytes, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Cetermin, Avotermin</NonProprietaryName>
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<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; ASCORBIC ACID; METENKEFALIN; METENKEFALIN; ERSOFERMIN; ERSOFERMIN; BOS TAURUS CARTILAGE; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; SUS SCROFA CARTILAGE; PORK COLLAGEN; PORK COLLAGEN; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; BEEF LIVER; BEEF LIVER; PORK LIVER; PORK LIVER; TRANSFORMING GROWTH FACTOR BETA-1; TRANSFORMING GROWTH FACTOR BETA-1; CETERMIN; CETERMIN; AVOTERMIN; AVOTERMIN</SubstanceName>
<StrengthNumber>9; 200; 8; 30; 9; 200; 9; 200; 6; 200; 6; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200; 7; 30; 11; 200; 7; 30</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-271-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-271-26)</PackageDescription>
<NDC11Code>63776-0271-26</NDC11Code>
<ProductNDC>63776-271</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Anti-interleukin-1.alpha. Apomorphine, Metenkefalin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
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<StrengthNumber>200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-348-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-348-26)</PackageDescription>
<NDC11Code>63776-0348-26</NDC11Code>
<ProductNDC>63776-348</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Bos Taurus Hippocampus, Sus Scrofa Hippocampus, Mecasermin Rinfabate, Interleukin-10, Beef, Pork, Bos Taurus Nerve, Sus Scrofa Nerve, Transforming Growth Factor Beta-1</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; METENKEFALIN; METENKEFALIN; ERSOFERMIN; ERSOFERMIN; BOS TAURUS SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS HIPPOCAMPUS; BOS TAURUS HIPPOCAMPUS; SUS SCROFA HIPPOCAMPUS; SUS SCROFA HIPPOCAMPUS; MECASERMIN RINFABATE; MECASERMIN RINFABATE; INTERLEUKIN-10; INTERLEUKIN-10; BEEF; BEEF; PORK; PORK; BOS TAURUS NERVE; BOS TAURUS NERVE; SUS SCROFA NERVE; SUS SCROFA NERVE; TRANSFORMING GROWTH FACTOR BETA-1; TRANSFORMING GROWTH FACTOR BETA-1</SubstanceName>
<StrengthNumber>9; 30; 8; 30; 8; 30; 10; 30; 9; 30; 10; 30; 8; 30; 8; 30; 8; 30; 8; 30; 11; 200; 12; 30; 6; 30; 6; 30; 6; 30; 6; 30; 10; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-386-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-386-26)</PackageDescription>
<NDC11Code>63776-0386-26</NDC11Code>
<ProductNDC>63776-386</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Bone, Sus Scrofa Bone, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Bos Taurus Parathyroid Gland, Sus Scrofa Parathyroid Gland, Vitamin D</NonProprietaryName>
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<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS BONE; BOS TAURUS BONE; SUS SCROFA BONE; SUS SCROFA BONE; CALCITONIN; CALCITONIN; BOS TAURUS CARTILAGE; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; SUS SCROFA CARTILAGE; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; INTERLEUKIN-3; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; VITAMIN D; VITAMIN D</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 200; 6; 200; 6; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-401-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-401-26)</PackageDescription>
<NDC11Code>63776-0401-26</NDC11Code>
<ProductNDC>63776-401</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Metenkefalin, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Bos Taurus Limbic System, Sus Scrofa Limbic System, Bos Taurus Nerve, Sus Scrofa Nerve, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; METENKEFALIN; METENKEFALIN; BOS TAURUS HYPOTHALAMUS; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; BOS TAURUS LIMBIC SYSTEM; BOS TAURUS LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; BOS TAURUS NERVE; BOS TAURUS NERVE; SUS SCROFA NERVE; SUS SCROFA NERVE; BOS TAURUS PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PITUITARY GLAND</SubstanceName>
<StrengthNumber>9; 30; 8; 30; 8; 200; 8; 200; 6; 200; 6; 200; 6; 30; 6; 30; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-501-26</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (63776-501-26)</PackageDescription>
<NDC11Code>63776-0501-26</NDC11Code>
<ProductNDC>63776-501</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Berberis Vulgaris Root, Activated Charcoal, Centaurea Benedicta, Silybum Marianum Seed, Colchicum Autumnale Bulb, Galium Aparine, Binetrakin, Beef Kidney, Pork Kidney, Beef Liverpork Liver, Lycopodium Clavatum Spore, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Mesenchyme, Sus Scrofa Mesenchyme, Strychnos Nux-vomica Seed, Taraxacum Officinale, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; .ALPHA.-LIPOIC ACID; BERBERIS VULGARIS ROOT; BERBERIS VULGARIS ROOT; ACTIVATED CHARCOAL; CENTAUREA BENEDICTA; CENTAUREA BENEDICTA; SILYBUM MARIANUM SEED; SILYBUM MARIANUM SEED; COLCHICUM AUTUMNALE BULB; COLCHICUM AUTUMNALE BULB; GALIUM APARINE; BINETRAKIN; BINETRAKIN; BEEF KIDNEY; BEEF KIDNEY; PORK KIDNEY; PORK KIDNEY; BEEF LIVER; BEEF LIVER; PORK LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; SUS SCROFA MESENCHYME; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; BOS TAURUS TONSIL; BOS TAURUS TONSIL; SUS SCROFA TONSIL; SUS SCROFA TONSIL; ASCORBIC ACID</SubstanceName>
<StrengthNumber>30; 30; 6; 30; 6; 30; 5; 200; 30; 6; 200; 6; 200; 6; 200; 30; 9; 30; 6; 30; 6; 30; 6; 30; 6; 30; 6; 6; 30; 6; 30; 6; 30; 6; 30; 7; 30; 6; 30; 6; 30; 6; 30; 30; 30; 6; 30; 6; 30; 30</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-20</NDCCode>
<PackageDescription>4000 mL in 1 BOTTLE (63776-245-20)</PackageDescription>
<NDC11Code>63776-0245-20</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-21</NDCCode>
<PackageDescription>2 mL in 1 BOTTLE (63776-245-21)</PackageDescription>
<NDC11Code>63776-0245-21</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-22</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (63776-245-22)</PackageDescription>
<NDC11Code>63776-0245-22</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-23</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (63776-245-23)</PackageDescription>
<NDC11Code>63776-0245-23</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-24</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-245-24)</PackageDescription>
<NDC11Code>63776-0245-24</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-25</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-245-25)</PackageDescription>
<NDC11Code>63776-0245-25</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-27</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (63776-245-27)</PackageDescription>
<NDC11Code>63776-0245-27</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-28</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (63776-245-28)</PackageDescription>
<NDC11Code>63776-0245-28</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-245-29</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (63776-245-29)</PackageDescription>
<NDC11Code>63776-0245-29</NDC11Code>
<ProductNDC>63776-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; ASCORBIC ACID; BOS TAURUS BONE MARROW; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; FILGRASTIM; ALDESLEUKIN; ALDESLEUKIN; INTERFERON GAMMA-1A; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; BOS TAURUS LYMPH; SUS SCROFA LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCHES; BOS TAURUS PEYER'S PATCHES; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; BOS TAURUS THYMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>8; 200; 8; 200; 8; 30; 8; 30; 8; 30; 8; 200; 8; 200; 12; 200; 12; 200; 7; 200; 8; 200; 8; 200; 8; 200; 8; 200; 6; 200; 6; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11344-245-34</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (11344-245-34) </PackageDescription>
<NDC11Code>11344-0245-34</NDC11Code>
<ProductNDC>11344-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>837</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16571-245-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (16571-245-03) </PackageDescription>
<NDC11Code>16571-0245-03</NDC11Code>
<ProductNDC>16571-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Itraconazole</ProprietaryName>
<NonProprietaryName>Itraconazole</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205724</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ITRACONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:1. Blastomycosis, pulmonary and extrapulmonary2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly.Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium).Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.)Description of Clinical Studies: Blastomycosis:Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases.Histoplasmosis:Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases.Histoplasmosis in HIV-infected patients:Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis:Analyses were conducted on data from an open-label, “single-patient-use” protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy.Onychomycosis of the toenail:Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail:Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success relapsed.</IndicationAndUsage>
<Description>Itraconazole is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. or(±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-oneItraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white to almost white powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1.Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres. Inactive ingredients are gelatin capsule, hypromellose, Polyethylene Glycol and Sugar spheres (composed of sucrose, corn starch). Gelatin capsules include gelatin and titanium dioxide. Black ink contains Iron Oxide Black, Potassium Hydroxide, Propylene Glycol, Shellac, and Strong Ammonia Solution. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>24979-245-07</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (24979-245-07) </PackageDescription>
<NDC11Code>24979-0245-07</NDC11Code>
<ProductNDC>24979-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tenormin</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018240</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. TENORMIN is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. TENORMIN may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. TENORMIN is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. TENORMIN is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.</IndicationAndUsage>
<Description>TENORMIN® (atenolol), a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). TENORMIN is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42385-928-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30) </PackageDescription>
<NDC11Code>42385-0928-30</NDC11Code>
<ProductNDC>42385-928</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212786</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>600; 300; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
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<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
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<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
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<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
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<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
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<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
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