{
"NDC": [
{
"NDCCode": "0941-0679-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0679-48)",
"NDC11Code": "00941-0679-48",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-05",
"PackageDescription": "2500 mL in 1 BAG (0941-0679-05) ",
"NDC11Code": "00941-0679-05",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0941-0679-06",
"PackageDescription": "2000 mL in 1 BAG (0941-0679-06) ",
"NDC11Code": "00941-0679-06",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0941-0679-45",
"PackageDescription": "1500 mL in 1 BAG (0941-0679-45)",
"NDC11Code": "00941-0679-45",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-47",
"PackageDescription": "2000 mL in 1 BAG (0941-0679-47)",
"NDC11Code": "00941-0679-47",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-51",
"PackageDescription": "1500 mL in 1 BAG (0941-0679-51)",
"NDC11Code": "00941-0679-51",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-52",
"PackageDescription": "2000 mL in 1 BAG (0941-0679-52) ",
"NDC11Code": "00941-0679-52",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0941-0679-53",
"PackageDescription": "2500 mL in 1 BAG (0941-0679-53) ",
"NDC11Code": "00941-0679-53",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0941-0409-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0409-48)",
"NDC11Code": "00941-0409-48",
"ProductNDC": "0941-0409",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal Low Calcium With Dextrose",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19780927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.3; 1.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "0941-0411-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0411-48)",
"NDC11Code": "00941-0411-48",
"ProductNDC": "0941-0411",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal Pd-2 With Dextrose",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19780927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 1.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "0941-0413-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0413-48)",
"NDC11Code": "00941-0413-48",
"ProductNDC": "0941-0413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal Pd-2 With Dextrose",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19780927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "0941-0415-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0415-48)",
"NDC11Code": "00941-0415-48",
"ProductNDC": "0941-0415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal Pd-2 With Dextrose",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19780927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 4.25; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "0941-0457-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0457-48)",
"NDC11Code": "00941-0457-48",
"ProductNDC": "0941-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal Low Calcium With Dextrose",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19780927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.3; 2.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "0941-0459-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0459-48)",
"NDC11Code": "00941-0459-48",
"ProductNDC": "0941-0459",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal Low Calcium With Dextrose",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19780927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.3; 4.25; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "11673-941-48",
"PackageDescription": "258 g in 1 CAN (11673-941-48) ",
"NDC11Code": "11673-0941-48",
"ProductNDC": "11673-941",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Target Up And Up Kids Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE",
"StrengthNumber": "30; 50; 40; 100",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures. ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "35000-941-48",
"PackageDescription": "1 TUBE in 1 CARTON (35000-941-48) / 226 g in 1 TUBE",
"NDC11Code": "35000-0941-48",
"ProductNDC": "35000-941",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Triple Action",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101201",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "71205-679-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (71205-679-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71205-0679-01",
"ProductNDC": "71205-679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20170630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203661",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2022-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella species, and S. aureus. Bone and Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci. Septicemia: Due to S. pneumoniae, S. aureus (penicillin-sensitive and penicillin-resistant), P. mirabilis, E. coli, and Klebsiella species. Endocarditis: Due to S. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection, USP may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection, USP should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection, USP may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP and other antibacterial drugs, Cefazolin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. Structural Formula. The sodium content is 48 mg (2 mEq sodium ion) per 1 gram of cefazolin. Cefazolin for Injection, USP is a sterile white or off-white powder or crystalline powder containing Cefazolin Sodium USP supplied in vials equivalent to 1 gram or 2 grams of cefazolin."
},
{
"NDCCode": "0941-0464-01",
"PackageDescription": "5000 mL in 1 BAG (0941-0464-01)",
"NDC11Code": "00941-0464-01",
"ProductNDC": "0941-0464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal For Peritoneal Dialysis",
"NonProprietaryName": "Anhydrouse Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "13.6; 5.38; 4.48; .184; .051",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-02-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0941-0465-01",
"PackageDescription": "5000 mL in 1 BAG (0941-0465-01)",
"NDC11Code": "00941-0465-01",
"ProductNDC": "0941-0465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal For Peritoneal Dialysis",
"NonProprietaryName": "Anhydrous Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "22.7; 5.38; 4.48; .184; .051",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-02-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0941-0466-01",
"PackageDescription": "5000 mL in 1 BAG (0941-0466-01)",
"NDC11Code": "00941-0466-01",
"ProductNDC": "0941-0466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dianeal For Peritoneal Dialysis",
"NonProprietaryName": "Anhydrous Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "38.6; 5.38; 4.48; .184; .051",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-02-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0941-0709-05",
"PackageDescription": "5 BAG in 1 CARTON (0941-0709-05) / 2500 mL in 1 BAG (0941-0709-01) ",
"NDC11Code": "00941-0709-05",
"ProductNDC": "0941-0709",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20241110",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "257; 75; 51; 5.35; 4.48",
"StrengthUnit": "mg/1000mL; g/1000mL; mg/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241110",
"SamplePackage": "N"
},
{
"NDCCode": "24470-941-10",
"PackageDescription": "285 g in 1 BOTTLE, PLASTIC (24470-941-10) ",
"NDC11Code": "24470-0941-10",
"ProductNDC": "24470-941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plexion",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cintex Services, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "98; 48",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium lithium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "0074-0679-99",
"PackageDescription": "1 BAG in 1 CONTAINER (0074-0679-99) > 17600 TABLET, FILM COATED in 1 BAG",
"NDC11Code": "00074-0679-99",
"ProductNDC": "0074-0679",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Olaparib",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20180907",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "OLAPARIB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-12-20",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "07-SEP-18"
},
{
"NDCCode": "0078-0679-19",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0679-19) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0078-0679-61) ",
"NDC11Code": "00078-0679-19",
"ProductNDC": "0078-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zofran",
"ProprietaryNameSuffix": "Odt",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20170823",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020781",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170823",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "0113-0679-64",
"PackageDescription": "1 TUBE in 1 CARTON (0113-0679-64) / 28 g in 1 TUBE",
"NDC11Code": "00113-0679-64",
"ProductNDC": "0113-0679",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Triple Antibiotic",
"ProprietaryNameSuffix": "And Pain Relief",
"NonProprietaryName": "Bacitracin, Neomycin, Polymyxin B, Pramoxine Hcl",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060214",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 3.5; 10000; 10",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g; mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060214",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection and for temporary relief of pain or discomfort in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "0283-0679-02",
"PackageDescription": "59.7 g in 1 CAN (0283-0679-02) ",
"NDC11Code": "00283-0679-02",
"ProductNDC": "0283-0679",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hurricaine",
"ProprietaryNameSuffix": "Topical Anesthetic",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "SPRAY",
"RouteName": "DENTAL; ORAL; PERIODONTAL",
"StartMarketingDate": "19790615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Beutlich Pharmaceuticals, LLC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19790615",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of occasional minor irritation and pain, associated with: 1 canker sores, 2 sore mouth and throat, 3 minor injury of the mouth and gums, 4 minor dental proedures, 5 minor irritation of the mouth and gums caused by dentures or orthodontic appliances."
},
{
"NDCCode": "0283-0679-60",
"PackageDescription": "1 CAN in 1 BOX (0283-0679-60) / 59.7 g in 1 CAN (0283-0679-02) ",
"NDC11Code": "00283-0679-60",
"ProductNDC": "0283-0679",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hurricaine",
"ProprietaryNameSuffix": "Topical Anesthetic",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "SPRAY",
"RouteName": "DENTAL; ORAL; PERIODONTAL",
"StartMarketingDate": "19790615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Beutlich Pharmaceuticals, LLC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19790615",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of occasional minor irritation and pain, associated with: 1 canker sores, 2 sore mouth and throat, 3 minor injury of the mouth and gums, 4 minor dental proedures, 5 minor irritation of the mouth and gums caused by dentures or orthodontic appliances."
},
{
"NDCCode": "0310-0679-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0310-0679-12) ",
"NDC11Code": "00310-0679-12",
"ProductNDC": "0310-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lynparza",
"NonProprietaryName": "Olaparib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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<Description>EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0941-0679-53</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0679-53) </PackageDescription>
<NDC11Code>00941-0679-53</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>7.5; 535; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].</IndicationAndUsage>
<Description>EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0941-0409-48</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0409-48)</PackageDescription>
<NDC11Code>00941-0409-48</NDC11Code>
<ProductNDC>0941-0409</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal Low Calcium With Dextrose</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19780927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.3; 1.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0411-48</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0411-48)</PackageDescription>
<NDC11Code>00941-0411-48</NDC11Code>
<ProductNDC>0941-0411</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal Pd-2 With Dextrose</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19780927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 1.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0413-48</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0413-48)</PackageDescription>
<NDC11Code>00941-0413-48</NDC11Code>
<ProductNDC>0941-0413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal Pd-2 With Dextrose</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19780927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0415-48</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0415-48)</PackageDescription>
<NDC11Code>00941-0415-48</NDC11Code>
<ProductNDC>0941-0415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal Pd-2 With Dextrose</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19780927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 4.25; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0457-48</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0457-48)</PackageDescription>
<NDC11Code>00941-0457-48</NDC11Code>
<ProductNDC>0941-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal Low Calcium With Dextrose</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19780927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.3; 2.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0459-48</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0459-48)</PackageDescription>
<NDC11Code>00941-0459-48</NDC11Code>
<ProductNDC>0941-0459</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal Low Calcium With Dextrose</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19780927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.3; 4.25; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-941-48</NDCCode>
<PackageDescription>258 g in 1 CAN (11673-941-48) </PackageDescription>
<NDC11Code>11673-0941-48</NDC11Code>
<ProductNDC>11673-941</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Target Up And Up Kids Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE</SubstanceName>
<StrengthNumber>30; 50; 40; 100</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures. ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-941-48</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-941-48) / 226 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0941-48</NDC11Code>
<ProductNDC>35000-941</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Triple Action</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-679-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BOX (71205-679-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71205-0679-01</NDC11Code>
<ProductNDC>71205-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20170630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203661</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella species, and S. aureus. Bone and Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci. Septicemia: Due to S. pneumoniae, S. aureus (penicillin-sensitive and penicillin-resistant), P. mirabilis, E. coli, and Klebsiella species. Endocarditis: Due to S. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection, USP may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection, USP should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection, USP may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP and other antibacterial drugs, Cefazolin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. Structural Formula. The sodium content is 48 mg (2 mEq sodium ion) per 1 gram of cefazolin. Cefazolin for Injection, USP is a sterile white or off-white powder or crystalline powder containing Cefazolin Sodium USP supplied in vials equivalent to 1 gram or 2 grams of cefazolin.</Description>
</NDC>
<NDC>
<NDCCode>0941-0464-01</NDCCode>
<PackageDescription>5000 mL in 1 BAG (0941-0464-01)</PackageDescription>
<NDC11Code>00941-0464-01</NDC11Code>
<ProductNDC>0941-0464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal For Peritoneal Dialysis</ProprietaryName>
<NonProprietaryName>Anhydrouse Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>13.6; 5.38; 4.48; .184; .051</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0941-0465-01</NDCCode>
<PackageDescription>5000 mL in 1 BAG (0941-0465-01)</PackageDescription>
<NDC11Code>00941-0465-01</NDC11Code>
<ProductNDC>0941-0465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal For Peritoneal Dialysis</ProprietaryName>
<NonProprietaryName>Anhydrous Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>22.7; 5.38; 4.48; .184; .051</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0941-0466-01</NDCCode>
<PackageDescription>5000 mL in 1 BAG (0941-0466-01)</PackageDescription>
<NDC11Code>00941-0466-01</NDC11Code>
<ProductNDC>0941-0466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dianeal For Peritoneal Dialysis</ProprietaryName>
<NonProprietaryName>Anhydrous Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>38.6; 5.38; 4.48; .184; .051</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0941-0709-05</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (0941-0709-05) / 2500 mL in 1 BAG (0941-0709-01) </PackageDescription>
<NDC11Code>00941-0709-05</NDC11Code>
<ProductNDC>0941-0709</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20241110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>257; 75; 51; 5.35; 4.48</StrengthNumber>
<StrengthUnit>mg/1000mL; g/1000mL; mg/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>24470-941-10</NDCCode>
<PackageDescription>285 g in 1 BOTTLE, PLASTIC (24470-941-10) </PackageDescription>
<NDC11Code>24470-0941-10</NDC11Code>
<ProductNDC>24470-941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plexion</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cintex Services, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>98; 48</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium lithium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>0074-0679-99</NDCCode>
<PackageDescription>1 BAG in 1 CONTAINER (0074-0679-99) > 17600 TABLET, FILM COATED in 1 BAG</PackageDescription>
<NDC11Code>00074-0679-99</NDC11Code>
<ProductNDC>0074-0679</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Olaparib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20180907</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>OLAPARIB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-12-20</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-SEP-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0078-0679-19</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0679-19) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0078-0679-61) </PackageDescription>
<NDC11Code>00078-0679-19</NDC11Code>
<ProductNDC>0078-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zofran</ProprietaryName>
<ProprietaryNameSuffix>Odt</ProprietaryNameSuffix>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170823</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020781</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170823</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0113-0679-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0113-0679-64) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>00113-0679-64</NDC11Code>
<ProductNDC>0113-0679</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Triple Antibiotic</ProprietaryName>
<ProprietaryNameSuffix>And Pain Relief</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin, Neomycin, Polymyxin B, Pramoxine Hcl</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 3.5; 10000; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection and for temporary relief of pain or discomfort in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0283-0679-02</NDCCode>
<PackageDescription>59.7 g in 1 CAN (0283-0679-02) </PackageDescription>
<NDC11Code>00283-0679-02</NDC11Code>
<ProductNDC>0283-0679</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hurricaine</ProprietaryName>
<ProprietaryNameSuffix>Topical Anesthetic</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>DENTAL; ORAL; PERIODONTAL</RouteName>
<StartMarketingDate>19790615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Beutlich Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of occasional minor irritation and pain, associated with: 1 canker sores, 2 sore mouth and throat, 3 minor injury of the mouth and gums, 4 minor dental proedures, 5 minor irritation of the mouth and gums caused by dentures or orthodontic appliances.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0283-0679-60</NDCCode>
<PackageDescription>1 CAN in 1 BOX (0283-0679-60) / 59.7 g in 1 CAN (0283-0679-02) </PackageDescription>
<NDC11Code>00283-0679-60</NDC11Code>
<ProductNDC>0283-0679</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hurricaine</ProprietaryName>
<ProprietaryNameSuffix>Topical Anesthetic</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>DENTAL; ORAL; PERIODONTAL</RouteName>
<StartMarketingDate>19790615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Beutlich Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of occasional minor irritation and pain, associated with: 1 canker sores, 2 sore mouth and throat, 3 minor injury of the mouth and gums, 4 minor dental proedures, 5 minor irritation of the mouth and gums caused by dentures or orthodontic appliances.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0310-0679-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (0310-0679-12) </PackageDescription>
<NDC11Code>00310-0679-12</NDC11Code>
<ProductNDC>0310-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lynparza</ProprietaryName>
<NonProprietaryName>Olaparib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208558</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>OLAPARIB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated. Ovarian cancer: 1 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.1, 2.1) , 2 in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. , 3 Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.2, 2.1), 4 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.3, 2.1).</IndicationAndUsage>
<Description>Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. The chemical name is 4-[(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one. The empirical molecular formula for Lynparza is C24H23FN4O3 and the relative molecular mass is 434.46. It has the following chemical structure. Olaparib is a crystalline solid, is non-chiral and shows pH-independent low solubility across the physiological pH range. Lynparza (olaparib) tablets for oral use contain 100 mg or 150 mg of olaparib. Inactive ingredients in the tablet core are copovidone, mannitol, colloidal silicon dioxide, and sodium stearyl fumarate. The tablet coating consists of hypromellose, polyethylene glycol 400, titanium dioxide, ferric oxide yellow, and ferrosoferric oxide (150 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>0310-0679-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0310-0679-60) </PackageDescription>
<NDC11Code>00310-0679-60</NDC11Code>
<ProductNDC>0310-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lynparza</ProprietaryName>
<NonProprietaryName>Olaparib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208558</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>OLAPARIB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated. Ovarian cancer: 1 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.1, 2.1) , 2 in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. , 3 Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.2, 2.1), 4 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.3, 2.1).</IndicationAndUsage>
<Description>Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. The chemical name is 4-[(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one. The empirical molecular formula for Lynparza is C24H23FN4O3 and the relative molecular mass is 434.46. It has the following chemical structure. Olaparib is a crystalline solid, is non-chiral and shows pH-independent low solubility across the physiological pH range. Lynparza (olaparib) tablets for oral use contain 100 mg or 150 mg of olaparib. Inactive ingredients in the tablet core are copovidone, mannitol, colloidal silicon dioxide, and sodium stearyl fumarate. The tablet coating consists of hypromellose, polyethylene glycol 400, titanium dioxide, ferric oxide yellow, and ferrosoferric oxide (150 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>0310-0679-95</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0310-0679-95) </PackageDescription>
<NDC11Code>00310-0679-95</NDC11Code>
<ProductNDC>0310-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lynparza</ProprietaryName>
<NonProprietaryName>Olaparib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208558</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>OLAPARIB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170831</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated. Ovarian cancer: 1 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.1, 2.1) , 2 in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. , 3 Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.2, 2.1), 4 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.3, 2.1).</IndicationAndUsage>
<Description>Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. The chemical name is 4-[(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one. The empirical molecular formula for Lynparza is C24H23FN4O3 and the relative molecular mass is 434.46. It has the following chemical structure. Olaparib is a crystalline solid, is non-chiral and shows pH-independent low solubility across the physiological pH range. Lynparza (olaparib) tablets for oral use contain 100 mg or 150 mg of olaparib. Inactive ingredients in the tablet core are copovidone, mannitol, colloidal silicon dioxide, and sodium stearyl fumarate. The tablet coating consists of hypromellose, polyethylene glycol 400, titanium dioxide, ferric oxide yellow, and ferrosoferric oxide (150 mg tablet only).</Description>
</NDC>
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