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{
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"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 15 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
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"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
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"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
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"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
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"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent (preservative free) or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
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"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent (preservative free) or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
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"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent (preservative free) or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
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"RouteName": "ORAL",
"StartMarketingDate": "20250505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075938",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250505",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.",
"Description": "Propafenone hydrochloride tablets, USP are an antiarrhythmic drug supplied in scored, film-coated tablets of 150, 225 and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride (HCl) is 2'-[2-Hydroxy-3-(propylamino)- propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium starch glycolate, macrogol, talc, titanium dioxide, glycerol monocaprylocaprate and polyvinyl alcohol."
},
{
"NDCCode": "64380-268-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-02) ",
"NDC11Code": "64380-0268-02",
"ProductNDC": "64380-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075938",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250505",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.",
"Description": "Propafenone hydrochloride tablets, USP are an antiarrhythmic drug supplied in scored, film-coated tablets of 150, 225 and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride (HCl) is 2'-[2-Hydroxy-3-(propylamino)- propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium starch glycolate, macrogol, talc, titanium dioxide, glycerol monocaprylocaprate and polyvinyl alcohol."
},
{
"NDCCode": "65145-200-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (65145-200-25) / 5 mL in 1 VIAL, SINGLE-DOSE (65145-200-01) ",
"NDC11Code": "65145-0200-25",
"ProductNDC": "65145-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "Caplin Steriles Limited",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260310",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "65145-201-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (65145-201-25) / 15 mL in 1 VIAL, SINGLE-DOSE (65145-201-01) ",
"NDC11Code": "65145-0201-25",
"ProductNDC": "65145-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "Caplin Steriles Limited",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260310",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "65145-202-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (65145-202-25) / 50 mL in 1 VIAL, SINGLE-DOSE (65145-202-01) ",
"NDC11Code": "65145-0202-25",
"ProductNDC": "65145-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "Caplin Steriles Limited",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260310",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "68462-728-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-728-25) / 5 mL in 1 VIAL, SINGLE-DOSE (68462-728-05) ",
"NDC11Code": "68462-0728-25",
"ProductNDC": "68462-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "68462-729-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-729-25) / 15 mL in 1 VIAL, SINGLE-DOSE (68462-729-15) ",
"NDC11Code": "68462-0729-25",
"ProductNDC": "68462-729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "68462-730-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-730-25) / 50 mL in 1 VIAL, SINGLE-DOSE (68462-730-50) ",
"NDC11Code": "68462-0730-25",
"ProductNDC": "68462-730",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220683",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "276; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "72572-309-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (72572-309-25) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "72572-0309-25",
"ProductNDC": "72572-309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218314",
"LabelerName": "Civica, Inc.",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS",
"StrengthNumber": "276; 142",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250813",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
},
{
"NDCCode": "43063-893-06",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (43063-893-06) ",
"NDC11Code": "43063-0893-06",
"ProductNDC": "43063-893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorazepate Dipotassium",
"NonProprietaryName": "Clorazepate Dipotassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075731",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLORAZEPATE DIPOTASSIUM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180912",
"SamplePackage": "N",
"IndicationAndUsage": "Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.",
"Description": "Chemically, clorazepate dipotassium USP is a benzodiazepine. The empirical formula is C 16H 11ClK 2N 2O 4; the molecular weight is 408.92; 1 H-1, 4-Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows:. The compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate dipotassium tablets USP contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium oxide heavy, magnesium stearate, microcrystalline cellulose, potassium carbonate anhydrous, potassium chloride, talc and the following coloring agents. 3.75 mg - FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake. 7.5 mg - D&C Red No. 6 Barium Lake and D&C Yellow No. 10 Lake. 15 mg - D&C Red No. 6 Barium Lake and FD&C Red No. 40 Lake."
},
{
"NDCCode": "0143-9247-01",
"PackageDescription": "1 VIAL in 1 BOX (0143-9247-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00143-9247-01",
"ProductNDC": "0143-9247",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexrazoxane",
"NonProprietaryName": "Dexrazoxane",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076068",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DEXRAZOXANE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytoprotective Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171005",
"SamplePackage": "N",
"IndicationAndUsage": "Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )].",
"Description": "Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (+)-(S)-4,4’-Propylenedi-2,6-piperazinedione. The structural formula is as follows. Structural Formula. C11H16N4O4 M.W. 268.27. Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0. Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. The reconstituted dexrazoxane for injection solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer’s Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH [see Dosage and Administration (2.1 , 2.3)]."
},
{
"NDCCode": "0143-9248-01",
"PackageDescription": "1 VIAL in 1 BOX (0143-9248-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00143-9248-01",
"ProductNDC": "0143-9248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexrazoxane",
"NonProprietaryName": "Dexrazoxane",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076068",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DEXRAZOXANE HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytoprotective Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171005",
"SamplePackage": "N",
"IndicationAndUsage": "Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )].",
"Description": "Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (+)-(S)-4,4’-Propylenedi-2,6-piperazinedione. The structural formula is as follows. Structural Formula. C11H16N4O4 M.W. 268.27. Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0. Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. The reconstituted dexrazoxane for injection solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer’s Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH [see Dosage and Administration (2.1 , 2.3)]."
},
{
"NDCCode": "0143-9445-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0143-9445-01) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00143-9445-01",
"ProductNDC": "0143-9445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251211",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217415",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).",
"Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown."
},
{
"NDCCode": "0143-9456-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01) / 7 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00143-9456-01",
"ProductNDC": "0143-9456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251211",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217415",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "350",
"StrengthUnit": "mg/7mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).",
"Description": "Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown."
},
{
"NDCCode": "0270-0523-30",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-0523-30) > 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00270-0523-30",
"ProductNDC": "0270-0523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sinografin",
"NonProprietaryName": "Diatrizoate Meglumine And Iodipamide Meglumine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAUTERINE",
"StartMarketingDate": "19581202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011324",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE",
"StrengthNumber": "527; 268",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0327-0012-30",
"PackageDescription": "30 BOTTLE in 1 CARTON (0327-0012-30) > 30 mL in 1 BOTTLE",
"NDC11Code": "00327-0012-30",
"ProductNDC": "0327-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renacidin",
"NonProprietaryName": "Citric Acid, Gluconolactone And Magnesium Carbonate",
"DosageFormName": "SOLUTION",
"RouteName": "IRRIGATION",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019481",
"LabelerName": "United-Guardian, Inc.",
"SubstanceName": "ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE",
"StrengthNumber": "6.602; .198; 3.268",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Irrigation [MoA]",
"Status": "Active",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.",
"Description": "Renacidin® (Citric Acid, Glucono delta-lactone, and Magnesium Carbonate) is a sterile, non-pyrogenic irrigation solution for use within the lower urinary tract in the dissolution of bladder calculi of the struvite or apatite variety, and prevention of encrustations of urethral catheters and cystostomy tubes. Each 30 mL of Renacidin contains:. Active ingredients: Citric Acid (anhydrous), USP 1980.6 mg C6H8O7Glucono delta-lactone, USP 59.4 mg C6H10O6Magnesium Carbonate, USP 980.4 mg (MgCO3)4 · Mg(OH)2 · 5H2O. Citric Acid. Glucono delta-lactone. Magnesium Carbonate. (MgCO3)4 · Mg(OH)2 · 5H2O. Inert ingredients:Benzoic Acid, USP 6.9 mg Solution pH: 3.85 (3.5-4.2)."
},
{
"NDCCode": "0409-0801-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0801-01",
"ProductNDC": "0409-0801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nipent",
"NonProprietaryName": "Pentostatin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020122",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "PENTOSTATIN",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070815",
"SamplePackage": "N",
"IndicationAndUsage": "NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.",
"Description": "NIPENT (pentostatin for injection) is supplied as a sterile, apyrogenic, lyophilized powder in single-dose vials for intravenous administration. Each vial contains 10 mg of pentostatin and 50 mg of Mannitol, USP. The pH of the final product is maintained between 7.0 and 8.5 by addition of sodium hydroxide or hydrochloric acid. Pentostatin, also known as 2'-deoxycoformycin (DCF), is a potent inhibitor of the enzyme adenosine deaminase and is isolated from fermentation cultures of Streptomyces antibioticus. Pentostatin is known chemically as (R)-3-(2-deoxy-ß-D-erythropentofuranosyl)3,6,7,8 tetrahydroimidazo[4,5d][1,3]diazepin-8-ol with a molecular formula of C11H16N4O4 and a molecular weight of 268.27. The molecular structure of pentostatin is. Pentostatin is a white to off-white solid, freely soluble in distilled water."
},
{
"NDCCode": "0615-8447-39",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8447-39) ",
"NDC11Code": "00615-8447-39",
"ProductNDC": "0615-8447",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220111",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215939",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230113",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine is an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine USP is a light orange to creamish white or off-white powder. Sparingly soluble in acetic acid, slightly soluble in chloroform and practically insoluble in water. Its molecular weight is 252.268. Oxcarbazepine film-coated tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, black iron oxide, iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
}
]
}
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<PackageDescription>1 KIT in 1 CARTON (43063-268-92) * 60 mL in 1 BOTTLE, PLASTIC * 30 TABLET in 1 BOTTLE, PLASTIC (55289-376-30)</PackageDescription>
<NDC11Code>43063-0268-92</NDC11Code>
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<ProprietaryName>Comfort Pac With Meloxicam</ProprietaryName>
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<StartMarketingDate>20130709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077923</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-07-13</LastUpdate>
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<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<PackageDescription>1 KIT in 1 CARTON (43063-038-92) * 60 mL in 1 BOTTLE, PLASTIC * 30 TABLET in 1 BOTTLE, PLASTIC (55289-140-30)</PackageDescription>
<NDC11Code>43063-0038-92</NDC11Code>
<ProductNDC>43063-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Comfort Pac With Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDCCode>43063-237-92</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (43063-237-92) * 60 mL in 1 BOTTLE, PLASTIC * 30 TABLET in 1 BOTTLE, PLASTIC (55289-784-30)</PackageDescription>
<NDC11Code>43063-0237-92</NDC11Code>
<ProductNDC>43063-237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Comfort Pac With Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
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<StartMarketingDate>20130709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076280</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-11-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<NDCCode>43063-419-92</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (43063-419-92) </PackageDescription>
<NDC11Code>43063-0419-92</NDC11Code>
<ProductNDC>43063-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>43063-526-92</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (43063-526-92) * 60 mL in 1 BOTTLE, PLASTIC * 30 TABLET in 1 BOTTLE, PLASTIC (43063-396-30)</PackageDescription>
<NDC11Code>43063-0526-92</NDC11Code>
<ProductNDC>43063-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Comfort Pac With Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077918</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-7391-72</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-7391-72) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-7391-82) </PackageDescription>
<NDC11Code>00409-7391-72</NDC11Code>
<ProductNDC>0409-7391</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic, Anhydrous</NonProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
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<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 15 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
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<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
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<IndicationAndUsage>Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
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<IndicationAndUsage>Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
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<IndicationAndUsage>Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent (preservative free) or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
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<IndicationAndUsage>Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent (preservative free) or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
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<IndicationAndUsage>Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent (preservative free) or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
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<IndicationAndUsage>Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.</IndicationAndUsage>
<Description>Propafenone hydrochloride tablets, USP are an antiarrhythmic drug supplied in scored, film-coated tablets of 150, 225 and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride (HCl) is 2'-[2-Hydroxy-3-(propylamino)- propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium starch glycolate, macrogol, talc, titanium dioxide, glycerol monocaprylocaprate and polyvinyl alcohol.</Description>
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<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.</IndicationAndUsage>
<Description>Propafenone hydrochloride tablets, USP are an antiarrhythmic drug supplied in scored, film-coated tablets of 150, 225 and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride (HCl) is 2'-[2-Hydroxy-3-(propylamino)- propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium starch glycolate, macrogol, talc, titanium dioxide, glycerol monocaprylocaprate and polyvinyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>65145-200-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (65145-200-25) / 5 mL in 1 VIAL, SINGLE-DOSE (65145-200-01) </PackageDescription>
<NDC11Code>65145-0200-25</NDC11Code>
<ProductNDC>65145-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>Caplin Steriles Limited</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>65145-201-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (65145-201-25) / 15 mL in 1 VIAL, SINGLE-DOSE (65145-201-01) </PackageDescription>
<NDC11Code>65145-0201-25</NDC11Code>
<ProductNDC>65145-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>Caplin Steriles Limited</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>65145-202-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (65145-202-25) / 50 mL in 1 VIAL, SINGLE-DOSE (65145-202-01) </PackageDescription>
<NDC11Code>65145-0202-25</NDC11Code>
<ProductNDC>65145-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<StartMarketingDate>20260310</StartMarketingDate>
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<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>Caplin Steriles Limited</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68462-728-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-728-25) / 5 mL in 1 VIAL, SINGLE-DOSE (68462-728-05) </PackageDescription>
<NDC11Code>68462-0728-25</NDC11Code>
<ProductNDC>68462-728</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68462-729-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-729-25) / 15 mL in 1 VIAL, SINGLE-DOSE (68462-729-15) </PackageDescription>
<NDC11Code>68462-0729-25</NDC11Code>
<ProductNDC>68462-729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68462-730-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (68462-730-25) / 50 mL in 1 VIAL, SINGLE-DOSE (68462-730-50) </PackageDescription>
<NDC11Code>68462-0730-25</NDC11Code>
<ProductNDC>68462-730</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220683</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>276; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium phosphates injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>72572-309-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (72572-309-25) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>72572-0309-25</NDC11Code>
<ProductNDC>72572-309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218314</ApplicationNumber>
<LabelerName>Civica, Inc.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS</SubstanceName>
<StrengthNumber>276; 142</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4 H2O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
</NDC>
<NDC>
<NDCCode>43063-893-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE, PLASTIC (43063-893-06) </PackageDescription>
<NDC11Code>43063-0893-06</NDC11Code>
<ProductNDC>43063-893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorazepate Dipotassium</ProprietaryName>
<NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075731</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.</IndicationAndUsage>
<Description>Chemically, clorazepate dipotassium USP is a benzodiazepine. The empirical formula is C 16H 11ClK 2N 2O 4; the molecular weight is 408.92; 1 H-1, 4-Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows:. The compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate dipotassium tablets USP contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium oxide heavy, magnesium stearate, microcrystalline cellulose, potassium carbonate anhydrous, potassium chloride, talc and the following coloring agents. 3.75 mg - FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake. 7.5 mg - D&C Red No. 6 Barium Lake and D&C Yellow No. 10 Lake. 15 mg - D&C Red No. 6 Barium Lake and FD&C Red No. 40 Lake.</Description>
</NDC>
<NDC>
<NDCCode>0143-9247-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (0143-9247-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>00143-9247-01</NDC11Code>
<ProductNDC>0143-9247</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexrazoxane</ProprietaryName>
<NonProprietaryName>Dexrazoxane</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076068</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEXRAZOXANE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )].</IndicationAndUsage>
<Description>Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (+)-(S)-4,4’-Propylenedi-2,6-piperazinedione. The structural formula is as follows. Structural Formula. C11H16N4O4 M.W. 268.27. Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0. Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. The reconstituted dexrazoxane for injection solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer’s Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH [see Dosage and Administration (2.1 , 2.3)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9248-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (0143-9248-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>00143-9248-01</NDC11Code>
<ProductNDC>0143-9248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexrazoxane</ProprietaryName>
<NonProprietaryName>Dexrazoxane</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076068</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEXRAZOXANE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )].</IndicationAndUsage>
<Description>Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (+)-(S)-4,4’-Propylenedi-2,6-piperazinedione. The structural formula is as follows. Structural Formula. C11H16N4O4 M.W. 268.27. Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0. Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. The reconstituted dexrazoxane for injection solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer’s Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH [see Dosage and Administration (2.1 , 2.3)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9445-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0143-9445-01) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00143-9445-01</NDC11Code>
<ProductNDC>0143-9445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251211</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217415</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).</IndicationAndUsage>
<Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown.</Description>
</NDC>
<NDC>
<NDCCode>0143-9456-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01) / 7 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00143-9456-01</NDC11Code>
<ProductNDC>0143-9456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251211</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217415</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/7mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daptomycin for Injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).</IndicationAndUsage>
<Description>Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is:. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7)]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown.</Description>
</NDC>
<NDC>
<NDCCode>0270-0523-30</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-0523-30) > 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00270-0523-30</NDC11Code>
<ProductNDC>0270-0523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sinografin</ProprietaryName>
<NonProprietaryName>Diatrizoate Meglumine And Iodipamide Meglumine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAUTERINE</RouteName>
<StartMarketingDate>19581202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011324</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE</SubstanceName>
<StrengthNumber>527; 268</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-12</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0327-0012-30</NDCCode>
<PackageDescription>30 BOTTLE in 1 CARTON (0327-0012-30) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00327-0012-30</NDC11Code>
<ProductNDC>0327-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renacidin</ProprietaryName>
<NonProprietaryName>Citric Acid, Gluconolactone And Magnesium Carbonate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019481</ApplicationNumber>
<LabelerName>United-Guardian, Inc.</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE</SubstanceName>
<StrengthNumber>6.602; .198; 3.268</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Irrigation [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.</IndicationAndUsage>
<Description>Renacidin® (Citric Acid, Glucono delta-lactone, and Magnesium Carbonate) is a sterile, non-pyrogenic irrigation solution for use within the lower urinary tract in the dissolution of bladder calculi of the struvite or apatite variety, and prevention of encrustations of urethral catheters and cystostomy tubes. Each 30 mL of Renacidin contains:. Active ingredients: Citric Acid (anhydrous), USP 1980.6 mg C6H8O7Glucono delta-lactone, USP 59.4 mg C6H10O6Magnesium Carbonate, USP 980.4 mg (MgCO3)4 · Mg(OH)2 · 5H2O. Citric Acid. Glucono delta-lactone. Magnesium Carbonate. (MgCO3)4 · Mg(OH)2 · 5H2O. Inert ingredients:Benzoic Acid, USP 6.9 mg Solution pH: 3.85 (3.5-4.2).</Description>
</NDC>
<NDC>
<NDCCode>0409-0801-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0801-01</NDC11Code>
<ProductNDC>0409-0801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nipent</ProprietaryName>
<NonProprietaryName>Pentostatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20070815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020122</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>PENTOSTATIN</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.</IndicationAndUsage>
<Description>NIPENT (pentostatin for injection) is supplied as a sterile, apyrogenic, lyophilized powder in single-dose vials for intravenous administration. Each vial contains 10 mg of pentostatin and 50 mg of Mannitol, USP. The pH of the final product is maintained between 7.0 and 8.5 by addition of sodium hydroxide or hydrochloric acid. Pentostatin, also known as 2'-deoxycoformycin (DCF), is a potent inhibitor of the enzyme adenosine deaminase and is isolated from fermentation cultures of Streptomyces antibioticus. Pentostatin is known chemically as (R)-3-(2-deoxy-ß-D-erythropentofuranosyl)3,6,7,8 tetrahydroimidazo[4,5d][1,3]diazepin-8-ol with a molecular formula of C11H16N4O4 and a molecular weight of 268.27. The molecular structure of pentostatin is. Pentostatin is a white to off-white solid, freely soluble in distilled water.</Description>
</NDC>
<NDC>
<NDCCode>0615-8447-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8447-39) </PackageDescription>
<NDC11Code>00615-8447-39</NDC11Code>
<ProductNDC>0615-8447</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220111</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215939</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230113</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine is an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine USP is a light orange to creamish white or off-white powder. Sparingly soluble in acetic acid, slightly soluble in chloroform and practically insoluble in water. Its molecular weight is 252.268. Oxcarbazepine film-coated tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, black iron oxide, iron oxide yellow, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
</NDCList>